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:

NCT00654680

EudraCT Number:

Not Available

Study Completed

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
418
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, United Kingdom

Status
Terminated
 
Locations

Investigative Site

Many locations, United States

Status
Completed
 

Trial Design