CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 909 enrolled
Drug / intervention
5 mg Tadalafil +2 moredrug
Likely dose
5 mg Tadalafilfrom 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/NCT01937871
NCT01937871Phase 3Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Sep 10, 2013·Updated Jun 20, 2017

In Brief

A Phase 3 clinical trial evaluating 5 mg Tadalafil, Placebo, and 1 other intervention for Benign Prostate Hyperplasia and Erectile Dysfunction. Completed, enrolled 909 participants across 14 sites.

Detailed Summary

The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostate Hyperplasia, Erectile Dysfunction
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 10, 2013
Enrollment StartSep 1, 2013
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.8 years ago

Interventions

5 mg Tadalafildrug

Administered orally

Placebodrug

Administered orally

0.2 mg Tamsulosindrug

Administered orally