Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Cord Injuries; Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
Clinical Details
Official title: Double-Blind, Cross-Over, Plac Controlled Pilot Study to Characterize the Profile of Those Patients With Traumatic Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Characteristics of responders and non responder with respect to the electrophysiological (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamical and clinical (ASIA group) tests
Secondary outcome: Duration of erectionSafety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Toledo 45071, Spain
Badalona, Barcelona 08916, Spain
Additional Information
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Starting date: July 2005
Ending date: February 2007
Last updated: April 27, 2008
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