NCT00848081

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety and Efficacy of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia on Concomitant Alpha1-Adrenergic Blocker Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Tadalafil	5 mg taken by mouth once daily for 12 weeks
DRUG	Placebo	By mouth once daily for 12 weeks

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-02-20
• Last updated: 2010-09-14
• Results posted: 2010-09-14

Locations

31 sites across 2 countries: United States, Puerto Rico