check_circleStudy Completed

Erectile Dysfunction, Spinal Cord Injury

Bayer Identifier:

11861

ClinicalTrials.gov Identifier:

NCT00667966

EudraCT Number:

2004-005282-37

EU CT Number:

Not Available
Assess efficacy in subjects with traumatic spinal cord injury

Trial purpose

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Key Participants Requirements

Sex

Male

Age

18 - 64 Years

  • - 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

  • - Primary hypoactive sexual desire
    - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
    - Nitrate therapy

Trial summary

Enrollment Goal
45
Trial Dates
July 2005 - February 2007
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Institut Guttmann. Hospital de neurorehabilitacióBadalona, 08916, Spain
Completed
Hospital Nacional de ParapléjicosToledo, 45071, Spain

Primary Outcome

  • 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.
    date_rangeTime Frame:
    4 treatment days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    4 treatment days
    enhanced_encryption
    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
    date_rangeTime Frame:
    4 treatment days
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 4 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find information about studies related to Bayer Healthcare products conducted in EuropeClick here to find results for studies related to Bayer Healthcare products.