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Trial record 19 of 117 for:    DUTASTERIDE

Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02014584
Recruitment Status : Completed
First Posted : December 18, 2013
Results First Posted : March 8, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alopecia
Interventions Drug: Dutasteride
Drug: Placebo
Enrollment 117
Recruitment Details The study consisted of a Screening Visit, a 4-week Placebo Run-in Period, a 24-week Double-Blind (DB) Treatment Period, followed by a 24-week Open-Label (OL) Active Treatment Period, and a 4-week post-treatment Follow-Up Visit.
Pre-assignment Details Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
Arm/Group Title Placebo Dutasteride 0.5 mg Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) Targeted F/U: Placebo (DB)/Dutasteride 0.5 mg (OL) Targeted F/U: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description Participants received placebo administered orally once daily for 24 weeks. Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period. During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period. Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study treatment administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first. Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study drug administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
Period Title: Double-Blind Period (24 Weeks)
Started 59 58 0 0 0 0
Completed 57 52 0 0 0 0
Not Completed 2 6 0 0 0 0
Reason Not Completed
Protocol Violation             0             1             0             0             0             0
Withdrawal by Subject             2             5             0             0             0             0
Period Title: Open-Label Period (24 Weeks)
Started 0 0 49 48 0 0
Completed 0 0 44 47 0 0
Not Completed 0 0 5 1 0 0
Reason Not Completed
Lost to Follow-up             0             0             2             0             0             0
Withdrawal by Subject             0             0             3             1             0             0
Period Title: Target Follow-up (F/U) Period (24 Weeks)
Started 0 0 0 0 3 2
Completed 0 0 0 0 2 2
Not Completed 0 0 0 0 1 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1             0
Arm/Group Title Placebo Dutasteride 0.5 mg Total
Hide Arm/Group Description Participants received placebo administered orally once daily for 24 weeks. Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 59 58 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 58 participants 117 participants
39.0  (6.77) 39.1  (6.65) 39.0  (6.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
59
 100.0%
58
 100.0%
117
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
Asian - East Asian Heritage 49 48 97
Asian - Southeast Asian Heritage 1 0 1
White - White/Caucasian/European Heritage 9 10 19
1.Primary Outcome
Title Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least one dose of study treatment.
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
5 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Fisher’s Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
-4.7 to 18.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population: all participants who entered the open-label period.
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
3 2
3.Primary Outcome
Title Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Dutasteride DB/OL Combined: all participants who entered the OL Period and taken Dutasteride in both the DB and the OL periods.
Arm/Group Title Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
10
4.Secondary Outcome
Title Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: Days
Altered (decreased) libido n=2,1 88.5  (103.94) 44.0 [1]   (NA)
Impotence, n=3, 7 68.3  (73.35) 78.6  (83.09)
Ejaculation disorder, n=0, 1 NA [2]   (NA) 63.0 [1]   (NA)
[1]
The standard deviation was not calculated as only 1 participant was analyzed.
[2]
The mean and standard deviation was not calculated as no participants were analyzed.
5.Secondary Outcome
Title Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: Days
Altered (decreased) libido n=2,1 77.5  (71.42) 135.0 [1]   (NA)
Impotence, n=1, 1 181.0 [2]   (NA) 176.0 [1]   (NA)
Ejaculation disorder, n=0, 0 NA [3]   (NA) NA [3]   (NA)
[1]
The standard deviation was not calculated as only 1 participant was analyzed.
[2]
The mean and standard deviation was not calculated as only 1 participant was analyzed.
[3]
The mean and standard deviation was not calculated as no participants were analyzed.
6.Secondary Outcome
Title Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Dutasteride DB/OL Combined population
Arm/Group Title Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: Days
Altered (decreased) libido n=1 135.0 [1]   (NA)
Impotence, n=8 90.8  (84.28)
Ejaculation disorder, n=1 63.0 [1]   (NA)
[1]
The standard deviation was not calculated as only 1 participant was analyzed.
