Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

March 30, 2015 updated by: Warner Chilcott

Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1027

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Warner Chilcott Investigational Site
      • Homewood, Alabama, United States, 35209
        • Warner Chilcott Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Warner Chilcott Investigational Site
    • Arizona
      • 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
        • Warner Chilcott Investigational Site
    • California
      • 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 Investigational Site
      • Torrance, California, United States, 90505
        • Warner Chilcott Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80211
        • Warner Chilcott Investigational Site
      • Englewood, Colorado, United States, 80113
        • Warner Chilcott Investigational Site
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Warner Chilcott Investigational Site
      • Milford, Connecticut, United States, 06460
        • Warner Chilcott Investigational Site
      • New Britain, Connecticut, United States, 06052
        • Warner Chilcott Investigative Site
      • Waterbury, Connecticut, United States, 06708
        • Warner Chilcott Investigational Site
    • Florida
      • 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, 34471
        • Warner Chilcott Investigational Site
      • Ocala, Florida, United States, 34474
        • Warner Chilcott Investigational Site
      • Tampa, Florida, United States, 33607
        • Warner Chilcott Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Warner Chilcott Investigational Site
      • Dawsonville, Georgia, United States, 30534
        • Warner Chilcott Investigational Site
      • Sandy Springs, Georgia, United States, 30328
        • Warner Chilcott Investigational Site
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • Warner Chilcott Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Warner Chilcott Investigational Site
      • Greenwood, Indiana, United States, 46143
        • Warner Chilcott Investigational Site
      • Jeffersonville, Indiana, United States, 47130
        • Warner Chilcott Investigational Site
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Warner Chilcott Investigational Site
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Warner Chilcott Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Warner Chilcott Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Warner Chilcott Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Warner Chilcott Investigational Site
    • New York
      • 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
        • Warner Chilcott Investigational Site
    • North Carolina
      • 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, 27612
        • Warner Chilcott Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Warner Chilcott Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Warner Chilcott Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Warner Chilcott Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Warner Chilcott Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Warner Chilcott Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Warner Chilcott Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Warner Chilcott Investigational Site
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Warner Chilcott Investigational Site
      • Jenkintown, Pennsylvania, United States, 19046
        • Warner Chilcott Investigational Site
      • Lancaster, Pennsylvania, United States, 17604
        • Warner Chilcott Investigational Site
    • South Carolina
      • 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
        • Warner Chilcott Investigational Site
    • Texas
      • 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
        • Warner Chilcott Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Warner Chilcott Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Warner Chilcott Investigational Site
      • Richmond, Virginia, United States, 23294
        • Warner Chilcott Investigational Site
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Warner Chilcott Investigational Site
      • Spokane, Washington, United States, 99204
        • Warner Chilcott Investigational Site
      • Spokane, Washington, United States, 99208
        • Warner Chilcott Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Udenafil 50 mg
50 mg Udenafil
Drug: Udenafil 50 mg
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.
Other Names:
  • WC3043
Drug: Placebo Matching 100 mg 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.
Other Names:
  • Placebo 100 mg
Drug: Placebo Matching 150 mg 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.
Other Names:
  • Placebo 150 mg
Experimental: Udenafil 100 mg
100 mg Udenafil
Drug: Placebo Matching 150 mg 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.
Other Names:
  • Placebo 150 mg
Drug: Udenafil 100 mg
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.
Other Names:
  • WC3043
Drug: Placebo Matching 50 mg 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.
Other Names:
  • Placebo 50 mg
Experimental: Udenafil 150 mg
150 mg Udenafil
Drug: Placebo Matching 100 mg 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.
Other Names:
  • Placebo 100 mg
Drug: Placebo Matching 50 mg 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.
Other Names:
  • Placebo 50 mg
Drug: Udenafil 150 mg
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.
Other Names:
  • WC3043
Placebo Comparator: Placebo
Placebo Tablets matching Udenafil tablets
Drug: Placebo Matching 100 mg 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.
Other Names:
  • Placebo 100 mg
Drug: Placebo Matching 150 mg 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.
Other Names:
  • Placebo 150 mg
Drug: Placebo Matching 50 mg 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.
Other Names:
  • Placebo 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Assessment will be made after each use of the study drug over a 36 week use period.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Assessment will be made after each use of the study drug over a 36 week use period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: Herman Ellman, MD, Warner Chilcott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

April 20, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-01409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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