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Prospective Sexual Function Study for BPH Subjects

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: NCT01777269
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : July 14, 2017
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostatic Hyperplasia
Interventions Drug: Dutasteride plus tamsulosin
Drug: Placebo
Enrollment 489
Recruitment Details This is a European double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function in men with moderate/severe Benign Prostatic Hyperplasia (BPH)
Pre-assignment Details Eligible participants (par.) entered a 4-week Placebo Run-in Phase, and were randomised in 1:1 ratio to receive DUODART (fixed dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg) and placebo one capsule daily for 52 weeks. Follow-up was performed 6 months after the last dose of study medication
Arm/Group Title Placebo Duodart
Hide Arm/Group Description Participants received a matching placebo for Duodart plus lifestyle advice for 12 months Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Period Title: Overall Study
Started 246 243
Completed 191 184
Not Completed 55 59
Reason Not Completed
Adverse Event             24             33
Lack of Efficacy             8             10
Protocol Violation             4             4
Participants reached stopping criteria             1             1
Lost to Follow-up             4             0
Physician Decision             5             2
Withdrawal by Subject             9             9
Arm/Group Title Placebo Duodart Total
Hide Arm/Group Description Participants received a matching placebo for Duodart plus lifestyle advice for 12 months Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months Total of all reporting groups
Overall Number of Baseline Participants 246 243 489
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 246 participants 243 participants 489 participants
65.4  (6.49) 65.7  (6.59) 65.5  (6.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 243 participants 489 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
246
 100.0%
243
 100.0%
489
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 246 participants 243 participants 489 participants
African American/African Heritage 1 2 3
American Indian or Alaska Native 2 3 5
Asian - East Asian Heritage 1 0 1
White - Arabic/North African Heritage 3 0 3
White - White/Caucasian/European Heritage 239 237 476
Mixed Race 0 1 1
1.Primary Outcome
Title Changes From Baseline (BL) in Total Score From the Full Men’s Sexual Health Questionnaire (MSHQ) at 12 Months
Hide Description Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): All randomized par. regardless of whether or not treatment was administered. Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 162 151
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.7  (0.78) -8.7  (0.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -8.00
Confidence Interval (2-Sided) 95%
-10.22 to -5.79
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Scores From the Full Men’s Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
Hide Description Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline and Month 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 246 243
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Month 1, n=193, 192 -0.5  (0.68) -4.6  (0.69)
Month 3, n= 184, 181 -0.5  (0.72) -6.9  (0.73)
Month 6, n=179, 164 -0.8  (0.80) -9.9  (0.83)
Month 9, n=166, 146 -0.8  (0.76) -9.6  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -4.11
Confidence Interval (2-Sided) 95%
-6.01 to -2.21
Estimation Comments Month 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Adjusted mean difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -6.43
Confidence Interval (2-Sided) 95%
-8.45 to -4.41
Estimation Comments Month 3
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -9.04
Confidence Interval (2-Sided) 95%
-11.31 to -6.77
Estimation Comments Month 6
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -8.82
Confidence Interval (2-Sided) 95%
-10.96 to -6.67
Estimation Comments Month 9
3.Secondary Outcome
Title Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
Hide Description Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where “+” indicates improvement and “-”indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 162 151
Measure Type: Number
Unit of Measure: Participants
>= 25 0 1
>= 20 3 3
>= 10 16 8
<= -25 3 13
<= -20 3 20
<= -10 24 61
4.Secondary Outcome
Title Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
Hide Description Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline and Month 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 246 243
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Month 1, n=209, 215 -0.3  (0.15) -0.5  (0.15)
Month 3, n= 202, 208 -0.5  (0.17) -0.7  (0.17)
Month 6, n= 193, 188 -0.6  (0.18) -1.0  (0.19)
Month 9, n=182, 169 -0.5  (0.18) -1.2  (0.19)
Month 12, n= 175, 168 -0.5  (0.19) -1.0  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.62 to 0.23
Estimation Comments Month 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
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 mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.71 to 0.24
Estimation Comments Month 3
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.88 to 0.15
Estimation Comments Month 6
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.19 to -0.17
Estimation Comments Month 9
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.99 to 0.07
Estimation Comments Month 12
5.Secondary Outcome
Title Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
Hide Description Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline and Month 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 246 243
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Month 1, n=210, 208 -0.3  (0.42) -3.2  (0.43)
Month 3, n= 197, 196 -0.5  (0.48) -5.8  (0.48)
Month 6, n= 191, 179 -0.7  (0.53) -7.5  (0.54)
Month 9, n=177, 161 -0.5  (0.52) -7.6  (0.53)
Month 12, n= 173, 164 -0.6  (0.55) -7.5  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.89
Confidence Interval (2-Sided) 95%
-4.07 to -1.70
Estimation Comments Month 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -5.24
Confidence Interval (2-Sided) 95%
-6.59 to -3.90
Estimation Comments Month 3
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -6.82
Confidence Interval (2-Sided) 95%
-8.30 to -5.34
Estimation Comments Month 6
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -7.05
Confidence Interval (2-Sided) 95%
-8.51 to -5.59
Estimation Comments Month 9
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -6.92
Confidence Interval (2-Sided) 95%
-8.47 to -5.38
Estimation Comments Month 12
