drugset / Trial / NCT02431754

A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).

NCT02431754 ↗

RandomizedCrossoverDouble-blindTreatment

Summary

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period.

Timeline

Start
2015-04
Primary completion
2016-02
Completion
2016-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Tadalafil/Placebo vs Placebo/Tadalafil; p = 0.0937; Normal approximation (Z-test) NCT02431754 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tadalafil Small molecule 5 mg Oral