7.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
0 0
8.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
0 0
9.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Dutasteride DB/OL Combined population
Arm/Group Title Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
0
10.Secondary Outcome
Title Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
Any AE 18 19
Any SAE 1 1
PSRAE 0 0
11.Secondary Outcome
Title Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
Any AE 13 15
Any SAE 1 0
PSRAE 0 0
12.Secondary Outcome
Title Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Dutasteride DB/OL Combined population
Arm/Group Title Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
Any AE 25
Any SAE 1
PSRAE 0
13.Secondary Outcome
Title Number of Participants With Treatment-related AEs in the Double-blind Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
5 11
14.Secondary Outcome
Title Number of Participants With Treatment-related AEs in the Open-label Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
4 2
15.Secondary Outcome
Title Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibility of being caused by the investigational product or whose classification was missing.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Dutasteride DB/OL Combined population
Arm/Group Title Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
11
16.Secondary Outcome
Title Number of Participants With AEs of Special Interest in the Double-blind Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
Altered (decreased libido) 2 1
Impotence 3 7
Ejaculation disorders 0 1
Breast disorder 0 0
Prostate cancer 0 0
Cardiovascular adverse event 0 0
Infrequent adverse events 0 1
17.Secondary Outcome
Title Number of Participants With AEs of Special Interest in the Open-label Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
Altered (decreased libido) 2 1
Impotence 1 1
Ejaculation disorders 0 0
Breast disorder 0 0
Prostate cancer 0 0
Cardiovascular adverse event 0 0
Infrequent adverse events 0 1
18.Secondary Outcome
Title Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods
Hide Description An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Dutasteride DB/OL Combined population
Arm/Group Title Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
Altered (decreased libido) 1
Impotence 8
Ejaculation disorders 1
Breast disorder 0
Prostate cancer 0
Cardiovascular adverse event 0
Infrequent adverse events 2
19.Secondary Outcome
Title Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period
Hide Description Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3..without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
Wish to be dead 0 0
Non-specific suicidal thoughts 0 0
Without intent 0 0
With intent but no plan 0 0
With plan and intent 0 0
Prep acts/behavior 0 0
Aborted attempt 0 0
Interrupted attempt 0 0
Actual attempt 0 0
Non-suicidal self injury behavior 0 0
20.Secondary Outcome
Title Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period
Hide Description Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3. without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
Wish to be dead 0 0
Non-specific suicidal thoughts 0 0
Without intent 0 0
With intent but no plan 0 0
With plan and intent 0 0
Prep acts/behavior 0 0
Aborted attempt 0 0
Interrupted attempt 0 0
Actual attempt 0 0
Non-suicidal self injury behavior 0 0
21.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period
Hide Description The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
SBP Week 12, n=59, 53 0.9  (9.71) -0.1  (10.46)
SBP Week 24, n=57, 52 -1.0  (13.27) -2.0  (14.08)
DBP Week 12, n=59, 53 2.1  (7.99) 1.6  (9.23)
DBP Week 24, n=57, 52 -0.2  (9.78) -1.5  (9.73)
22.Secondary Outcome
