At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 696 enrolled
Drug / intervention
Tadalafil +2 moredrug
Likely dose
Tadalafil 5 milligramsfrom 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 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia
In Brief
A Phase 3 clinical trial evaluating Tadalafil, Placebo, and 1 other intervention for Benign Prostatic Hyperplasia and Enlarged Prostate. Completed, enrolled 696 participants across 65 sites in 13 countries.
Detailed Summary
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia, Enlarged Prostate
CountriesArgentina, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Mexico, Poland, Russia, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartSep 2010
Primary CompletionFeb 2012
Study CompletionMay 2012
TodayJul 2026
First PostedJun 9, 2010
Enrollment StartSep 1, 2010
Primary CompletionFeb 1, 2012
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.1 years ago
Interventions
Tadalafildrug
5 milligrams (mg) administered orally, once daily for 26 weeks
Placebodrug
Administered orally, once daily for 26 weeks
Finasteridedrug
5mg administered orally, once daily for 26 weeks