Trial Outcomes & Findings for Prospective Sexual Function Study for BPH Subjects (NCT NCT01777269)
NCT ID: NCT01777269
Last Updated: 2018-08-20
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
489 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2018-08-20
Participant Flow
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)
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
Participant milestones
| Measure |
Placebo
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
243
|
|
Overall Study
COMPLETED
|
191
|
184
|
|
Overall Study
NOT COMPLETED
|
55
|
59
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
Participants received a combination of dutasteride 0.5 milligrams (mg) and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
24
|
33
|
|
Overall Study
Lack of Efficacy
|
8
|
10
|
|
Overall Study
Protocol Violation
|
4
|
4
|
|
Overall Study
Participants reached stopping criteria
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Physician Decision
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
9
|
Baseline Characteristics
Prospective Sexual Function Study for BPH Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
Total
n=489 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 6.49 • n=93 Participants
|
65.7 Years
STANDARD_DEVIATION 6.59 • n=4 Participants
|
65.5 Years
STANDARD_DEVIATION 6.53 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
246 Participants
n=93 Participants
|
243 Participants
n=4 Participants
|
489 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
239 Participants
n=93 Participants
|
237 Participants
n=4 Participants
|
476 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: 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).
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)
Outcome measures
| Measure |
Placebo
n=162 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=151 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months
|
-0.7 Scores on a scale
Standard Error 0.78
|
-8.7 Scores on a scale
Standard Error 0.81
|
SECONDARY outcome
Timeframe: Baseline and Month 1, 3, 6, and 9Population: ITT Population
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)
Outcome measures
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
Month 1, n=193, 192
|
-0.5 Scores on a scale
Standard Error 0.68
|
-4.6 Scores on a scale
Standard Error 0.69
|
|
Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
Month 3, n= 184, 181
|
-0.5 Scores on a scale
Standard Error 0.72
|
-6.9 Scores on a scale
Standard Error 0.73
|
|
Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
Month 6, n=179, 164
|
-0.8 Scores on a scale
Standard Error 0.80
|
-9.9 Scores on a scale
Standard Error 0.83
|
|
Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
Month 9, n=166, 146
|
-0.8 Scores on a scale
Standard Error 0.76
|
-9.6 Scores on a scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).
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
Outcome measures
| Measure |
Placebo
n=162 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=151 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
>= 25
|
0 Participants
|
1 Participants
|
|
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
>= 20
|
3 Participants
|
3 Participants
|
|
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
>= 10
|
16 Participants
|
8 Participants
|
|
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
<= -25
|
3 Participants
|
13 Participants
|
|
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
<= -20
|
3 Participants
|
20 Participants
|
|
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
<= -10
|
24 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 1, 3, 6, 9 and 12Population: ITT Population
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)
Outcome measures
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
Month 1, n=209, 215
|
-0.3 Scores on a scale
Standard Error 0.15
|
-0.5 Scores on a scale
Standard Error 0.15
|
|
Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
Month 3, n= 202, 208
|
-0.5 Scores on a scale
Standard Error 0.17
|
-0.7 Scores on a scale
Standard Error 0.17
|
|
Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
Month 6, n= 193, 188
|
-0.6 Scores on a scale
Standard Error 0.18
|
-1.0 Scores on a scale
Standard Error 0.19
|
|
Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
Month 9, n=182, 169
|
-0.5 Scores on a scale
Standard Error 0.18
|
-1.2 Scores on a scale
Standard Error 0.19
|
|
Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
Month 12, n= 175, 168
|
-0.5 Scores on a scale
Standard Error 0.19
|
-1.0 Scores on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline and Month 1, 3, 6, 9 and 12Population: ITT Population
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)
Outcome measures
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
Month 1, n=210, 208
|
-0.3 Scores on a scale
Standard Error 0.42
|
-3.2 Scores on a scale
Standard Error 0.43
|
|
Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
Month 3, n= 197, 196
|
-0.5 Scores on a scale
Standard Error 0.48
|
-5.8 Scores on a scale
Standard Error 0.48
|
|
Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
Month 6, n= 191, 179
|
-0.7 Scores on a scale
Standard Error 0.53
|
-7.5 Scores on a scale
Standard Error 0.54
|
|
Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
Month 9, n=177, 161
|
-0.5 Scores on a scale
Standard Error 0.52
|
-7.6 Scores on a scale
Standard Error 0.53
|
|
Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
Month 12, n= 173, 164
|
-0.6 Scores on a scale
Standard Error 0.55
|
-7.5 Scores on a scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline and Month 1, 3, 6, 9 and 12Population: ITT Population
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)
Outcome measures
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
Month 1, n=200, 197
|
0.1 Scores on a scale
Standard Deviation 0.26
|
-0.8 Scores on a scale
Standard Deviation 0.26
|
|
Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
Month 3, n= 189, 182
|
0.4 Scores on a scale
Standard Deviation 0.27
|
-0.5 Scores on a scale
Standard Deviation 0.28
|
|
Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
Month 6, n= 185, 168
|
0.2 Scores on a scale
Standard Deviation 0.30
|
-1.5 Scores on a scale
Standard Deviation 0.31
|
|
Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
Month 9, n=173, 153
|
-0.0 Scores on a scale
Standard Deviation 0.30
|
-1.2 Scores on a scale
Standard Deviation 0.32
|
|
Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
Month 12, n= 169, 152
|
0.3 Scores on a scale
Standard Deviation 0.29
|
-0.6 Scores on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline and Month 1, 3, 6, 9 and 12Population: ITT Population
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)
Outcome measures
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
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
