check_circleStudy Completed
Erectile Dysfunction, Spinal Cord Injury
Bayer Identifier:
11861
ClinicalTrials.gov Identifier:
EudraCT Number:
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
MaleAge
18 - 64 YearsTrial summary
Enrollment Goal
45Trial Dates
July 2005 - February 2007Phase
Phase 4Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Institut Guttmann. Hospital de neurorehabilitació | Badalona, 08916, Spain |
Completed | Hospital Nacional de Parapléjicos | Toledo, 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) 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.date_rangeTime Frame:4 treatment daysenhanced_encryptionNoSafety Issue:
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 placebodate_rangeTime Frame:4 treatment daysenhanced_encryptionNoSafety Issue:
- 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 placebodate_rangeTime Frame:4 treatment daysenhanced_encryptionNoSafety Issue:
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 4 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
2Additional Information
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