6.Secondary Outcome
Title Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
Hide Description Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline and Month 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 246 243
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Month 1, n=200, 197 0.1  (0.26) -0.8  (0.26)
Month 3, n= 189, 182 0.4  (0.27) -0.5  (0.28)
Month 6, n= 185, 168 0.2  (0.30) -1.5  (0.31)
Month 9, n=173, 153 -0.0  (0.30) -1.2  (0.32)
Month 12, n= 169, 152 0.3  (0.29) -0.6  (0.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-1.67 to -0.21
Estimation Comments Month 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.93
Confidence Interval (2-Sided) 95%
-1.69 to -0.17
Estimation Comments Month 3
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-2.57 to -0.88
Estimation Comments Month 6
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.15
Confidence Interval (2-Sided) 95%
-2.01 to -0.30
Estimation Comments Month 9
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-1.65 to -0.01
Estimation Comments Month 12
7.Secondary Outcome
Title Change From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months
Hide Description The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline and Month 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 246 243
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 2, n=232, 234 -1.5  (0.29) -3.1  (0.29)
Month1, n=222, 231 -2.8  (0.33) -3.4  (0.33)
Month 3, n=217, 224 -2.8  (0.33) -4.1  (0.33)
Month 6, n=206, 203 -2.9  (0.36) -4.6  (0.36)
Month 9, n=193, 185 -3.2  (0.38) -4.5  (0.38)
Month 12, n=187, 184 -3.2  (0.41) -5.2  (0.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.65
Confidence Interval (2-Sided) 95%
-2.45 to -0.85
Estimation Comments Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.55
Confidence Interval (2-Sided) 95%
-1.47 to 0.37
Estimation Comments Month 1
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-2.19 to -0.36
Estimation Comments Month 3
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.73
Confidence Interval (2-Sided) 95%
-2.74 to -0.72
Estimation Comments Month 6
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.34
Confidence Interval (2-Sided) 95%
-2.40 to -0.28
Estimation Comments Month 9
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.97
Confidence Interval (2-Sided) 95%
-3.12 to -0.83
Estimation Comments Month 12
8.Secondary Outcome
Title Change From Baseline in Quality of Life (BPH Impact Index –BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Hide Description The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline and Month 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 246 243
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 2, n=226, 227 -0.3  (0.14) -0.7  (0.14)
Month1, n=216, 223 -0.7  (0.13) -0.7  (0.13)
Month 3, n=211, 217 -0.9  (0.15) -1.1  (0.15)
Month 6, n=201, 195 -0.6  (0.17) -1.2  (0.17)
Month 9, n=188, 179 -0.7  (0.16) -1.2  (0.17)
Month 12, n=183, 177 -0.6  (0.18) -1.2  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.78 to -0.03
Estimation Comments Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
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 mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.37 to 0.37
Estimation Comments Month 1
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.67 to 0.15
Estimation Comments Month 3
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.09 to -0.15
Estimation Comments Month 6
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.91 to 0.01
Estimation Comments Month 9
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-1.08 to -0.08
Estimation Comments Month 12
9.Secondary Outcome
Title Change From Baseline in Perception of Treatment Benefit/Satisfaction With Treatment (Patient Perception of Study Medication - PPSM Questionnaire Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Hide Description Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline, Week 2, Month 1, 3, 6, 9 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 246 243
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 2, n=225, 227 -0.4  (0.32) -3.4  (0.32)
Month1, n=216, 223 -1.3  (0.38) -3.4  (0.38)
Month 3, n=211, 217 -1.7  (0.41) -3.8  (0.41)
Month 6, n=201, 195 -1.0  (0.44) -3.6  (0.44)
Month 9, n=188, 179 -1.6  (0.45) -2.9  (0.45)
Month 12, n=182, 177 -1.0  (0.49) -4.6  (0.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.00
Confidence Interval (2-Sided) 95%
-3.89 to -2.10
Estimation Comments Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.10
Confidence Interval (2-Sided) 95%
-3.15 to -1.06
Estimation Comments Month 1
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.11
Confidence Interval (2-Sided) 95%
-3.25 to -0.98
Estimation Comments Month 3
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -2.53
Confidence Interval (2-Sided) 95%
-3.76 to -1.30
Estimation Comments Month 6
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -1.30
Confidence Interval (2-Sided) 95%
-2.56 to -0.05
Estimation Comments Month 9
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -3.51
Confidence Interval (2-Sided) 95%
-4.87 to -2.14
Estimation Comments Month 12
10.Secondary Outcome
Title Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points
Hide Description Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 246 243
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
IPSS improvement of >=2, n=152, 142 -0.6  (0.81) -8.4  (0.83)
IPSS improvement of >=3, n=138,136 -0.6  (0.86) -8.0  (0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -7.78
Confidence Interval (2-Sided) 95%
-10.07 to -5.49
Estimation Comments Par. with IPSS change from baseline >=2 points improvement at any time post-baseline visit
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -7.39
Confidence Interval (2-Sided) 95%
-9.79 to -4.99
Estimation Comments Par. with IPSS change from baseline >=3 points improvement at any time post-baseline visit
11.Secondary Outcome
Title Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent
Hide Description Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
Arm/Group Title Placebo Duodart
Hide Arm/Group Description:
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
Overall Number of Participants Analyzed 139 133
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.6  (0.86) -8.3  (0.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Duodart
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-model repeated-measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -7.79
Confidence Interval (2-Sided) 95%
-10.22 to -5.35
Estimation Comments Par. with IPSS change from baseline >=25 points improvement at any time post-baseline visit
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 approximately 18 months).
