NCT00855582

A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

Conditions

• Erectile Dysfunction
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Tadalafil	tablet once daily by mouth for 12 weeks.
DRUG	Placebo	Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-03-04
• Last updated: 2011-07-28
• Results posted: 2011-06-30

Locations

52 sites across 9 countries: United States, Canada, France, Germany, Greece, Italy, Mexico, Portugal, Russia