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Treatment of Erectile Dysfunction I

NCT ID: NCT01037244

Last Updated: 2011-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets via oral administration before an attempt at sexual intercourse.

Udenafil 50 mg

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Tablets via oral administration before an attempt at sexual intercourse.

Udenafil 100 mg

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Tablets via oral administration before an attempt at sexual intercourse.

Udenafil 150 mg

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Tablets via oral administration before an attempt at sexual intercourse.

Interventions

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Udenafil

Tablets via oral administration before an attempt at sexual intercourse.

Intervention Type DRUG

Placebo

Tablets via oral administration before an attempt at sexual intercourse.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male, at least 19 years of age
* Stable monogamous relationship for at least 6 months with a consenting female partner who 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 erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration
* Partner is not pregnant or lactating

Exclusion Criteria

* History of new-onset symptomatic coronary artery disease within the last 3 months or a history 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®
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herman Ellman, MD

Role: STUDY_DIRECTOR

Warner Chilcott

Locations

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Warner Chilcott Investigational Site

Birmingham, Alabama, United States

Site Status

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Homewood, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Laguna Hills, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Middlebury, Connecticut, United States

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New Britain, Connecticut, United States

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Waterbury, Connecticut, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Columbus, Georgia, United States

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Melrose Park, Illinois, United States

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Jeffersonville, Indiana, United States

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Omaha, Nebraska, United States

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Garden City, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Concord, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Bala-Cynwyd, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Sugar Land, Texas, United States

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Salt Lake City, Utah, United States

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Spokane, Washington, United States

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Warner Chilcott Investigational Site

Spokane, Washington, United States

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Countries

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United States

Other Identifiers

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PR-01209

Identifier Type: -

Identifier Source: org_study_id