Treatment of Erectile Dysfunction II

Last updated: May 20, 2015
Sponsor: Warner Chilcott
Overall Status: Completed

Phase

3

Condition

Erectile Dysfunction

Male Hormonal Deficiencies/abnormalities

Infertility

Treatment

N/A

Clinical Study ID

NCT01037218
PR-01309
  • Ages > 19
  • Male

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male, at least 19 years of age

  • Stable monogamous relationship for at least 6 months with a consenting female partnerwho is at least 19 years of age, vaginal intercourse is a required study activity

  • History of ED (clinically defined as the inability to attain and maintain an erectionof the penis sufficient to permit satisfactory sexual intercourse) of at least 3months duration

  • Partner is not pregnant or lactating

Exclusion

Exclusion Criteria:

  • History of new-onset symptomatic coronary artery disease within the last 3 months or ahistory of myocardial infarction or cardiac surgical procedure within six months

  • Cardiac arrhythmias requiring antiarrhythmic treatment

  • Symptomatic congestive heart failure

  • Taking nitrate medication in any form

  • Uncontrolled diabetes (HbA1c ≥ 13%)

  • Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors such as Viagra®,Cialis® or Levitra®

  • Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®

Study Design

Total Participants: 601
Study Start date:
September 01, 2009
Estimated Completion Date:
April 30, 2010

Study Description

Multi-center, randomized, double-blind, placebo-controlled, parallel-group design, Phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ED. This study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen.

Connect with a study center

  • Warner Chilcott Investigational Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Tempe, Arizona 85282
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Chino, California 91710
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Tarzana, California 91356
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Milford, Connecticut 06460
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Aventura, Florida 33180
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Daytona Beach, Florida 32114
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    DeLand, Florida 32720
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Ocala, Florida 34471
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Dawsonville, Georgia 30534
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Fort Wayne, Indiana 46825
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Greenwood, Indiana 46143
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Elkridge, Maryland 21075
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Brooklyn, New York 11219
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Kingston, New York 12401
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    New York, New York 10016
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Williamsville, New York 14221
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Cary, North Carolina 27518
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Lancaster, Pennsylvania 17604-3200
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Greer, South Carolina 29650
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Arlington, Texas 76017
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Mountlake Terrace, Washington 98043
    United States

    Site Not Available

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