Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Last updated: March 30, 2015
Sponsor: Warner Chilcott
Overall Status: Completed

Phase

3

Condition

Erectile Dysfunction

Infertility

Male Hormonal Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT01065012
PR-01409
  • Ages > 19
  • Male

Study Summary

Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has completed Study PR-01209 or PR-01309

  • Continues in a stable monogamous relationship with a consenting female partner who isat least 19 years of age.

  • Partner is not pregnant or lactating

Exclusion

Exclusion Criteria:

  • Symptomatic coronary artery disease, myocardial infarction or cardiac surgicalprocedure.

  • 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

Study Design

Total Participants: 1027
Study Start date:
January 01, 2010
Estimated Completion Date:
February 28, 2011

Study Description

Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.

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

    Huntsville, Alabama 35801
    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

    Tempe, Arizona 85282
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Chino, California 91710
    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

    Tarzana, California 91356
    United States

    Site Not Available

  • Warner Chilcott Investigative 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

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Middlebury, Connecticut 06762
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Milford, Connecticut 06460
    United States

    Site Not Available

  • Warner Chilcott Investigative 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

    Aventura, Florida 33180
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Clearwater, Florida 33761
    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

    Miami, Florida 33143
    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

    Columbus, Georgia 31904
    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

    Melrose Park, Illinois 60160
    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

    Jeffersonville, Indiana 47130
    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

    Omaha, Nebraska 68114
    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

    Garden City, New York 11530
    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

    Rochester, New York 14609
    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

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Harrisburg, North Carolina 28075
    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

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Warner Chilcott Investigative 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

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Bala Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Lancaster, Pennsylvania 17604
    United States

    Site Not Available

  • Warner Chilcott Investigational Site

    Greer, South Carolina 29650
    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

    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

    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

    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

  • Warner Chilcott Investigational Site

    Spokane, Washington 99208
    United States

    Site Not Available

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