Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Udenafil

Criteria

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