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Trial record 25 of 117 for:    DUTASTERIDE

A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

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ClinicalTrials.gov Identifier: NCT00441116
Recruitment Status : Completed
First Posted : February 28, 2007
Results First Posted : April 22, 2009
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alopecia
Intervention Drug: Dutasteride 0.5mg oral tablets
Enrollment 153
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. Subjects who were given no Investigational product.
Period Title: Overall Study
Started 76 77
Completed 73 75
Not Completed 3 2
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             1             0
Did not meet Eligibility Criteria             1             1
Arm/Group Title Dutasteride Placebo Total
Hide Arm/Group Description Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. Subjects who were given no Investigational product. Total of all reporting groups
Overall Number of Baseline Participants 76 77 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 77 participants 153 participants
37.78  (7.07) 38.41  (6.61) 38.097  (6.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 77 participants 153 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
76
 100.0%
77
 100.0%
153
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Democratic People's Republic of Number Analyzed 76 participants 77 participants 153 participants
76 77 153
1.Primary Outcome
Title Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
Hide Description The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: hair count per centimeters squared
Baseline 148.14  (36.27) 144.27  (32.33)
Month 6 162.27  (38.52) 149.57  (34.44)
Change from Baseline - Month 6 12.21  (23.60) 4.67  (16.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dutasteride, Placebo
Comments Month 6 - Baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0319
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 7.54
Confidence Interval 95%
0.75 to 14.33
Parameter Dispersion
Type: Standard Deviation
Value: 20.37
Estimation Comments Mean difference = Drug A minus Drug B
2.Secondary Outcome
Title Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.
Hide Description The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.
Time Frame Baseline and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: hair count per centimeters squared
Baseline 148.14  (36.27) 144.27  (32.33)
Month 3 160.19  (36.73) 154.50  (36.87)
Change from Baseline - Month 3 7.58  (22.70) 10.24  (19.02)
3.Secondary Outcome
Title Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?
Hide Description GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Much less hair (Month 3) 5 4
Moderately less hair (Month 3) 8 7
Slightly less hair (Month 3) 26 26
The same amount of hair (Month 3) 32 36
Slightly more hair (Month 3) 1 2
Moderately more hair (Month 3) 1 0
Much more hair (Month 3) 0 0
Much less hair (Month 6) 9 7
Moderately less hair (Month 6) 13 8
Slightly less hair (Month 6) 24 22
The same amount of hair (Month 6) 25 35
Slightly more hair (Month 6) 2 3
Moderately more hair (Month 6) 0 0
Much more hair (Month 6) 0 0
4.Secondary Outcome
Title Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?
Hide Description GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
I strongly disagree (month 3) 0 1
I disagree (month 3) 18 30
No opinion either way (month 3) 20 13
I agree (month 3) 34 30
I strongly agree (month 3) 1 1
I strongly disagree (month 6) 0 0
I disagree (month 6) 18 27
No opinion either way (month 6) 12 17
I agree (month 6) 40 29
I strongly agree (month 6) 3 2
5.Secondary Outcome
Title Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is?
Hide Description GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Much worse (Month 3) 0 0
Moderately worse (Month 3) 0 1
Slightly worse (Month 3) 1 4
Not Changed (Month 3) 36 47
Slightly Better (Month 3) 25 20
Moderately Better (Month 3) 7 3
Much Better (Month 3) 4 0
Much worse (Month 6) 0 0
Moderately worse (Month 6) 1 0
Slightly worse (Month 6) 2 10
Not changed (Month 6) 23 33
Slightly Better (Month 6) 26 29
Moderately Better (Month 6) 11 3
Much Better (Month 6) 10 0
6.Secondary Outcome
Title Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?
