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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00667966
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE April 24, 2008
First Posted Date  ICMJE April 28, 2008
Last Update Posted Date May 6, 2015
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
  • 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 ]
  • 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 ]
  • Number of participants with adverse events [ Time Frame: Approximately 4 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2008)
  • Duration of erection [ Time Frame: 4 days ]
  • Safety and tolerability [ Time Frame: 4 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Official Title  ICMJE 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)
Brief Summary Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Erectile Dysfunction
  • Spinal Cord Injury
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg
    • Drug: Placebo
    • Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg
  • 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.
    Interventions:
    • Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg
    • Drug: Placebo
    • Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2014)
45
Original Actual Enrollment  ICMJE
 (submitted: April 27, 2008)
51
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00667966
Other Study ID Numbers  ICMJE 11861
2004-005282-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP