Prostatic Hyperplasia
Conditions
Brief summary
This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo. PRIMARY OBJECTIVE: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with DUODART, compared to men treated with placebo .
Detailed description
This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo. Men eligible at screening will be randomised, after a 4 week placebo run-in, to the 2 treatment groups in a 1:1 ratio. All men will receive standardised lifestyle advice (primarily concerning weight management and exercise) relevant to maintaining sexual function. Men will also receive a standardised lifestyle advice leaflet for BPH. The double blind phase will continue for 12 months, with assessment visits at 2 weeks and at months 1, 3, 6, 9 and a final visit at month 12. Subjects with sexual adverse events during the double blind phase will continue to be followed at scheduled study visits until resolution of the adverse event or at a visit 6 months after the last dose of study medication, whichever is sooner. PRIMARY OBJECTIVE: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH (international prostate symptom score - IPSS = or \> 12) who are treated with DUODART, compared to men treated with placebo . Change in sexual function will be assessed by change in total score from the full men's sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido.
Interventions
Take 1 capsule daily
DRUGPlacebo
Take one capsule daily
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males aged ≥50 years. * Men must be sexually active. A man is considered sexually active if he has been engaged in sexual activity with a partner during the past 4 weeks (at least once) and plans to be active during the next 4 weeks (unless due to travel or other practical reasons). Men should confirm that they are in a stable relationship and expect to maintain their sexual activity over the next year. * A confirmed clinical diagnosis of BPH. * International Prostate Symptom Score (IPSS) ≥12 at Visit 1 (screening), with bother score 4 or less (score from the IPSS Quality of Life question 8). * Prostate volume ≥30 cc (by transrectal ultrasonography; TRUS). Measurement should be available by the baseline visit and should have been made /arranged at the screening visit or within the previous 6 months. * Total serum prostate specific antigen (PSA ≥1.5 ng/mL (see
Exclusion criteria
1) at Visit 1 (screening). * Willing and able to give signed written informed consent and comply with study procedures, including the ability to participate in the study for the full 1 year (or 18 months if necessary because of a persistent sexual AE). * Fluent and literate in local language with the ability to read, comprehend and record information on the MSHQ, IPSS, PPSM, BPH Impact Index (BII) and C-SSRS questionnaires. * Able to swallow and retain oral medication. * Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug (45 days) plus 3 months (i.e. a total of 4.5 months) to allow clearance of any altered sperm after the last dose of study treatment. * French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months | Baseline and 12 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | Baseline and 12 months | 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 |
| Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months | Baseline and Month 1, 3, 6, 9 and 12 | 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) |
| Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months | Baseline and Month 1, 3, 6, 9 and 12 | 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) |
| Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months | Baseline and Month 1, 3, 6, 9 and 12 | 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) |
| Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months | Baseline and Month 1, 3, 6, and 9 | 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) |
| Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months | Baseline and Month 1, 3, 6, 9 and 12 | 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) |
| 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 | Baseline, Week 2, Month 1, 3, 6, 9 and 12 | 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) |
| Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points | Baseline and Month 12 | 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) |
| Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent | Baseline and Month 12 | 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) |
| 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 | Baseline and Month 1, 3, 6, 9 and 12 | 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) |
Countries
Australia, France, Germany, Greece, Hungary, Netherlands, Spain
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a matching placebo for Duodart plus lifestyle advice for 12 months | 246 |
| Duodart Participants received a combination of dutasteride 0.5 mg and tamsulosin 0.4 mg plus lifestyle advice for 12 months | 243 |
| Total | 489 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 24 | 33 |
| Overall Study | Lack of Efficacy | 8 | 10 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Participants reached stopping criteria | 1 | 1 |
| Overall Study | Physician Decision | 5 | 2 |
| Overall Study | Protocol Violation | 4 | 4 |
| Overall Study | Withdrawal by Subject | 9 | 9 |
Baseline characteristics
| Characteristic | Duodart | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 65.7 Years STANDARD_DEVIATION 6.59 | 65.5 Years STANDARD_DEVIATION 6.53 | 65.4 Years STANDARD_DEVIATION 6.49 |