Hide Description GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
I strongly disagree (Month 3) 0 0
I disagree (Month 3) 4 8
No opinion either way (Month 3) 5 11
I agree(Month 3) 62 56
I strongly agree (Month 3) 2 0
I strongly disagree (Month 6) 0 0
I disagree (Month 6) 3 8
No opinion either way (Month 6) 3 9
I agree (Month 6) 60 58
I strongly agree(Month 6) 7 0
7.Secondary Outcome
Title Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See?
Hide Description GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Much less scalp (month 3) 10 3
Moderately less scalp (month 3) 17 11
Slightly less scalp (month 3) 25 17
The same amount of scalp (month 3) 14 26
Slightly more scalp (month 3) 3 14
Moderately more scalp (month 3) 1 4
Much more scalp (month 3) 3 0
Much less scalp (month 6) 9 2
Moderately less scalp (month 6) 16 5
Slightly less scalp (month 6) 26 15
The same amount of scalp (month 6) 20 26
Slightly more scalp (month 6) 1 22
Moderately more scalp (month 6) 1 4
Much more scalp (month 6) 0 1
8.Secondary Outcome
Title Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?
Hide Description GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Much less scalp (Month 3) 1 1
Moderately less scalp (Month 3) 2 3
Slightly less scalp (Month 3) 3 14
The same amount of scalp (Month 3) 20 24
Slightly more scalp (Month 3) 25 23
Moderately more scalp (Month 3) 15 7
Much more scalp (Month 3) 7 3
Much less scalp (Month 6) 0 2
Moderately less scalp (Month 6) 0 5
Slightly less scalp (Month 6) 2 21
The same amount of scalp (Month 6) 22 28
Slightly more scalp (Month 6) 17 17
Moderately more scalp (Month 6) 28 1
Much more scalp (Month 6) 4 1
9.Secondary Outcome
Title Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has?
Hide Description GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Greatly decreased (Month 3) 0 0
Moderately decreased (Month 3) 2 1
Slightly decreased (Month 3) 7 19
Stayed the same (Month 3) 17 21
Slightly increased (Month 3) 26 21
Moderately increased (Month 3) 15 10
Greatly increased (Month 3) 6 3
Greatly decreased (Month 6) 0 2
Moderately decreased (Month 6) 0 4
Slightly decreased (Month 6) 0 22
Stayed the same (Month 6) 22 26
Slightly increased (Month 6) 22 18
Moderately increased (Month 6) 23 2
Greatly increased (Month 6) 6 1
10.Secondary Outcome
Title Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is?
Hide Description GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Much Worse (Month 3) 0 0
Moderately Worse (Month 3) 2 1
Slightly Worse (Month 3) 2 9
Not Changed (Month 3) 16 28
Slightly Better (Month 3) 28 24
Moderately Better (Month 3) 14 9
Much Better (Month 3) 11 4
Much Worse (Month 6) 0 1
Moderately Worse (Month 6) 0 2
Slightly Worse (Month 6) 0 20
Not Changed (Month 6) 21 25
Slightly Better (Month 6) 24 23
Moderately Better (Month 6) 19 2
Much Better (Month 6) 9 2
11.Secondary Outcome
Title Investigator's Photographic Assessment of Improvement Distribution From Baseline
Hide Description Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Greatly decreased (Month 3) 0 0
Moderately decreased (Month 3) 1 1
Slightly decreased (Month 3) 0 13
No Change (Month 3) 28 30
Slightly increased (Month 3) 35 30
Moderately increased (Month 3) 8 1
Greatly increased (Month 3) 1 0
Greatly decreased (Month 6) 0 0
Moderately decreased (Month 6) 0 8
Slightly decreased (Month 6) 4 16
No Change (Month 6) 24 36
Slightly increased (Month 6) 31 14
Moderately increased (Month 6) 12 1
Greatly increased (Month 6) 2 0
12.Secondary Outcome
Title Investigator's Photographic Assessment of Improvements From Baseline Score
Hide Description Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change.
Time Frame Month 3 and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population (PP) defined as subjects in the ITT population taking study medication for 6 month and no identified as a major protocol violator.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 64 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 Mean Score 0.78  (0.79) 0.19  (0.78)
Month 6 Mean Score 0.88  (0.86) -0.30  (0.85)
13.Secondary Outcome
Title Panel Assessment of Improvement Distribution From Screening
Hide Description

Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count.

Score Range -3=greatly decreased to +3=greatly increased. 0=No change.

Time Frame Baseline to Month 3 and Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Greatly decreased (Month 3) 0 0
Moderately decreased (Month 3) 1 0
Slightly decreased (Month 3) 3 14
No change (Month 3) 28 29
Slightly increased (Month 3) 33 28
Moderately increased (Month 3) 8 4
Greatly increased (Month 3) 0 0
Greatly decreased (Month 6) 0 1
Moderately decreased (Month 6) 0 4
Slightly decreased (Month 6) 6 29
No Change (Month 6) 40 32
Slightly increased (Month 6) 20 8
Moderately increased (Month 6) 5 1
Greatly increased (Month 6) 2 0
14.Secondary Outcome
Title The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10
Hide Description Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value.
Time Frame Month 3, Month 6 and Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: Percent change
% Change in DHT - Month 3 -16.92  (54.14) -1.90  (47.58)
% Change in DHT - Month 6 -4.30  (38.73) 22.83  (45.30)
% Change in DHT - Month 10 3.85  (44.34) 7.58  (50.28)
15.Secondary Outcome
Title The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10
Hide Description Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml.
Time Frame Month 3, Month 6, and Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: Percent change
% Change in Testosterone - Month 3 18.78  (28.69) -5.27  (28.90)
% Change in Testosterone - Month 6 8.15  (30.18) -6.59  (31.86)
% Change in Testosterone - Month 10 12.18  (26.17) 0.99  (27.42)
16.Secondary Outcome
Title Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10.
Hide Description Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, <0.1, adult, 0.25-0.75; females (f): prepuberty, <0.03, premenopausal, 0.05-0.3, menopausal, <0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, >20; luteal 5-20; postmenopausal, >10 IU/L.
Time Frame Baseline to Month 6 and Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. LH was only assessed at baseline.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
TSH - Baseline - Normal 70 75
TSH - Baseline - Abnormal 3 0
TSH - Month 6 - Normal 70 69
TSH - Month 6 - Abnormal 0 4
TSH - Month 10 - Normal 71 74
TSH - Month 10 - Abnormal 1 1
T4 - Baseline - Normal 73 75
T4 - Baseline - Abnormal 0 0
T4 - Month 6 - Normal 70 71
T4 - Month 6 - Abnormal 0 2
T4 - Month 10 - Normal 72 74
T4 - Month 10 - Abnormal 0 1
PSA - Screening - Normal 73 75
PSA - Screening - Abnormal 0 0
PSA - Month 6 - Normal 70 73
PSA - Month 6 - Abnormal 0 0
PSA - Month 10 - Normal 72 75
PSA - Month 10 - Abnormal 0 0
DHT - Screening - Normal 72 74
DHT - Screening - Abnormal 1 1
DHT - Month 6 - Normal 69 69
DHT - Month 6 - Abnormal 1 4
DHT - Month 10 - Normal 70 72
DHT - Month 10 - Abnormal 2 3
Testosterone - Screening - Normal 73 74
Testosterone - Screening - Abnormal 0 1
Testosterone - Month 6 - Normal 67 71
Testosterone - Month 6 - Abnormal 3 2
Testosterone - Month 10 - Normal 69 74
Testosterone - Month 10 - Abnormal 3 1
LH - Baseline - Normal 67 64
LH - Baseline - Abnormal 6 11
17.Secondary Outcome
Title Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.
