At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 97 enrolled
Drug / intervention
Tadalafil +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 Randomized, Double Blind, Placebo-controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
In Brief
A Phase 3 clinical trial evaluating Tadalafil and Placebo for Benign Prostatic Hyperplasia. Completed, enrolled 97 participants across 5 sites in 3 countries.
Detailed Summary
The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesAustria, Italy, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartSep 2010
Primary CompletionJul 2012
TodayJul 2026
First PostedJun 29, 2010
Enrollment StartSep 1, 2010
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.0 years ago
Interventions
Tadalafildrug
Administered orally, once daily for 8 weeks
Placebodrug
Administered orally, once daily for 8 weeks