NCT01139762

A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 696 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

Conditions

• Benign Prostatic Hyperplasia
• Enlarged Prostate

Interventions

Type	Name	Description
DRUG	Tadalafil	5 milligrams (mg) administered orally, once daily for 26 weeks
DRUG	Placebo	Administered orally, once daily for 26 weeks
DRUG	Finasteride	5mg administered orally, once daily for 26 weeks

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-02-01
• Completion: 2012-05-01
• First posted: 2010-06-09
• Last updated: 2013-02-27
• Results posted: 2013-02-27

Locations

65 sites across 13 countries: United States, Argentina, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Mexico, Poland, Russia, Turkey (Türkiye)