Title Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period
Hide Description Baseline blood presure assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP Week 12, n=46, 48 -0.9  (10.02) 0.1  (12.76)
SBP Week 24, n=44, 47 -0.7  (11.30) 0.4  (12.90)
DBP Week 12, n=46, 48 -0.8  (8.87) -0.6  (9.00)
DBP Week 24, n=44, 47 -1.4  (8.26) 0.9  (11.23)
23.Secondary Outcome
Title Change From Baseline in Heart Rate in the Double-blind Treatment Period
Hide Description The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: Beats per Minute
Week 12, n=59, 53 0.3  (8.19) -0.6  (11.39)
Week 24, n=57, 52 0.6  (9.21) -0.7  (11.20)
24.Secondary Outcome
Title Change From Baseline in Heart Rate in the Open-label Treatment Period
Hide Description Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: Beats per Minute
Week 12, n=46, 48 -1.5  (10.86) 1.1  (13.15)
Week 24, n=44, 47 -0.3  (10.83) 1.2  (11.26)
25.Secondary Outcome
Title Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period
Hide Description The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for vital signs was defined as: Systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
Baseline SBP <80 mmHg 0 0
Baseline SBP >165 mmHg 0 0
Baseline DBP <40 mmHg 0 0
Baseline DBP >105 mmHg 0 0
Post Baseline SBP <80 mmHg 0 0
Post Baseline SBP >165 mmHg 0 0
Post Baseline DBP <40 mmHg 0 0
Post Baseline DBP >105 mmHg 1 2
26.Secondary Outcome
Title Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period
Hide Description The Baseline blood presssure assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for vital signs was defined as: systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
Baseline SBP <80 mmHg 0 0
Baseline SBP >165 mmHg 0 0
Baseline DBP <40 mmHg 0 0
Baseline DBP >105 mmHg 0 0
Post Baseline SBP <80 mmHg 0 0
Post Baseline SBP >165 mmHg 0 0
Post Baseline DBP <40 mmHg 0 0
Post Baseline DBP >105 mmHg 0 0
27.Secondary Outcome
Title Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period
Hide Description The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
Baseline <40 0 0
Baseline >100 1 1
Post- Baseline <40 0 0
Post- Baseline >100 1 2
28.Secondary Outcome
Title Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period
Hide Description Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
Baseline <40 0 0
Baseline >100 1 1
Post- Baseline <40 0 0
Post- Baseline >100 3 5
29.Secondary Outcome
Title Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period
Hide Description Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: Giga per Liter (GI/L)
Platelet Count DB Week 24, n=54, 47 2.2  (37.79) 9.6  (24.01)
Platelet Count Final Value, n=55, 48 2.3  (37.45) 9.0  (23.93)
WBC DB Week 24, n=55, 51 0.1  (1.39) 0.1  (1.32)
WBC Final Value, n=56, 52 0.1  (1.35) 0.1  (1.16)
Basophils DB Week 24, n=50, 46 -0.0  (0.03) -0.0  (0.03)
Basophils Final Value, n=51, 47 -0.0  (0.03) -0.0  (0.03)
Eosinophils DB Week 24, n=50, 46 -0.0  (0.15) -0.0  (0.11)
Eosinophils Final Value, n=51, 47 -0.0  (0.15) -0.0  (0.13)
Lymphocytes DB Week 24, n=50, 46 0.0  (0.76) -0.1  (0.59)
Lymphocytes Final Value, n=51, 47 0.1  (0.75) -0.0  (0.59)
Monocytes DB Week 24, n=50, 46 0.0  (0.16) -0.0  (0.13)
Monocytes Final Value, n=51, 47 0.0  (0.16) -0.0  (0.13)
Segmented Neutrophils DB Week 24, n=50, 46 0.1  (1.27) 0.2  (1.31)
Segmented Neutrophils Final Value, n=51, 47 0.1  (1.26) 0.2  (1.14)
Total Neutrophils DB Week 24, n=50, 46 0.1  (1.27) 0.2  (1.31)
Total Neutrophils Final Value, n=51, 47 0.1  (1.26) 0.2  (1.14)
30.Secondary Outcome
Title Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period
Hide Description Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: Giga per Liter (GI/L)
Platelet Count OL Week 24, n=42, 45 2.1  (30.41) -2.5  (19.83)
Platelet Count Final Value, n=42, 45 2.1  (30.41) -3.4  (20.33)
