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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1027

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Warner Chilcott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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