At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 200 enrolled
Drug / intervention
Tadalafil +1 moredrug
Likely dose
Tadalafil 20 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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
In Brief
A Phase 2 clinical trial evaluating Tadalafil and Placebo for Benign Prostatic Hyperplasia. Completed, enrolled 200 participants across 13 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesGreece, Portugal, United States
CollaboratorsICOS Corporation
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedOct 2006
Primary CompletionMay 2008
TodayJul 2026
First PostedOct 11, 2006
Enrollment StartOct 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.7 years ago
Interventions
Tadalafildrug
20 mg tadalafil tablet taken by mouth once a day for 12 weeks.
Placebodrug
Placebo tablet taken by mouth once a day for 12 weeks.