WBC OL Week 24, n=42, 47 0.2  (1.23) 0.2  (1.71)
WBC Final Value, n=42, 47 0.1  (1.25) 0.1  (1.68)
Basophils OL Week 24, n=39, 44 -0.0  (0.02) 0.0  (0.02)
Basophils Final Value, n=40, 44 -0.0  (0.02) 0.0  (0.02)
Eosinophils OL Week 24, n=39, 44 -0.0  (0.17) 0.0  (0.14)
Eosinophils Final Value, n=40, 44 -0.0  (0.17) 0.0  (0.14)
Lymphocytes OL Week 24, n=39, 44 -0.0  (0.47) 0.1  (0.50)
Lymphocytes Final Value, n=40, 44 -0.0  (0.46) 0.1  (0.50)
Monocytes OL Week 24, n=39, 44 -0.0  (0.12) -0.0  (0.12)
Monocytes Final Value, n=40, 44 -0.0  (0.13) -0.0  (0.12)
Segmented Neutrophils OL Week 24, n=39, 44 0.2  (1.19) 0.0  (1.72)
Segmented Neutrophils Final Value, n=40, 44 0.2  (1.20) 0.0  (1.72)
Total Neutrophils OL Week 24, n=39, 44 0.2  (1.19) 0.0  (1.72)
Total Neutrophils Final Value, n=40, 44 0.2  (1.20) 0.0  (1.72)
31.Secondary Outcome
Title Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit
Hide Description Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: Proportion of RBCs
DB Week 24, n=55, 51 -0.0  (0.02) 0.0  (0.02)
Final Value, n=56, 52 -0.0  (0.02) 0.0  (0.02)
32.Secondary Outcome
Title Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit
Hide Description Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: Proportion of RBCs
OL Week 24, n=43, 47 0.0  (0.02) 0.0  (0.02)
Final Value, n=43, 47 0.0  (0.02) 0.0  (0.02)
33.Secondary Outcome
Title Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin
Hide Description Hematology parameter included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: G/L
DB Week 24, n=55, 51 -2.0  (6.56) -0.8  (5.33)
Final Value, n=56, 52 -2.0  (6.46) -0.8  (5.68)
34.Secondary Outcome
Title Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin
Hide Description Hematology parameters included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: G/L
OL Week 24, n=43, 47 -1.5  (7.65) -1.4  (5.30)
Final Value, n=43, 47 -1.5  (7.65) -1.4  (5.30)
35.Secondary Outcome
Title Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count
Hide Description Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: T/L
DB Week 24, n=55, 51 -0.0  (0.25) 0.0  (0.20)
Final Value, n=56, 52 -0.0  (0.25) 0.0  (0.21)
36.Secondary Outcome
Title Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count
Hide Description Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: T/L
OL Week 24, n=43, 47 -0.1  (0.27) -0.1  (0.20)
Final Value, n=43, 47 -0.1  (0.27) -0.1  (0.20)
37.Secondary Outcome
Title Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein
Hide Description Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: G/L
Albumin, DB Week 24, n=57, 52 0.2  (1.82) -0.1  (2.15)
Albumin, Final Value, n=58, 53 0.2  (1.81) -0.1  (2.21)
Total Protein, DB Week 24, n=57, 52 -0.1  (3.14) -0.0  (3.64)
Total Protein, Final Value, n=58, 53 -0.1  (3.09) 0.1  (3.79)
38.Secondary Outcome
Title Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein
Hide Description Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: G/L
Albumin OL Week 24, n=44, 47 -0.6  (2.02) -1.1  (2.02)
Albumin Final Value, n=44, 47 -0.5  (2.05) -1.1  (2.02)
Total Protein OL Week 24, n=44, 47 -0.8  (3.90) -2.4  (3.23)
Total Protein Final Value, n=44, 47 -0.7  (3.94) -2.4  (3.23)
39.Secondary Outcome
Title Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period
Hide Description Clinical chemistry parameters included: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT) at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: IU/L
ALT DB Week 24, n=57, 52 0.9  (21.69) 4.0  (12.70)
ALT Final Value, n=58, 53 1.0  (21.51) 3.5  (12.37)
ALP DB Week 24, n=57, 52 -4.8  (10.41) -4.1  (8.16)
ALP Final Value, n=58, 53 -4.8  (10.35) -4.5  (8.82)
AST DB Week 24, n=57, 51 0.7  (10.42) 0.5  (6.99)
