Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

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

Summary

Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

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

Details

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

Criteria

Inclusion Criteria:

• Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period.

• Stable heterosexual relationship for at least 1 month.

Exclusion Criteria:

• Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications

• 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 US Product Information or Summary of Product Characteristics