Trial Condition(s):
Erectile Dysfunction
Evaluating the efficacy and safety of vardenafil in patients erectile dysfunction solely secondary to spinal cord injury
Bayer Identifier:
10473
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Investigate efficacy and safety of Vardenafil in patients with 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| 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 |
Trial Design
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
Primary Outcome
- International Index of Erectile Function-Erectile Function domainTimeframe: 12 weeks
Secondary Outcome
- Sexual Encounter Profile Question 2Timeframe: 12 weeks
- Sexual Encounter Profile Question 3Timeframe: 12 weeks
- Other diary based variablesTimeframe: 12 weeks
- Safety and tolerabilityTimeframe: 12 weeks
Additional Information
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