AST Final Value, n=58, 52 0.6  (10.34) 0.3  (6.65)
GGT DB Week 24, n=57, 52 -6.4  (30.95) -1.1  (15.84)
GGT Final Value, n=58, 53 -6.3  (30.69) -1.1  (15.67)
40.Secondary Outcome
Title Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period
Hide Description Clinical chemistry parameters included: ALT, ALP, AST, and GGT at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: IU/L
ALT OL Week 24, n=44, 47 -1.4  (19.22) -1.7  (13.07)
ALT Final Value, n=44, 47 -1.3  (19.25) -1.7  (13.07)
ALP OL Week 24, n=44, 47 0.0  (9.87) -3.3  (7.59)
ALP Final Value, n=44, 47 0.0  (9.85) -3.3  (7.59)
AST OL Week 24, n=43, 47 -0.2  (7.00) 0.1  (8.90)
AST Final Value, n=44, 47 -0.5  (7.18) 0.1  (8.90)
GGT OL Week 24, n=44, 47 3.7  (13.13) 0.6  (19.59)
GGT Final Value, n=44, 47 3.7  (13.13) 0.6  (19.59)
41.Secondary Outcome
Title Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin
Hide Description Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: UMOL/L
Creatinine DB Week 24, n=57, 52 1.7  (8.20) -0.7  (9.41)
Creatinine Final Value, n=58, 53 1.6  (8.12) -0.8  (9.37)
Direct bilirubin DB Week 24, n=57, 52 -0.2  (0.86) -0.3  (0.93)
Direct bilirubin Final Value, n=58, 53 -0.1  (0.90) -0.2  (0.93)
Total bilirubin DB Week 24, n=57, 52 -1.1  (4.66) -1.1  (4.56)
Total bilirubin Final Value, n=58, 53 -1.1  (4.65) -1.0  (4.36)
42.Secondary Outcome
Title Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin.
Hide Description Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: UMOL/L
Creatinine OL Week 24, n=44, 47 1.1  (12.01) -0.2  (6.66)
Creatinine Final Value, n=44, 47 1.2  (12.01) -0.2  (6.66)
Direct bilirubin OL Week 24, n=44, 47 0.1  (0.89) 0.1  (1.02)
Direct bilirubin Final Value, n=44, 47 0.1  (0.90) 0.1  (1.02)
Total bilirubin OL Week 24, n=44, 47 0.9  (3.84) 0.4  (5.10)
Total bilirubin Final Value, n=44, 47 1.0  (3.91) 0.4  (5.10)
43.Secondary Outcome
Title Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
Hide Description Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: MMOL/L
Glucose DB Week 24, n=57, 52 0.1  (1.58) 0.0  (0.36)
Glucose Final Value, n=58, 53 0.1  (1.57) 0.0  (1.18)
Potassium DB Week 24, n=57, 51 0.0  (0.32) 0.0  (0.29)
Potassium Final Value n=58, 52 0.0  (0.32) 0.0  (0.30)
Sodium DB Week 24, n=57, 52 0.5  (1.60) 0.2  (2.13)
Sodium Final Value, n=58, 53 0.5  (1.61) 0.4  (1.87)
Urea/BUN Final Value, n=57, 52 0.2  (1.22) 0.0  (1.32)
Urea/BUN Value, n=58, 53 0.2  (1.23) 0.1  (1.33)
44.Secondary Outcome
Title Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN.
Hide Description Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: MMOL/L
Glucose OL Week 24, n=44, 47 0.3  (1.48) 0.2  (1.13)
Glucose Final Value, n=44, 47 0.3  (1.48) 0.2  (1.13)
Potassium OL Week 24, n=43, 47 -0.1  (0.36) -0.0  (0.30)
Potassium Final Value, n=44, 47 -0.0  (0.37) -0.0  (0.30)
Sodium OL Week 24, n=44, 47 -0.9  (2.51) -0.6  (1.79)
Sodium Final Value, n=44, 47 -0.9  (2.51) -0.6  (1.79)
Urea/BUN OL Week 24, n=44, 47 0.3  (1.50) -0.1  (1.15)
Urea/BUN Final Value, n=44, 47 0.3  (1.50) -0.1  (1.15)
45.Secondary Outcome
Title Incidence of Premature Discontinuations in the Double-blind Treatment Period
Hide Description Participants were referred as premature discontinuations if they do not complete the double-blind period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
2 6
46.Secondary Outcome
Title Incidence of Premature Discontinuations in the Open-label Treatment Period
Hide Description Participants were referred as premature discontinuations if they do not complete the open-label treatment period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
5 1
47.Secondary Outcome
Title Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period
Hide Description The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.
