At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 511 enrolled
Drug / intervention
Tadalafil 5 mg +3 moredrug
Likely dose
Tadalafil 5 mgfrom 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 Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
In Brief
A Phase 3 clinical trial evaluating Tadalafil 5 mg, Placebo tablet, and 2 other interventions for Benign Prostatic Hyperplasia (BPH). Completed, enrolled 511 participants across 44 sites in 10 countries.
Detailed Summary
The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia (BPH)
CountriesAustralia, Austria, Belgium, France, Germany, Greece, Italy, Mexico, Netherlands, Poland
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartOct 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedSep 2, 2009
Enrollment StartOct 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.8 years ago
Interventions
Tadalafil 5 mgdrug
Tadalafil 5 mg po QD for 12 weeks
Placebo tabletdrug
Placebo tablet po QD for 12 weeks
Tamsulosindrug
Tamsulosin 0.4 mg po QD for 12 weeks
Placebo capsuledrug
Placebo capsule po QD for 12 weeks