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

NCT00540124 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2010-11-25

Study results available
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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

  • Benign Prostatic Hyperplasia

Interventions

DRUG

Tadalafil

5 mg once a day

DRUG

Placebo

once a day

DRUG

Tamsulosin

0.2 mg once a day

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00540124 on ClinicalTrials.gov