Week 2, n=232, 234
|
-1.5 Scores on a scale
Standard Error 0.29
|
-3.1 Scores on a scale
Standard Error 0.29
|
|
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
Month1, n=222, 231
|
-2.8 Scores on a scale
Standard Error 0.33
|
-3.4 Scores on a scale
Standard Error 0.33
|
|
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
Month 3, n=217, 224
|
-2.8 Scores on a scale
Standard Error 0.33
|
-4.1 Scores on a scale
Standard Error 0.33
|
|
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
Month 6, n=206, 203
|
-2.9 Scores on a scale
Standard Error 0.36
|
-4.6 Scores on a scale
Standard Error 0.36
|
|
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
Month 9, n=193, 185
|
-3.2 Scores on a scale
Standard Error 0.38
|
-4.5 Scores on a scale
Standard Error 0.38
|
|
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
Month 12, n=187, 184
|
-3.2 Scores on a scale
Standard Error 0.41
|
-5.2 Scores on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline and Month 1, 3, 6, 9 and 12Population: ITT Population
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)
Outcome measures
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Week 2, n=226, 227
|
-0.3 Scores on a scale
Standard Error 0.14
|
-0.7 Scores on a scale
Standard Error 0.14
|
|
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Month1, n=216, 223
|
-0.7 Scores on a scale
Standard Error 0.13
|
-0.7 Scores on a scale
Standard Error 0.13
|
|
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Month 3, n=211, 217
|
-0.9 Scores on a scale
Standard Error 0.15
|
-1.1 Scores on a scale
Standard Error 0.15
|
|
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Month 6, n=201, 195
|
-0.6 Scores on a scale
Standard Error 0.17
|
-1.2 Scores on a scale
Standard Error 0.17
|
|
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Month 9, n=188, 179
|
-0.7 Scores on a scale
Standard Error 0.16
|
-1.2 Scores on a scale
Standard Error 0.17
|
|
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
Month 12, n=183, 177
|
-0.6 Scores on a scale
Standard Error 0.18
|
-1.2 Scores on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 3, 6, 9 and 12Population: ITT Population
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)
Outcome measures
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
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
Week 2, n=225, 227
|
-0.4 Scores on a scale
Standard Error 0.32
|
-3.4 Scores on a scale
Standard Error 0.32
|
|
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
Month1, n=216, 223
|
-1.3 Scores on a scale
Standard Error 0.38
|
-3.4 Scores on a scale
Standard Error 0.38
|
|
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
Month 3, n=211, 217
|
-1.7 Scores on a scale
Standard Error 0.41
|
-3.8 Scores on a scale
Standard Error 0.41
|
|
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
Month 6, n=201, 195
|
-1.0 Scores on a scale
Standard Error 0.44
|
-3.6 Scores on a scale
Standard Error 0.44
|
|
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
Month 9, n=188, 179
|
-1.6 Scores on a scale
Standard Error 0.45
|
-2.9 Scores on a scale
Standard Error 0.45
|
|
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
Month 12, n=182, 177
|
-1.0 Scores on a scale
Standard Error 0.49
|
-4.6 Scores on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: ITT Population
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)
Outcome measures
| Measure |
Placebo
n=246 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points
IPSS improvement of >=2, n=152, 142
|
-0.6 Scores on a scale
Standard Error 0.81
|
-8.4 Scores on a scale
Standard Error 0.83
|
|
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points
IPSS improvement of >=3, n=138,136
|
-0.6 Scores on a scale
Standard Error 0.86
|
-8.0 Scores on a scale
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
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)
Outcome measures
| Measure |
Placebo
n=139 Participants
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=133 Participants
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent
|
-0.6 Scores on a scale
Standard Error 0.86
|
-8.3 Scores on a scale
Standard Error 0.88
|
Adverse Events
Placebo
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Duodart
Serious events: 27 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=246 participants at risk
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 participants at risk
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.82%
2/243 • Number of events 2 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.82%
2/243 • Number of events 3 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Infections and infestations
Cystitis
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Infections and infestations
Meningitis
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Cardiac failure
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Atrial flutter
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Left ventricular failure
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.82%
2/243 • Number of events 2 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Nervous system disorders
Cerebrospinal fistula
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Renal and urinary disorders
Urinary retention
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.00%
0/243 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.41%
1/246 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.00%
0/246 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
0.41%
1/243 • Number of events 1 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
Other adverse events
| Measure |
Placebo
n=246 participants at risk
Participants received a matching placebo for Duodart plus lifestyle advice for 12 months
|
Duodart
n=243 participants at risk
Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months
|
|---|---|---|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.5%
16/246 • Number of events 17 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
9.9%
24/243 • Number of events 25 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Reproductive system and breast disorders
Retrograde ejaculation
|
1.2%
3/246 • Number of events 3 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
9.5%
23/243 • Number of events 23 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.81%
2/246 • Number of events 2 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
6.6%
16/243 • Number of events 16 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
|
Psychiatric disorders
Libido decreased
|
4.9%
12/246 • Number of events 12 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
8.2%
20/243 • Number of events 22 • 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).
On-treatment SAEs and non-serious AEs are reported for ITT Population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER