NCT01152190

A Study in Benign Prostatic Hyperplasia

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Tadalafil	Administered orally, once daily for 8 weeks
DRUG	Placebo	Administered orally, once daily for 8 weeks

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-06-29
• Last updated: 2013-05-20
• Results posted: 2013-05-20

Locations

5 sites across 3 countries: United States, Austria, Italy