MedTrace Logo

Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

NCT00384930 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1058

Last updated 2009-09-02

Study results available
· View outcomes & findings →

Summary

This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

tadalafil

2.5 mg tadalafil tablet by mouth once a day for twelve weeks.

DRUG

tadalafil

5 mg tadalafil tablet by mouth once a day for twelve weeks.

DRUG

tadalafil

10 mg tadalafil tablet by mouth once a day for twelve weeks.

DRUG

tadalafil

20 mg tadalafil tablet by mouth once a day for twelve weeks.

DRUG

placebo

Placebo tablet taken by mouth one a day for twelve weeks

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
2006-08-31
Primary Completion
2007-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00384930 on ClinicalTrials.gov