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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00667966
First received: April 24, 2008
Last updated: May 5, 2015
Last verified: May 2015
  Purpose

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury


Condition Intervention Phase
Erectile Dysfunction
Spinal Cord Injury
Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg
Drug: Placebo
Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg
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 Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil Treatment. (LEMDE)

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 treatment days ] [ Designated as safety issue: No ]
    Responders are defined as subjects with rigidity ≥ 60% in the base measured with RigiScan during at least 5 minutes after withdrawing the vibrator and/or finishing manual stimulation.


Secondary Outcome Measures:
  • Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 10 mg dose of vardenafil or placebo [ Time Frame: 4 treatment days ] [ Designated as safety issue: No ]
  • Duration of an erection ≥ 60% in the base induced by an erectogenic stimulus (vibrator and/or manual) in each subject after administering a 20 mg dose of vardenafil or placebo [ Time Frame: 4 treatment days ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: July 2005
Study Completion Date: February 2007
Arms Assigned Interventions
Experimental: Vardenafil + Placebo
Subjects received single dose of 10 mg vardenafil followed by 20 mg vardenafil and then crossed over to 10 mg placebo followed by 20 mg placebo.
Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg
10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Drug: Placebo
10/20 mg placebo in sequence in respective arm
Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg
20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Experimental: Placebo + Vardenafil
Subjects received single dose of 10 mg placebo followed by 20 mg placebo and then crossed over to 10 mg vardenafil followed by 20 mg vardenafil.
Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg
10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Drug: Placebo
10/20 mg placebo in sequence in respective arm
Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg
20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.

  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: Bayer
ClinicalTrials.gov Identifier: NCT00667966     History of Changes
Other Study ID Numbers: 11861, 2004-005282-37
Study First Received: April 24, 2008
Last Updated: May 5, 2015
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on August 04, 2015