Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Phase 4CompletedNCT00667966

Bayer45 enrolled

Overview

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Erectile Dysfunction Spinal Cord Injury

Interventions

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

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

PlaceboDRUG

10/20 mg placebo in sequence in respective arm

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

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Badalona, Barcelona, Spain

Unnamed facility

Toledo, Toledo, Spain

Outcomes

Primary Outcomes

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.

Time frame: 4 treatment days

Secondary Outcomes

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

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

Number of participants with adverse events

Time frame: Approximately 4 weeks

Data from ClinicalTrials.gov

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