Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Verified by: Bayer, June 2009
First Received: April 24, 2008 | Last Updated: June 29, 2009 | Phase: Phase 4 | Start Date: July 2005
Overall Status: Completed | Estimated Enrollment: 51
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Assess efficacy of Vardenafil in patients with traumatic spinal cord...

Brief Summary

Official Title: “Double-Blind, Cross-Over, Placebo 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”

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: Levitra (Vardenafil, BAY38-9456)
    • 10 mg Vardenafil taken orally 1 hour prior to sexual intercourse in cross-over design with placebo
  • Drug: Placebo
    • Placebo in cross-over design

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1
  • Placebo Comparator: Arm 2

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
    • Time Frame: 4 days
      Safety Issue?: No

Secondary Measures

  • Duration of erection
    • Time Frame: 4 days
      Safety Issue?: No
  • Safety and tolerability
    • Time Frame: 4 days
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00667966

Study ID Number: 11861

ClinicalTrials.gov Identifier: NCT00667966

Health Authority: Spain: Spanish Agency of Medicines

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00667966