Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction

Study to investigate the efficacy and safety of Vardenafil

Inclusion Criteria:

• Heterosexual males
• >/= 18 years old with ED for more than six months
• Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

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 Summary of Product Characteristics