Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Study Overview
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Brief Summary
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Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Official Title
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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)

Conditions
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Erectile Dysfunction, Spinal Cord Injury

Intervention / Treatment
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* Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg
* Drug: Placebo
* Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vardenafil + Placebo<br>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<br>* 10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.<br>Drug: Placebo<br>* 10/20 mg placebo in sequence in respective arm<br>Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg<br>* 20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.<br>|
| Experimental: Placebo + Vardenafil<br>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<br>* 10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.<br>Drug: Placebo<br>* 10/20 mg placebo in sequence in respective arm<br>Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg<br>* 20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.<br>|

What is the study measuring?
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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 | 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 | Measure Description | 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 |  | 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 |  | 4 treatment days | 
| Number of participants with adverse events |  | Approximately 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, Urodynamic, Erectile dysfunction, Vardenafil