Study Evaluating the Efficacy and Safety of Flexible-dose 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

Study to investigate the efficacy and safety of Vardenafil

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
• Other exclusion criteria apply according to the US Product Information