Time Frame Baseline, Week 4, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
DB Week 4 3 1
DB Week 12 4 7
DB Week 24 3 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Fisher’s Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-10.4 to 3.4
Estimation Comments DB Week 4
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Fisher’s Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-4.7 to 17.6
Estimation Comments DB Week 12
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Fisher’s Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
-4.2 to 16.7
Estimation Comments DB Week 24
48.Secondary Outcome
Title Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period
Hide Description The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.
Time Frame Baseline, Week 4, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
OL Week 4 2 2
OL Week 12 2 3
OL Week 24 1 5
49.Secondary Outcome
Title Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period
Hide Description The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
DB Week 4, n=56, 54 -1.4  (0.56) -0.0  (0.57)
DB Week 12, n= 59, 53 -0.9  (0.75) -2.2  (0.79)
DB Week 24, n=57, 51 -1.2  (0.71) -1.2  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-0.2 to 3.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.80
Estimation Comments DB Week 4
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-3.4 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.09
Estimation Comments DB Week 12
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.0 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments DB Week 24
50.Secondary Outcome
Title Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period
Hide Description The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
OL Week 4, n=47, 48 0.4  (5.55) 0.2  (3.04)
OL Week 12, n=46, 48 -0.6  (5.28) -0.3  (5.34)
OL Week 24, n=44, 47 -0.1  (5.73) -2.6  (11.05)
51.Secondary Outcome
Title Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period
Hide Description The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
Erectile Function DB Week 4, n=56, 54 -0.5  (0.23) -0.3  (0.24)
Erectile Function DB Week 12, n= 59, 53 -0.5  (0.35) -1.3  (0.37)
Erectile Function DB Week 24, n=57, 52 -0.5  (0.42) -1.2  (0.44)
Intercourse satisfaction DB Week 4, n=56, 54 -0.3  (0.16) 0.0  (0.16)
Intercourse satisfaction DB Week 12, n=59, 53 -0.1  (0.23) -0.2  (0.24)
Intercourse satisfaction DB Week 24, n=57, 52 -0.3  (0.23) -0.4  (0.24)
Orgasmic function DB Week 4, n=56, 54 -0.0  (0.11) 0.1  (0.11)
Orgasmic function DB Week 12, n=59, 53 0.0  (0.10) -0.1  (0.11)
Orgasmic function DB Week 24, n=57, 52 -0.0  (0.15) -0.1  (0.16)
Sexual desire DB Week 4, n=56, 54 -0.4  (0.14) -0.1  (0.15)
Sexual desire DB Week 12, n=59, 53 -0.2  (0.15) -0.4  (0.16)
Sexual desire DB Week 24, n=57, 52 -0.2  (0.18) -0.2  (0.19)
Overall sexual satisfaction DB Week 4, n=56, 54 -0.1  (0.12) 0.1  (0.12)
Overall sexual satisfaction DB Week 12, n=59, 53 -0.1  (0.13) -0.2  (0.14)
Overall sexual satisfaction DB Week 24, n=57, 51 -0.1  (0.15) -0.2  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.4 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.33
Estimation Comments Erectile Function DB Week 4
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.8 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.52
Estimation Comments Erectile Function DB Week 12
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.9 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.61
Estimation Comments Erectile Function DB Week 24
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.1 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments Intercourse satisfaction DB Week 4
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.8 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.33
Estimation Comments Intercourse satisfaction DB Week 12
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.8 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.34
Estimation Comments Intercourse satisfaction DB Week 24
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Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.16
Estimation Comments Orgasmic function DB Week 4
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Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.5 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments Orgasmic function DB Week 12
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Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.6 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.23
Estimation Comments Orgasmic function DB Week 24
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.1 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.21
Estimation Comments Sexual desire DB Week 4
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Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.7 to 0.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments Sexual desire DB Week 12
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-0.5 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.27
Estimation Comments Sexual desire DB Week 24
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Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.2 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.17
Estimation Comments Overall sexual satisfaction DB Week 4