| Race/Ethnicity, Customized African American/African Heritage | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed Race | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 237 Participants | 476 Participants | 239 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 243 Participants | 489 Participants | 246 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 246 | 66 / 243 |
| serious Total, serious adverse events | 9 / 246 | 27 / 243 |
Outcome results
Primary
Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Duodart | Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months | -8.7 Scores on a scale | Standard Error 0.81 |
p-value: <0.00195% CI: [-10.22, -5.79]mixed-model repeated-measures
Secondary
Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months
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
Population: ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Duodart | Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months | Month 12, n= 173, 164 | -7.5 Scores on a scale | Standard Error 0.56 |
| Duodart | Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months | Month 3, n= 197, 196 | -5.8 Scores on a scale | Standard Error 0.48 |
| Duodart | Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months | Month 6, n= 191, 179 | -7.5 Scores on a scale | Standard Error 0.54 |
| Duodart | Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months | Month 9, n=177, 161 | -7.6 Scores on a scale | Standard Error 0.53 |
| Duodart | Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months | Month 1, n=210, 208 | -3.2 Scores on a scale | Standard Error 0.43 |
p-value: <0.00195% CI: [-4.07, -1.7]mixed-model repeated-measures
p-value: <0.00195% CI: [-6.59, -3.9]mixed-model repeated-measures
p-value: <0.00195% CI: [-8.3, -5.34]mixed-model repeated-measures
p-value: <0.00195% CI: [-8.51, -5.59]mixed-model repeated-measures
p-value: <0.00195% CI: [-8.47, -5.38]mixed-model repeated-measures
Secondary
Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months
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
Population: ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Duodart | Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months | Month 9, n=182, 169 | -1.2 Scores on a scale | Standard Error 0.19 |
| Duodart | Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months | Month 1, n=209, 215 | -0.5 Scores on a scale | Standard Error 0.15 |
| Duodart | Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months | Month 6, n= 193, 188 | -1.0 Scores on a scale | Standard Error 0.19 |
| Duodart | Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months | Month 12, n= 175, 168 | -1.0 Scores on a scale | Standard Error 0.19 |
| Duodart | Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months | Month 3, n= 202, 208 | -0.7 Scores on a scale | Standard Error 0.17 |
p-value: 0.3795% CI: [-0.62, 0.23]mixed-model repeated-measures
p-value: 0.3395% CI: [-0.71, 0.24]mixed-model repeated-measures
p-value: 0.1695% CI: [-0.88, 0.15]mixed-model repeated-measures
p-value: 0.00995% CI: [-1.19, -0.17]mixed-model repeated-measures
p-value: 0.09195% CI: [-0.99, 0.07]mixed-model repeated-measures
Secondary
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
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
Population: ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Duodart | 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 | -4.5 Scores on a scale | Standard Error 0.38 |
| Duodart | 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 | -3.4 Scores on a scale | Standard Error 0.33 |
| Duodart | 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 | -3.1 Scores on a scale | Standard Error 0.29 |
| Duodart | 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 | -5.2 Scores on a scale | Standard Error 0.41 |
| Duodart | 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 | -4.1 Scores on a scale | Standard Error 0.33 |
| Duodart | 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 | -4.6 Scores on a scale | Standard Error 0.36 |
p-value: <0.00195% CI: [-2.45, -0.85]mixed-model repeated-measures
p-value: 0.2495% CI: [-1.47, 0.37]mixed-model repeated-measures
p-value: 0.00695% CI: [-2.19, -0.36]mixed-model repeated-measures
p-value: <0.00195% CI: [-2.74, -0.72]mixed-model repeated-measures
p-value: 0.01395% CI: [-2.4, -0.28]mixed-model repeated-measures
p-value: <0.00195% CI: [-3.12, -0.83]mixed-model repeated-measures
Secondary
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
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
Population: ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Duodart | 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 | -2.9 Scores on a scale | Standard Error 0.45 |
| Duodart | 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 | -3.8 Scores on a scale | Standard Error 0.41 |
| Duodart | 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 | -3.6 Scores on a scale | Standard Error 0.44 |
| Duodart | 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 | -3.4 Scores on a scale | Standard Error 0.32 |
| Duodart | 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 | -4.6 Scores on a scale | Standard Error 0.49 |
| Duodart | 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 | -3.4 Scores on a scale | Standard Error 0.38 |
p-value: <0.00195% CI: [-3.89, -2.1]mixed-model repeated-measures
p-value: <0.00195% CI: [-3.15, -1.06]mixed-model repeated-measures
p-value: <0.00195% CI: [-3.25, -0.98]mixed-model repeated-measures
p-value: <0.00195% CI: [-3.76, -1.3]mixed-model repeated-measures
p-value: 0.04295% CI: [-2.56, -0.05]mixed-model repeated-measures
p-value: <0.00195% CI: [-4.87, -2.14]mixed-model repeated-measures
Secondary
Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months
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
Population: ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Duodart | 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 | -1.2 Scores on a scale | Standard Error 0.17 |
| Duodart | 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 | -1.2 Scores on a scale | Standard Error 0.17 |
| Duodart | 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 |
| Duodart | 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 | -1.2 Scores on a scale | Standard Error 0.18 |
| Duodart | 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 | -1.1 Scores on a scale | Standard Error 0.15 |
| Duodart | 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 | -0.7 Scores on a scale | Standard Error 0.14 |
p-value: 0.03695% CI: [-0.78, -0.03]mixed-model repeated-measures
p-value: 195% CI: [-0.37, 0.37]mixed-model repeated-measures
p-value: 0.2195% CI: [-0.67, 0.15]mixed-model repeated-measures
p-value: 0.00995% CI: [-1.09, -0.15]mixed-model repeated-measures
p-value: 0.05695% CI: [-0.91, 0.01]mixed-model repeated-measures
p-value: 0.02395% CI: [-1.08, -0.08]mixed-model repeated-measures
Secondary
Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months
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
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 0.3 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 0.3 |
| Duodart | Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months | Month 3, n= 189, 182 | -0.5 Scores on a scale | Standard Deviation 0.28 |
| Duodart | Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months | Month 9, n=173, 153 | -1.2 Scores on a scale | Standard Deviation 0.32 |
| Duodart | Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months | Month 6, n= 185, 168 | -1.5 Scores on a scale | Standard Deviation 0.31 |
| Duodart | Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months | Month 12, n= 169, 152 | -0.6 Scores on a scale | Standard Deviation 0.3 |
| Duodart | Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months | Month 1, n=200, 197 | -0.8 Scores on a scale | Standard Deviation 0.26 |
p-value: 0.01295% CI: [-1.67, -0.21]mixed-model repeated-measures
p-value: 0.01795% CI: [-1.69, -0.17]mixed-model repeated-measures
p-value: <0.00195% CI: [-2.57, -0.88]mixed-model repeated-measures
p-value: 0.00995% CI: [-2.01, -0.3]mixed-model repeated-measures
p-value: 0.04795% CI: [-1.65, -0.01]mixed-model repeated-measures
Secondary
Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
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
Population: ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 0.8 |
| Placebo | 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 |
| Duodart | 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 | -9.6 Scores on a scale | Standard Error 0.79 |
| Duodart | 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 | -4.6 Scores on a scale | Standard Error 0.69 |
| Duodart | 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 | -9.9 Scores on a scale | Standard Error 0.83 |
| Duodart | 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 | -6.9 Scores on a scale | Standard Error 0.73 |
p-value: <0.00195% CI: [-6.01, -2.21]mixed-model repeated-measures
p-value: <0.00195% CI: [-8.45, -4.41]Adjusted mean difference
p-value: <0.00195% CI: [-11.31, -6.77]mixed-model repeated-measures
p-value: <0.00195% CI: [-10.96, -6.67]mixed-model repeated-measures
Secondary
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent
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
Population: ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 |
| Duodart | Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent | -8.3 Scores on a scale | Standard Error 0.88 |
p-value: <0.00195% CI: [-10.22, -5.35]mixed-model repeated-measures
Secondary
Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points
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
Population: ITT Population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Duodart | 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 | -8.4 Scores on a scale | Standard Error 0.83 |
| Duodart | 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 | -8.0 Scores on a scale | Standard Error 0.86 |
p-value: <0.00195% CI: [-10.07, -5.49]mixed-model repeated-measures
p-value: <0.00195% CI: [-9.79, -4.99]mixed-model repeated-measures
Secondary
Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
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
Population: ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | >= 25 | 0 Participants |
| Placebo | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | >= 20 | 3 Participants |
| Placebo | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | <= -10 | 24 Participants |
| Placebo | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | >= 10 | 16 Participants |
| Placebo | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | <= -25 | 3 Participants |
| Placebo | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | <= -20 | 3 Participants |
| Duodart | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | >= 20 | 3 Participants |
| Duodart | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | >= 25 | 1 Participants |
| Duodart | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | <= -25 | 13 Participants |
| Duodart | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | <= -20 | 20 Participants |
| Duodart | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | >= 10 | 8 Participants |
| Duodart | Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months | <= -10 | 61 Participants |