Assess Efficacy in Subjects With Traumatic Spinal Cord Injury (LEMDE)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00667966
First received: April 24, 2008
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury


Condition Intervention Phase
Erectile Dysfunction
Spinal Cord Injuries
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of erection [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: July 2005
Study Completion Date: February 2007
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil taken orally 1 hour prior to sexual intercourse in cross-over design with placebo
Placebo Comparator: Arm 2 Drug: Placebo
Placebo in cross-over design

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667966

Locations
Spain
Badalona, Barcelona, Spain, 08916
Toledo, Spain, 45071
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00667966     History of Changes
Other Study ID Numbers: 11861, EudraCT No: 2004-005282-37
Study First Received: April 24, 2008
Last Updated: June 29, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
Spinal cord injury
Urodynamic
Erectile dysfunction
Vardenafil

Additional relevant MeSH terms:
Spinal Cord Injuries
Erectile Dysfunction
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 20, 2014