Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00654680
- Lead Sponsor
- Bayer
- Brief Summary
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 418
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Vardenafil (Levitra, BAY38-9456) - Arm 2 Placebo -
- Primary Outcome Measures
Name Time Method International Index of Erectile Function-Erectile Function domain 12 weeks
- Secondary Outcome Measures
Name Time Method Sexual Encounter Profile Question 2 12 weeks Sexual Encounter Profile Question 3 12 weeks Other diary based variables 12 weeks Safety and tolerability 12 weeks