Clinical Trials Directory

Trials / Completed

CompletedNCT00540124

Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Pilot Study to Evaluate the Efficacy and Safety of Tadalafil and Tamsulosin Once-a-Day Dosing for 12 Weeks in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
151 (actual)
Sponsor
Eli Lilly and Company · Industry
Sex
Male
Age
45 Years
Healthy volunteers
Not accepted

Summary

The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.

Conditions

Interventions

TypeNameDescription
DRUGTadalafil5 mg once a day
DRUGPlaceboonce a day
DRUGTamsulosin0.2 mg once a day

Timeline

Start date
2007-10-01
Primary completion
2008-06-01
Completion
2008-06-01
First posted
2007-10-05
Last updated
2010-11-25
Results posted
2009-07-20

Locations

5 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT00540124. Inclusion in this directory is not an endorsement.

Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian (NCT00540124) · Clinical Trials Directory