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

A Randomised, Double Blind, Placebo Controlled, Multi-center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction .

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

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.