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

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