Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

• Phase: Phase 2/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