Treatment of Erectile Dysfunction I

Last updated: December 21, 2011
Sponsor: Warner Chilcott
Overall Status: Completed

Phase

3

Condition

Impotence

Male Hormonal Deficiencies/abnormalities

Erectile Dysfunction

Treatment

N/A

Clinical Study ID

NCT01037244
PR-01209
  • 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: 618
Study Start date:
September 01, 2009
Estimated Completion Date:
March 31, 2010

Connect with a study center

  • Warner Chilcott Investigational Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Homewood, Alabama 35209
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Mesa, Arizona 85213
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Phoenix, Arizona 85023
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    San Diego, California 92103
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Torrance, California 90505
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Denver, Colorado 80211
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Middlebury, Connecticut 06762
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    New Britain, Connecticut 06052
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Miami, Florida 33143
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Ocala, Florida 34474
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Melrose Park, Illinois 60160
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Jeffersonville, Indiana 47130
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Garden City, New York 11530
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    New York, New York 10016
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Rochester, New York 14609
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Charlotte, North Carolina 28226
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Bala Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Spokane, Washington 99208
    United States

    Site Not Available

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