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OpenTrials
Completed

NCT Number: NCT00667966

Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

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Key information

Conditions

Erectile Dysfunction Central Nervous System Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Nervous System Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Urogenital Diseases Wounds and Injuries

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Badalona, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vardenafil (Levitra, BAY 38-9456), 10 mg

Drug

10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.

Placebo

Drug

10/20 mg placebo in sequence in respective arm

Vardenafil (Levitra, BAY 38-9456), 20 mg

Drug

20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. Number of participants with adverse events

    Time frame: Approximately 4 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Acronym: LEMDE

Important dates

Study start
2005
Study completion
2007
First posted
Apr 28, 2008
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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