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Treatment of Erectile Dysfunction I

NCT01037244 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2011-12-22

Study results available
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Summary

Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).

Conditions

Interventions

DRUG

Udenafil

Tablets via oral administration before an attempt at sexual intercourse.

DRUG

Placebo

Tablets via oral administration before an attempt at sexual intercourse.

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Herman Ellman, MD · Warner Chilcott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01037244 on ClinicalTrials.gov