Hide Description Sodium, Potassium (mEq/L), and Bicarbonate
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: mmol/L
Sodium - Baseline 141.23  (1.72) 141.41  (1.62)
Sodium - Month 6 141.54  (2.01) 141.58  (1.65)
Potassium (mEq/L) - Baseline 4.22  (0.31) 4.34  (0.33)
Potassium (mEq/L) - Month 6 4.25  (0.32) 4.29  (0.26)
Bicarbonate - Baseline 27.66  (2.19) 28.23  (2.28)
Bicarbonate - Month 6 26.61  (2.12) 27.08  (2.30)
18.Secondary Outcome
Title Laboratory Values: Hematology Assessed at Baseline and 6 Months.
Hide Description Comparing Lab values and differences from Baseline to month 6
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: thousands/microliter
WBC - Baseline 6898.49  (1991.34) 6336.93  (1815.00)
WBC - Month 6 6463.61  (1421.58) 6387.03  (1828.81)
Neutrophils - Baseline 53.46  (9.17) 53.52  (8.63)
Neutrophils - Month 6 52.47  (8.46) 52.90  (8.51)
Lymphocytes - Baseline 35.96  (8.03) 35.87  (8.28)
Lymphocytes - Month 6 36.96  (7.61) 36.03  (8.19)
Monocytes - Baseline 7.03  (1.64) 7.03  (1.80)
Monocytes - Month 6 7.08  (1.39) 7.14  (1.75)
Eosinophils - Baseline 2.81  (2.34) 2.69  (1.71)
Eosinophils - Month 6 2.75  (2.08) 2.99  (2.21)
Basophils - Baseline 0.48  (0.28) 0.52  (0.28)
Basophils - Month 6 0.50  (0.21) 0.51  (0.26)
Platelets - Baseline 249.63  (52.79) 250.19  (53.67)
Platelets - Month 6 243.69  (46.03) 240.26  (50.90)
Hemoglobin (%)- Baseline 15.44  (1.17) 15.54  (0.88)
Hemoglobin (%) - Month 6 15.41  (1.10) 15.46  (0.86)
MCV (fL)- Baseline 92.12  (3.31) 91.89  (4.06)
MCV (fL) - Month 6 91.57  (3.51) 91.44  (3.88)
19.Secondary Outcome
Title Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.
Hide Description sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL)
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: IU/L
AST(SGOT) - Baseline 23.10  (6.77) 22.80  (6.14)
AST(SGOT) - Month 6 25.88  (10.55) 25.11  (9.51)
ALT(SGPT) - Baseline 29.79  (15.11) 26.91  (12.36)
ALT(SGPT) - Month 6 34.00  (25.79) 30.47  (18.81)
Alkaline Phosphatase - Baseline 87.34  (40.14) 85.79  (46.15)
Alkaline Phosphatase - Month 6 85.51  (33.09) 84.24  (42.44)
Bilirubin (mg/dL) - Baseline 0.78  (0.32) 0.71  (0.28)
Bilirubin (mg/dL) - Month 6 0.80  (0.32) 0.79  (0.31)
Albumin (g/dL) - Baseline 4.66  (0.22) 4.60  (0.25)
Albumin (g/dL) - Month 6 4.64  (0.21) 4.60  (0.24)
20.Secondary Outcome
Title Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.
