Trial Condition(s):
Evaluating the efficacy and safety of vardenafil in patients erectile dysfunction solely secondary to spinal cord injury
10473
Not Available
Not Available
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
Locations | Status | |
---|---|---|
Locations Investigative Site Many locations, United Kingdom | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, United States | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2