Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

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).

Key facts

Study ID

NCT01065012

Run by

Warner Chilcott

People needed

1027

Starts

2010-01-01

Expected to finish

2011-02-01

Last updated by the study team

2015-04-20

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Warner Chilcott Investigational Site — Homewood, Alabama, United States
• Warner Chilcott Investigational Site — Huntsville, Alabama, United States
• Warner Chilcott Investigational Site — Mesa, Arizona, United States
• Warner Chilcott Investigational Site — Phoenix, Arizona, United States
• Warner Chilcott Investigational Site — Tempe, Arizona, United States
• Warner Chilcott Investigational Site — Tucson, Arizona, United States
• Warner Chilcott Investigational Site — Chino, California, 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 — Tarzana, California, United States
• Warner Chilcott Investigative Site — Torrance, California, United States
• Warner Chilcott Investigational Site — Denver, Colorado, United States
• Warner Chilcott Investigational Site — Englewood, Colorado, United States
• Warner Chilcott Investigational Site — Middlebury, Connecticut, United States
• Warner Chilcott Investigational Site — Milford, Connecticut, United States
• Warner Chilcott Investigative Site — New Britain, Connecticut, United States
• Warner Chilcott Investigational Site — Waterbury, Connecticut, United States
• Warner Chilcott Investigational Site — Aventura, Florida, United States
• Warner Chilcott Investigational Site — Clearwater, Florida, United States
• Warner Chilcott Investigational Site — Daytona Beach, Florida, United States
• Warner Chilcott Investigational Site — DeLand, Florida, United States
• Warner Chilcott Investigational Site — Miami, Florida, United States
• Warner Chilcott Investigational Site — Ocala, Florida, United States
• Warner Chilcott Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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