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A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

NCT00848081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2010-09-14

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

Tadalafil

5 mg taken by mouth once daily for 12 weeks

DRUG

Placebo

By mouth once daily 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 hourse, 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
2009-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States
  • Puerto Rico

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 NCT00848081 on ClinicalTrials.gov