Treatment of Erectile Dysfunction I

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

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).

Key facts

Study ID

NCT01037244

Run by

Warner Chilcott

People needed

618

Starts

2009-09-01

Expected to finish

2010-03-01

Last updated by the study team

2011-12-22

Who can join

Age: 19 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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®

Where it is running

• Warner Chilcott Investigational Site — Birmingham, Alabama, United States
• Warner Chilcott Investigational Site — Homewood, Alabama, United States
• Warner Chilcott Investigational Site — Mesa, Arizona, United States
• Warner Chilcott Investigational Site — Phoenix, Arizona, United States
• Warner Chilcott Investigational Site — Tucson, Arizona, United States
• Warner Chilcott Investigational Site — Laguna Hills, California, United States
• Warner Chilcott Investigational Site — Newport Beach, California, United States
• Warner Chilcott Investigational Site — San Diego, California, United States
• Warner Chilcott Investigational Site — Torrance, California, United States
• Warner Chilcott Investigational Site — Denver, Colorado, United States
• Warner Chilcott Investigational Site — Middlebury, Connecticut, United States
• Warner Chilcott Investigational Site — New Britain, Connecticut, United States
• Warner Chilcott Investigational Site — Waterbury, Connecticut, United States
• Warner Chilcott Investigational Site — Clearwater, Florida, United States
• Warner Chilcott Investigational Site — Miami, Florida, United States
• Warner Chilcott Investigational Site — Ocala, Florida, United States
• Warner Chilcott Investigational Site — Columbus, Georgia, United States
• Warner Chilcott Investigational Site — Melrose Park, Illinois, United States
• Warner Chilcott Investigational Site — Jeffersonville, Indiana, United States
• Warner Chilcott Investigational Site — Omaha, Nebraska, United States
• Warner Chilcott Investigational Site — Garden City, New York, United States
• Warner Chilcott Investigational Site — New York, New York, United States
• Warner Chilcott Investigational Site — Rochester, New York, United States
• Warner Chilcott Investigational Site — Chapel Hill, North Carolina, United States
• Warner Chilcott Investigational Site — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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