Evaluating the efficacy and safety of vardenafil in patients erectile dysfunction solely secondary to spinal cord injury
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury
- 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.
- 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
A rand, db, parallel-group, plac-controlled study evaluating the efficacy and safety of vardenafil administered for 12 weeks in a flexible-dose regimen compared to plac in subjects with ED solely secondary to traumatic spinal cord injury