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Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.20
Estimation Comments Overall sexual satisfaction DB Week 12
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Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.22
Estimation Comments Overall sexual satisfaction DB Week 24
52.Secondary Outcome
Title Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period
Hide Description The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 4, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Erectile Function OL Week 4, n=47, 48 0.0  (2.30) -0.1  (1.76)
Erectile Function OL Week 12, n= 46, 48 -0.1  (1.86) -0.3  (2.99)
Erectile Function OL Week 24, n=44, 47 0.0  (1.62) -1.4  (5.22)
Intercourse satisfaction OL Week 4, n=47, 48 0.1  (1.45) 0.0  (1.03)
Intercourse satisfaction OL Week 12, n= 46, 48 -0.2  (1.57) -0.1  (1.93)
Intercourse satisfaction OL Week 24, n=44, 47 -0.1  (1.93) -0.5  (2.60)
Orgasmic function OL Week 4, n=47, 48 0.1  (0.88) 0.1  (0.65)
Orgasmic function OL Week 12, n= 46, 48 0.0  (0.80) -0.1  (0.56)
Orgasmic function OL Week 24, n=44, 47 0.1  (0.80) -0.4  (2.12)
Sexual desire OL Week 4, n=47, 48 0.1  (1.50) 0.0  (1.01)
Sexual desire OL Week 12, n= 46, 48 -0.2  (1.60) -0.1  (1.07)
Sexual desire OL Week 24, n=44, 47 -0.0  (1.72) -0.1  (1.04)
Overall sexual satisfaction OL Week 4, n=47, 48 0.0  (1.13) 0.1  (0.73)
Overall sexual satisfaction OL Week 12, n= 46, 48 -0.2  (0.99) 0.2  (0.71)
Overall sexual satisfaction OL Week 24, n=44, 47 -0.2  (1.10) -0.1  (1.45)
53.Secondary Outcome
Title Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period
Hide Description The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7= very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
DB Week 12, n= 58, 53 1.3  (0.79) 2.4  (0.82)
DB Week 24, n=57, 52 -0.1  (0.79) 3.2  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-1.1 to 3.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.14
Estimation Comments DB Week 12
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
1.1 to 5.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.14
Estimation Comments DB Week 24
54.Secondary Outcome
Title Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period
Hide Description The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7=very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 44 47
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
4.5  (6.96) 4.5  (7.23)
55.Secondary Outcome
Title Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period
Hide Description The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
DB Week 12, n= 58, 53 0.2  (0.35) -0.4  (0.37)
DB Week 24, n=57, 52 0.7  (0.52) 0.2  (0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-1.7 to 0.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments DB Week 12
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dutasteride 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method t-test from general linear model
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.0 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.76
Estimation Comments DB Week 24
56.Secondary Outcome
Title Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period
Hide Description The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value.
Time Frame Baseline and Upto Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label Period Population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
-1.0  (3.92) -0.8  (3.77)
57.Secondary Outcome
Title Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period
Hide Description The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the DB treatment start.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo Dutasteride 0.5 mg
Hide Arm/Group Description:
Participants received placebo administered orally once daily for 24 weeks.
Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: Participants
Baseline, Erection ability, Very Much Better 0 0
Baseline, Erection ability, Much Better 1 1
Baseline, Erection ability, A Little Better 1 1
Baseline, Erection ability, No change 54 55
Baseline, Erection ability, A Little Worse 3 1
Baseline, Erection ability, Much worse 0 0
Baseline, Erection ability, Very Much Worse 0 0
Baseline, Sexual life, Very Much Better 0 0
Baseline, sexual life, Much Better 1 1
Baseline, sexual life, A Little Better 1 0
Baseline, sexual life, No change 55 56
Baseline, sexual life, A Little Worse 2 1
Baseline, sexual life, Much worse 0 0
Baseline, sexual life, Very Much Worse 0 0
DB week 24, Erection ability, Very Much Better 1 0
DB week 24, Erection ability, Much Better 0 0
DB week 24, Erection ability, A Little Better 2 4
DB week 24, Erection ability, No change 49 40
DB week 24, Erection ability, A Little Worse 5 7
DB week 24, Erection ability, Much worse 0 1
DB week 24, Erection ability, Very Much Worse 0 0
DB week 24, Sexual life, Very Much Better 1 0
DB week 24, sexual life, Much Better 0 1
DB week 24, sexual life, A Little Better 3 2
DB week 24, sexual life, No change 47 39
DB week 24, sexual life, A Little Worse 6 9
DB week 24, sexual life, Much worse 0 1
DB week 24, sexual life, Very Much Worse 0 0
58.Secondary Outcome
Title Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period
Hide Description The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the OL treatment start.
