At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 489 enrolled
Drug / intervention
Dutasteride plus tamsulosin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH
In Brief
A Phase 4 clinical trial evaluating Dutasteride plus tamsulosin and Placebo for Prostatic Hyperplasia. Completed, enrolled 489 participants across 67 sites in 7 countries.
Detailed 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 .
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Hyperplasia
CountriesAustralia, France, Germany, Greece, Hungary, Netherlands, Spain
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionApr 2016
TodayJul 2026
First PostedJan 28, 2013
Enrollment StartFeb 18, 2013
Primary CompletionApr 5, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.4 years ago
Interventions
Dutasteride plus tamsulosindrug
Take 1 capsule daily
Placebodrug
Take one capsule daily