Treatment of Erectile Dysfunction I

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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).

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

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Udenafil

Criteria

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®