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A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

NCT01139762 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 696

Last updated 2013-02-27

Study results available
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Summary

The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

Conditions

  • Benign Prostatic Hyperplasia
  • Enlarged Prostate

Interventions

DRUG

Tadalafil

5 milligrams (mg) administered orally, once daily for 26 weeks

DRUG

Placebo

Administered orally, once daily for 26 weeks

DRUG

Finasteride

5mg administered orally, once daily for 26 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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-02-29
Completion
2012-05-31

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Mexico
  • Poland
  • Russia
  • Turkey (Türkiye)

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 NCT01139762 on ClinicalTrials.gov