NCT00970632

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 511 (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 (BPH)

Interventions

Type	Name	Description
DRUG	Tadalafil 5 mg	Tadalafil 5 mg po QD for 12 weeks
DRUG	Placebo tablet	Placebo tablet po QD for 12 weeks
DRUG	Tamsulosin	Tamsulosin 0.4 mg po QD for 12 weeks
DRUG	Placebo capsule	Placebo capsule po QD for 12 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-09-02
• Last updated: 2012-03-12
• Results posted: 2011-12-23

Locations

44 sites across 10 countries: Australia, Austria, Belgium, France, Germany, Greece, Italy, Mexico, Netherlands, Poland