NCT00384930

Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,058 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	tadalafil	2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
DRUG	tadalafil	5 mg tadalafil tablet by mouth once a day for twelve weeks.
DRUG	tadalafil	10 mg tadalafil tablet by mouth once a day for twelve weeks.
DRUG	tadalafil	20 mg tadalafil tablet by mouth once a day for twelve weeks.
DRUG	placebo	Placebo tablet taken by mouth one a day for twelve weeks

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-10-01
• Completion: 2008-10-01
• First posted: 2006-10-06
• Last updated: 2009-09-02
• Results posted: 2009-08-19

Locations

1 site across 1 country: United States