BAY38-9456 - Pivotal Trial for Diabetes Patient

A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Inclusion Criteria:

• Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
• Diabetes for more than 3 years

Exclusion Criteria:

• Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
• Spinal cord injury
• History of surgical prostatectomy (excluding TURP)
• Patients with an HbA1c > 12% at Visit 1
• Use of nitrates
• Use of potent CYP3a4 inhibitors
• Severe liver disease
• Presence of Peyronie's Disease