Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Inclusion Criteria:

• Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
• History of unresponsiveness to sildenafil
• Stable sexual relationship for > 6 month

Exclusion Criteria:

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy