Trial Condition(s):
Erectile Dysfunction, Spinal Cord Injury
Assess efficacy in subjects with traumatic spinal cord injury (LEMDE)
Bayer Identifier:
11861
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Institut Guttmann. Hospital de neurorehabilitació Badalona, Spain, 08916 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional de Parapléjicos Toledo, Spain, 45071 | Status Completed | Contact Us: E-mail: clin[email protected] Phone: Not Available |
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
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) testsResponders 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.Timeframe: 4 treatment days
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 placeboTimeframe: 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 placeboTimeframe: 4 treatment days
- Number of participants with adverse eventsTimeframe: Approximately 4 weeks
Additional Information
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