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs are reported for ITT Population.
 
Arm/Group Title Placebo Duodart
Hide Arm/Group Description Participants received a matching placebo for Duodart plus lifestyle advice for 12 months Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
All-Cause Mortality
Placebo Duodart
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Duodart
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/246 (3.66%)      27/243 (11.11%)    
Cardiac disorders     
Cardiac failure  1  1/246 (0.41%)  1 1/243 (0.41%)  1
Acute myocardial infarction  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Angina pectoris  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Aortic valve incompetence  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Atrial fibrillation  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Atrial flutter  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Left ventricular failure  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Ventricular arrhythmia  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Acute coronary syndrome  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Constipation  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Diarrhoea  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Inguinal hernia  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Large intestine polyp  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Abdominal hernia  1  0/246 (0.00%)  0 1/243 (0.41%)  1
General disorders     
Non-cardiac chest pain  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Hepatobiliary disorders     
Cholecystitis  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Cholelithiasis  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Hypertransaminasaemia  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Infections and infestations     
Pneumonia  1  0/246 (0.00%)  0 2/243 (0.82%)  2
Urinary tract infection  1  0/246 (0.00%)  0 2/243 (0.82%)  3
Cystitis  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Meningitis  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Postoperative wound infection  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Infected cyst  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Respiratory tract infection  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Injury, poisoning and procedural complications     
Joint dislocation  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Meniscus injury  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Metabolism and nutrition disorders     
Hypokalaemia  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Hyponatraemia  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Hypovolaemia  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Musculoskeletal and connective tissue disorders     
Spinal column stenosis  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Gastric cancer  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Pancreatic carcinoma  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Prostatic adenoma  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Renal cancer  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Lung cancer metastatic  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Abdominal neoplasm  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Pituitary tumour benign  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Nervous system disorders     
Presyncope  1  0/246 (0.00%)  0 2/243 (0.82%)  2
Cerebrovascular accident  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Syncope  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Cerebrospinal fistula  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Ischaemic stroke  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Thalamic infarction  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Psychiatric disorders     
Delirium  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Renal and urinary disorders     
Nephrolithiasis  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Pelvi-ureteric obstruction  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Urinary retention  1  1/246 (0.41%)  1 0/243 (0.00%)  0
Reproductive system and breast disorders     
Testicular cyst  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/246 (0.41%)  1 1/243 (0.41%)  1
Vascular disorders     
Thrombosis  1  0/246 (0.00%)  0 1/243 (0.41%)  1
Varicose vein  1  0/246 (0.00%)  0 1/243 (0.41%)  1
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 Duodart
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/246 (11.38%)      66/243 (27.16%)    
Psychiatric disorders     
Libido decreased  1  12/246 (4.88%)  12 20/243 (8.23%)  22
Reproductive system and breast disorders     
Erectile dysfunction  1  16/246 (6.50%)  17 24/243 (9.88%)  25
Retrograde ejaculation  1  3/246 (1.22%)  3 23/243 (9.47%)  23
Ejaculation disorder  1  2/246 (0.81%)  2 16/243 (6.58%)  16
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
ClinicalTrials.gov Identifier: NCT01777269     History of Changes
Other Study ID Numbers: 116115
2012-002047-26 ( EudraCT Number )
First Submitted: January 24, 2013
First Posted: January 28, 2013
Results First Submitted: November 15, 2016
Results First Posted: July 14, 2017
Last Update Posted: August 20, 2018