Hide Description Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)
Time Frame Baseline and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat(ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: mg/dL
Glucose - Baseline 104.48  (25.32) 101.56  (16.17)
Glucose - Month 6 104.49  (24.45) 106.31  (20.82)
Creatinine - Baseline 1.03  (0.14) 1.03  (0.14)
Creatinine - Month 6 1.05  (0.11) 1.06  (0.14)
Ferritine (ug/L) - Baseline 100.21  (55.11) 131.91  (77.74)
Ferritine (ug/L) - Month 6 109.61  (64.29) 132.36  (87.91)
Zinc (Hmol/L) - Baseline 111.19  (35.35) 112.66  (45.62)
Zinc (Hmol/L) - Month 6 118.07  (40.75) 113.87  (39.80)
21.Secondary Outcome
Title Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Sex Drive - No Problem 60 58
Sex Drive - Very Small Problem 5 5
Sex Drive - Small Problem 4 9
Sex Drive - Medium Problem 4 3
Sex Drive - Big Problem 0 0
Erection - No Problem 62 60
Erection - Very Small Problem 7 6
Erection - Small Problem 4 7
Erection - Medium Problem 0 2
Erection - Big Problem 0 0
Ejaculation - No Problem 64 63
Ejaculation - Very Small Problem 6 4
Ejaculation - Small Problem 3 7
Ejaculation - Medium Problem 0 1
Ejaculation - Big Problem 0 0
22.Secondary Outcome
Title Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Sex Drive - No Problem 63 60
Sex Drive - Very small problem 4 5
Sex Drive - Small problem 6 8
Sex Drive - Medium problem 0 1
Sex Drive - Big problem 0 0
Erection - No Problem 64 60
Erection - Very small problem 5 6
Erection - Small problem 4 7
Erection - Medium problem 0 1
Erection - Big problem 0 0
Ejaculation - No Problem 63 62
Ejaculation - Very small problem 7 5
Ejaculation - Small problem 3 7
Ejaculation - Medium problem 0 0
Ejaculation - Big problem 0 0
23.Secondary Outcome
Title Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Sex Drive - No Problem 49 59
Sex Drive - Very small Problem 12 8
Sex Drive - Small Problem 5 5
Sex Drive - Medium Problem 5 0
Sex Drive - Big Problem 0 1
Erection - No Problem 52 56
Erection - Very Small Problem 11 10
Erection - Small Problem 2 3
Erection - Medium Problem 6 3
Erection - Big Problem 0 1
Ejaculation - No Problem 55 59
Ejaculation - Very Small Problem 9 8
Ejaculation - Small Problem 3 3
Ejaculation - Medium Problem 4 2
Ejaculation - Big Problem 0 1
24.Secondary Outcome
Title Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Sex Drive - No Problem 56 59
Sex Drive - Very Small Problem 7 6
Sex Drive - Small Problem 7 8
Sex Drive - Medium Problem 2 2
Sex Drive - Big Problem 0 0
Erection - No Problem 57 58
Erection - Very Small Problem 6 9
Erection - Small Problem 6 7
Erection - Medium Problem 3 1
Erection - Big Problem 0 0
Ejaculation - No Problem 58 59
Ejaculation - Very Small Problem 8 8
Ejaculation - Small Problem 4 6
Ejaculation - Medium Problem 2 2
Ejaculation - Big Problem 0 0
25.Secondary Outcome
Title Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem?
Time Frame Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
Sex Drive - No Problem 62 62
Sex Drive - Very Small Problem 7 6
Sex Drive - Small Problem 2 4
Sex Drive - Medium Problem 1 3
Sex Drive - Big Problem 0 0
Erection - No Problem 59 60
Erection - Very Small Problem 9 11
Erection - Small Problem 4 2
Erection - Medium Problem 0 2
Erection - Big Problem 0 0
Ejaculation - No Problem 60 62
Ejaculation - Very Small Problem 7 10
Ejaculation - Small Problem 4 1
Ejaculation - Medium Problem 0 2
Ejaculation - Big Problem 1 0
26.Secondary Outcome
Title Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
No Problem shift to No Problem 53 52
No Problem shift to Very Small Problem 6 4
No Problem shift to Small Problem 2 4
No Problem shift to Medium Problem 1 0
No Problem shift to Big Problem 0 0
Very Small Problem shift to No Problem 0 4
Very Small Problem shift to Very Small Problem 0 0
Very Small Problem shift to Small Problem 3 1
