Status:
COMPLETED
Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury
Lead Sponsor:
Bayer
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00654680
Start Date
October 1 2002
End Date
January 1 2004
Last Update
September 30 2013
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