Time Frame Baseline and up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
open-label period population
Arm/Group Title Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description:
During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
Overall Number of Participants Analyzed 49 48
Measure Type: Number
Unit of Measure: Participants
OL Baseline, Erection ability, Very Much Better 1 0
OL Baseline, Erection ability, Much Better 0 0
OL Baseline, Erection ability, A Little Better 1 4
OL Baseline, Erection ability, No change 42 39
OL Baseline, Erection ability, A Little Worse 5 5
OL Baseline, Erection ability, Much worse 0 0
OL Baseline, Erection ability, Very Much Worse 0 0
OL Baseline, Sexual life, Very Much Better 1 0
OL Baseline, sexual life, Much Better 0 1
OL Baseline, sexual life, A Little Better 2 2
OL Baseline, sexual life, No change 40 39
OL Baseline, sexual life, A Little Worse 6 6
OL Baseline, sexual life, Much worse 0 0
OL Baseline, sexual life, Very Much Worse 0 0
OL week 24, Erection ability, Very Much Better 0 0
OL week 24, Erection ability, Much Better 2 0
OL week 24, Erection ability, A Little Better 1 4
OL week 24, Erection ability, No change 35 37
OL week 24, Erection ability, A Little Worse 6 5
OL week 24, Erection ability, Much worse 0 0
OL week 24, Erection ability, Very Much Worse 0 0
OL week 24, Sexual life, Very Much Better 0 0
OL week 24, sexual life, Much Better 2 1
OL week 24, sexual life, A Little Better 1 2
OL week 24, sexual life, No change 37 39
OL week 24, sexual life, A Little Worse 4 4
OL week 24, sexual life, Much worse 0 0
OL week 24, sexual life, Very Much Worse 0 0
Time Frame Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks).
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs are reported for Safety Population.
 
Arm/Group Title Placebo (DB) Dutasteride 0.5 mg (DB) Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo (DB) Dutasteride 0.5 mg (DB) Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (DB) Dutasteride 0.5 mg (DB) Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/59 (1.69%)   1/58 (1.72%)   1/49 (2.04%)   0/48 (0.00%)   1/48 (2.08%) 
Metabolism and nutrition disorders           
Hypokalaemia  1  0/59 (0.00%)  1/58 (1.72%)  0/49 (0.00%)  0/48 (0.00%)  1/48 (2.08%) 
Musculoskeletal and connective tissue disorders           
Intervertebral disc protrusion  1  1/59 (1.69%)  0/58 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (DB) Dutasteride 0.5 mg (DB) Placebo (DB)/Dutasteride 0.5 mg (OL) Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/59 (8.47%)   10/58 (17.24%)   1/49 (2.04%)   4/48 (8.33%)   13/48 (27.08%) 
Reproductive system and breast disorders           
Erectile dysfunction  1  3/59 (5.08%)  7/58 (12.07%)  1/49 (2.04%)  0/48 (0.00%)  7/48 (14.58%) 
Respiratory, thoracic and mediastinal disorders           
Nasopharyngitis  1  2/59 (3.39%)  4/58 (6.90%)  0/49 (0.00%)  4/48 (8.33%)  8/48 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT02014584     History of Changes
Other Study ID Numbers: 200209
First Submitted: December 12, 2013
First Posted: December 18, 2013
Results First Submitted: November 10, 2016
Results First Posted: March 8, 2017
Last Update Posted: October 11, 2018