BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Vardenafil Dihydrochloride

Criteria

Inclusion Criteria:

• Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.

• Stable heterosexual relationship

Exclusion Criteria:

• Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)

• Nitrate use

• Other exclusion criteria apply