Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01065012
First received: February 5, 2010
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Erectile Dysfunction
Drug: Udenafil
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • International Index of Erectile Function (IIEF) score [ Time Frame: Assessment will be made after each use of the study drug over a 36 week use period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction [ Time Frame: Assessment will be made after each use of the study drug over a 36 week use period. ] [ Designated as safety issue: No ]

Enrollment: 1027
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-Label
Subjects initially assigned to 100 mg dose but may titrate down to 50 mg or up to 150 mg as determined by subject and Investigator.
Drug: Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has completed Study PR-01209 or PR-01309
  • Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
  • Partner is not pregnant or lactating

Exclusion Criteria:

  • Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065012

  Hide Study Locations
Locations
United States, Alabama
Warner Chilcott Investigational Site
Birmingham, Alabama, United States, 35209
Warner Chilcott Investigational Site
Homewood, Alabama, United States, 35209
Warner Chilcott Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Warner Chilcott Investigational Site
Mesa, Arizona, United States, 85213
Warner Chilcott Investigational Site
Phoenix, Arizona, United States, 85023
Warner Chilcott Investigational Site
Tempe, Arizona, United States, 85282
Warner Chilcott Investigational Site
Tucson, Arizona, United States, 85741
United States, California
Warner Chilcott Investigational Site
Chino, California, United States, 91710
Warner Chilcott Investigational Site
Laguna Hills, California, United States, 92653
Warner Chilcott Investigational Site
Newport Beach, California, United States, 92660
Warner Chilcott Investigational Site
San Diego, California, United States, 92103
Warner Chilcott Investigational Site
Tarzana, California, United States, 91356
Warner Chilcott Investigative Site
Torrance, California, United States, 90505
United States, Colorado
Warner Chilcott Investigational Site
Denver, Colorado, United States, 80211
Warner Chilcott Investigational Site
Englewood, Colorado, United States, 80113
United States, Connecticut
Warner Chilcott Investigational Site
Middlebury, Connecticut, United States, 06762
Warner Chilcott Investigational Site
Milford, Connecticut, United States, 06460
Warner Chilcott Investigative Site
New Britain, Connecticut, United States, 06052
Warner Chilcott Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Warner Chilcott Investigational Site
Aventura, Florida, United States, 33180
Warner Chilcott Investigational Site
Clearwater, Florida, United States, 33761
Warner Chilcott Investigational Site
Daytona Beach, Florida, United States, 32114
Warner Chilcott Investigational Site
DeLand, Florida, United States, 32720
Warner Chilcott Investigational Site
Miami, Florida, United States, 33143
Warner Chilcott Investigational Site
Ocala, Florida, United States, 34474
Warner Chilcott Investigational Site
Ocala, Florida, United States, 34471
Warner Chilcott Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Warner Chilcott Investigational Site
Columbus, Georgia, United States, 31904
Warner Chilcott Investigational Site
Dawsonville, Georgia, United States, 30534
Warner Chilcott Investigational Site
Sandy Springs, Georgia, United States, 30328
United States, Illinois
Warner Chilcott Investigational Site
Melrose Park, Illinois, United States, 60160
United States, Indiana
Warner Chilcott Investigational Site
Fort Wayne, Indiana, United States, 46825
Warner Chilcott Investigational Site
Greenwood, Indiana, United States, 46143
Warner Chilcott Investigational Site
Jeffersonville, Indiana, United States, 47130
United States, Iowa
Warner Chilcott Investigational Site
West Des Moines, Iowa, United States, 50266
United States, Maryland
Warner Chilcott Investigational Site
Elkridge, Maryland, United States, 21075
United States, Nebraska
Warner Chilcott Investigational Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Warner Chilcott Investigational Site
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Warner Chilcott Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, New York
Warner Chilcott Investigational Site
Bay Shore, New York, United States, 11706
Warner Chilcott Investigational Site
Garden City, New York, United States, 11530
Warner Chilcott Investigational Site
Kingston, New York, United States, 12401
Warner Chilcott Investigational Site
New York, New York, United States, 10016
Warner Chilcott Investigational Site
Poughkeepsie, New York, United States, 12601
Warner Chilcott Investigational Site
Rochester, New York, United States, 14609
Warner Chilcott Investigational Site
Williamsville, New York, United States, 14221
United States, North Carolina
Warner Chilcott Investigational Site
Cary, North Carolina, United States, 27518
Warner Chilcott Investigational Site
Concord, North Carolina, United States, 28025
Warner Chilcott Investigational Site
Harrisburg, North Carolina, United States, 28075
Warner Chilcott Investigational Site
Raleigh, North Carolina, United States, 27609
Warner Chilcott Investigational Site
Raleigh, North Carolina, United States, 27612
Warner Chilcott Investigational Site
Salisbury, North Carolina, United States, 28144
Warner Chilcott Investigational Site
Wilmington, North Carolina, United States, 28401
Warner Chilcott Investigative Site
Wilmington, North Carolina, United States, 28401
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Warner Chilcott Investigational Site
Cincinnati, Ohio, United States, 45212
Warner Chilcott Investigational Site
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Warner Chilcott Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
Warner Chilcott Investigational Site
Jenkintown, Pennsylvania, United States, 19046
Warner Chilcott Investigational Site
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Warner Chilcott Investigational Site
Greer, South Carolina, United States, 29650
Warner Chilcott Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
Warner Chilcott Investigational Site
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Warner Chilcott Investigational Site
Arlington, Texas, United States, 76017
Warner Chilcott Investigational Site
San Antonio, Texas, United States, 78229
Warner Chilcott Investigational Site
Sugar Land, Texas, United States, 77479
United States, Utah
Warner Chilcott Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Warner Chilcott Investigational Site
Norfolk, Virginia, United States, 23502
Warner Chilcott Investigational Site
Richmond, Virginia, United States, 23294
United States, Washington
Warner Chilcott Investigational Site
Mountlake Terrace, Washington, United States, 98043
Warner Chilcott Investigational Site
Spokane, Washington, United States, 99208
Warner Chilcott Investigational Site
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Warner Chilcott
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01065012     History of Changes
Other Study ID Numbers: PR-01409
Study First Received: February 5, 2010
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014