Trial Condition(s):

Erectile Dysfunction, Spinal Cord Injury

Assess efficacy in subjects with traumatic spinal cord injury (LEMDE)

Bayer Identifier:

11861

ClinicalTrials.gov Identifier:

NCT00667966

EudraCT Number:

2004-005282-37

Study Completed

Trial Purpose

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Inclusion Criteria
- Men between 18 and 64 years old with stable cord injury (more than 6 months) who had erectile dysfunction according to the National Institutes if Health (NIH) after their traumatic spinal cord injury
Exclusion Criteria
- Primary hypoactive sexual desire 
 - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month 
 - Nitrate therapy

Trial Summary

Enrollment Goal
45
Trial Dates
black-arrow
Phase
4
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

Institut Guttmann. Hospital de neurorehabilitació

Badalona, Spain, 08916

Status
Completed
 
Locations

Hospital Nacional de Parapléjicos

Toledo, Spain, 45071

Status
Completed
 

Trial Design