At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 318 enrolled
Drug / intervention
Tadalafil +1 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 Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy
In Brief
A Phase 3 clinical trial evaluating Tadalafil and Placebo for Benign Prostatic Hyperplasia. Completed, enrolled 318 participants across 31 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartMar 2009
Primary CompletionDec 2009
TodayJul 2026
First PostedFeb 20, 2009
Enrollment StartMar 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.4 years ago
Interventions
Tadalafildrug
5 mg taken by mouth once daily for 12 weeks
Placebodrug
By mouth once daily for 12 weeks