CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 325 enrolled
Drug / intervention
Placebo +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.

Search/NCT00827242
NCT00827242Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Eli Lilly and Company·interventional·Posted Jan 22, 2009·Updated Nov 17, 2010

In Brief

A Phase 3 clinical trial evaluating Placebo and tadalafil for Benign Prostatic Hyperplasia. Completed, enrolled 325 participants across 27 sites in 5 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
CountriesArgentina, Germany, Italy, Mexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 22, 2009
Enrollment StartJan 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.4 years ago

Interventions

Placebodrug

Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period.

tadalafildrug

Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.