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

Primary Purpose

Erectile Dysfunction, Spinal Cord Injury

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Vardenafil (Levitra, BAY 38-9456), 10 mg
Placebo
Vardenafil (Levitra, BAY 38-9456), 20 mg
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Spinal cord injury, Urodynamic, Erectile dysfunction, Vardenafil

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vardenafil + Placebo

Placebo + Vardenafil

Arm Description

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.

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.

Outcomes

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
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
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
Number of participants with adverse events

Full Information

First Posted
April 24, 2008
Last Updated
May 5, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00667966
Brief Title
Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Acronym
LEMDE
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Spinal Cord Injury
Keywords
Spinal cord injury, Urodynamic, Erectile dysfunction, Vardenafil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vardenafil + Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + Vardenafil
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vardenafil (Levitra, BAY 38-9456), 10 mg
Intervention Description
10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10/20 mg placebo in sequence in respective arm
Intervention Type
Drug
Intervention Name(s)
Vardenafil (Levitra, BAY 38-9456), 20 mg
Intervention Description
20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
4 treatment days
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Number of participants with adverse events
Time Frame
Approximately 4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Toledo
ZIP/Postal Code
45071
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

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