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

May 5, 2015 updated by: Bayer

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)

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45071
    • Barcelona
      • Badalona, Barcelona, Spain, 08916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 treatment days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
4 treatment days
Number of participants with adverse events
Time Frame: Approximately 4 weeks
Approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 27, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11861
  • 2004-005282-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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