Very Small Problem shift to Medium Problem 1 0
Very Small Problem shift to Big Problem 0 0
Small Problem shift to No Problem 3 1
Small Problem shift to Very Small Problem 1 2
Small Problem shift to Small Problem 2 3
Small Problem shift to Medium Problem 0 2
Small Problem shift to Big Problem 0 0
Medium Problem shift to No Problem 0 1
Medium Problem shift to Very Small Problem 0 0
Medium Problem shift to Small Problem 0 0
Medium Problem shift to Medium Problem 0 0
Medium Problem shift to Big Problem 0 0
Big Problem shift to No Problem 0 0
Big Problem shift to Very Small Problem 0 0
Big Problem shift to Small Problem 0 0
Big Problem shift to Medium Problem 0 0
Big Problem shift to Big Problem 0 0
27.Secondary Outcome
Title Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
No Problem shift to No Problem 53 52
No Problem shift to Very Small Problem 6 5
No Problem shift to Small Problem 3 3
No Problem shift to Medium Problem 1 0
No Problem shift to Big Problem 0 0
Very Small Problem shift to No Problem 2 3
Very Small Problem shift to Very Small Problem 0 3
Very Small Problem shift to Small Problem 2 0
Very Small Problem shift to Medium Problem 1 0
Very Small Problem shift to Big Problem 0 0
Small Problem shift to No Problem 2 1
Small Problem shift to Very Small Problem 0 1
Small Problem shift to Small Problem 1 4
Small Problem shift to Medium Problem 1 1
Small Problem shift to Big Problem 0 0
Medium Problem shift to No Problem 0 1
Medium Problem shift to Very Small Problem 0 0
Medium Problem shift to Small Problem 0 0
Medium Problem shift to Medium Problem 0 0
Medium Problem shift to Big Problem 0 0
Big Problem shift to No Problem 0 0
Big Problem shift to Very Small Problem 0 0
Big Problem shift to Small Problem 0 0
Big Problem shift to Medium Problem 0 0
Big Problem shift to Big Problem 0 0
28.Secondary Outcome
Title Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
No Problem shift to No Problem 54 54
No Problem shift to Very Small Problem 5 5
No Problem shift to Small Problem 2 3
No Problem shift to Medium Problem 1 0
No Problem shift to Big Problem 0 0
Very Small Problem shift to No Problem 3 3
Very Small Problem shift to Very Small Problem 3 1
Very Small Problem shift to Small Problem 1 0
Very Small Problem shift to Medium Problem 0 1
Very Small Problem shift to Big Problem 0 0
Small Problem shift to No Problem 1 1
Small Problem shift to Very Small Problem 0 2
Small Problem shift to Small Problem 1 3
Small Problem shift to Medium Problem 1 1
Small Problem shift to Big Problem 0 0
Medium Problem shift to No Problem 0 0
Medium Problem shift to Very Small Problem 0 0
Medium Problem shift to Small Problem 0 0
Medium Problem shift to Medium Problem 0 0
Medium Problem shift to Big Problem 0 0
Big Problem shift to No Problem 0 0
Big Problem shift to Very Small Problem 0 0
Big Problem shift to Small Problem 0 0
Big Problem shift to Medium Problem 0 0
Big Problem shift to Big Problem 0 0
29.Secondary Outcome
Title Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time Frame Baseline to Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
No Problem shift to No Problem 57 55
No Problem shift to Very Small Problem 5 3
No Problem shift to Small Problem 0 0
No Problem shift to Medium Problem 0 2
No Problem shift to Big Problem 0 0
Very Small Problem shift to No Problem 2 4
Very Small Problem shift to Very Small Problem 1 0
Very Small Problem shift to Small Problem 1 1
Very Small Problem shift to Medium Problem 0 0
Very Small Problem shift to Big Problem 0 0
Small Problem shift to No Problem 3 1
Small Problem shift to Very Small Problem 1 3
Small Problem shift to Small Problem 1 3
Small Problem shift to Medium Problem 1 1
Small Problem shift to Big Problem 0 0
Medium Problem shift to No Problem 0 1
Medium Problem shift to Very Small Problem 0 0
Medium Problem shift to Small Problem 0 0
