To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

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

Details

• Lead Sponsor: Bayer
• Treatments: Vardenafil Dihydrochloride

Criteria

Inclusion Criteria:

• Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months

• having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

Exclusion Criteria:

• Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.

• Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.

• Subjects could not be on androgens/anti-androgens or alpha blockers.