MedTrace Logo

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

NCT00970632 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2012-03-12

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

DRUG

Tadalafil 5 mg

Tadalafil 5 mg po QD for 12 weeks

DRUG

Placebo tablet

Placebo tablet po QD for 12 weeks

DRUG

Tamsulosin

Tamsulosin 0.4 mg po QD for 12 weeks

DRUG

Placebo capsule

Placebo capsule po QD for 12 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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Australia
  • Austria
  • Belgium
  • France
  • Germany
  • Greece
  • Italy
  • Mexico
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

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 NCT00970632 on ClinicalTrials.gov