Medium Problem shift to Medium Problem 0 0
Medium Problem shift to Big Problem 0 0
Big Problem shift to No Problem 0 0
Big Problem shift to Very Small Problem 0 0
Big Problem shift to Small Problem 0 0
Big Problem shift to Medium Problem 0 0
Big Problem shift to Big Problem 0 0
30.Secondary Outcome
Title Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time Frame Baseline to Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
No Problem shift to No Problem 54 54
No Problem shift to Very Small Problem 6 5
No Problem shift to Small Problem 3 0
No Problem shift to Medium Problem 0 1
No Problem shift to Big Problem 0 0
Very Small Problem shift to No Problem 2 2
Very Small Problem shift to Very Small Problem 3 4
Very Small Problem shift to Small Problem 0 0
Very Small Problem shift to Medium Problem 0 0
Very Small Problem shift to Big Problem 0 0
Small Problem shift to No Problem 3 2
Small Problem shift to Very Small Problem 0 2
Small Problem shift to Small Problem 1 2
Small Problem shift to Medium Problem 0 1
Small Problem shift to Big Problem 0 0
Medium Problem shift to No Problem 0 1
Medium Problem shift to Very Small Problem 0 0
Medium Problem shift to Small Problem 0 0
Medium Problem shift to Medium Problem 0 0
Medium Problem shift to Big Problem 0 0
Big Problem shift to No Problem 0 0
Big Problem shift to Very Small Problem 0 0
Big Problem shift to Small Problem 0 0
Big Problem shift to Medium Problem 0 0
Big Problem shift to Big Problem 0 0
31.Secondary Outcome
Title Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation
Hide Description In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively.
Time Frame Baseline to Month 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
Subjects who were given no Investigational product.
Overall Number of Participants Analyzed 73 75
Measure Type: Number
Unit of Measure: Participants
No Problem shift to No Problem 56 56
No Problem shift to Very Small problem 2 6
No Problem shift to Small Problem 3 0
No Problem shift to Medium Problem 0 0
No Problem shift to Big Problem 1 0
Very Small Problem shift to No Problem 2 3
Very Small Problem shift to Very Small Problem 5 1
Very Small Problem shift to Small Problem 0 0
Very Small Problem shift to Medium Problem 0 1
Very Small Problem shift to Big Problem 0 0
Small Problem shift to No Problem 2 2
Small Problem shift to Very Small Problem 0 3
Small Problem shift to Small Problem 1 1
Small Problem shift to Medium Problem 0 1
Small Problem shift to Big Problem 0 0
Medium Problem shift to No Problem 0 0
Medium Problem shift to Very Small Problem 0 0
Medium Problem shift to Small Problem 0 0
Medium Problem shift to Medium Problem 0 0
Medium Problem shift to Big Problem 0 0
Big Problem shift to No Proble 0 0
Big Problem shift to Very Small Problem 0 0
Big Problem shift to Small Problem 0 0
Big Problem shift to Medium Problem 0 0
Big Problem shift to Big Problem 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. Subjects who were given no Investigational product.
All-Cause Mortality
Dutasteride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      1    
Endocrine disorders     
Thyroid Cancer  1  0/73 (0.00%)  0 1/75 (1.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dutasteride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/73 (16.44%)      7/75 (9.33%)    
Respiratory, thoracic and mediastinal disorders     
Nasopharyngitis  1  12/73 (16.44%)  7/75 (9.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 no prohibit any investigator form 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
ClinicalTrials.gov Identifier: NCT00441116     History of Changes
Other Study ID Numbers: 106377
First Submitted: February 27, 2007
First Posted: February 28, 2007
Results First Submitted: January 20, 2009
Results First Posted: April 22, 2009
Last Update Posted: August 16, 2018