Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

Study to investigate the efficacy and safety of Vardenafil

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

Details

• Lead Sponsor: Bayer
• Collaborator: GlaxoSmithKline
• Treatments: Vardenafil Dihydrochloride

Criteria

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