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A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

NCT00855582 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2011-07-28

Study results available
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Summary

Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

Conditions

Interventions

DRUG

Tadalafil

tablet once daily by mouth for 12 weeks.

DRUG

Placebo

Matching 2.5 or 5 mg placebo tablet once daily by mouth 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
2009-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Mexico
  • Portugal
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00855582 on ClinicalTrials.gov