Overview

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®