NCT00827242

Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Placebo	Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period.
DRUG	tadalafil	Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-01-22
• Last updated: 2010-11-17
• Results posted: 2010-11-17

Locations

27 sites across 5 countries: United States, Argentina, Germany, Italy, Mexico