NCT01937871

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 909 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostate Hyperplasia
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	5 mg Tadalafil	Administered orally
DRUG	Placebo	Administered orally
DRUG	0.2 mg Tamsulosin	Administered orally

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-09-10
• Last updated: 2017-06-20
• Results posted: 2017-02-07

Locations

14 sites across 1 country: China