Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Phase 4

Completed

• Conditions: Spinal Cord Injury; Erectile Dysfunction
• Interventions: Drug: Vardenafil (Levitra, BAY 38-9456), 10 mg; Drug: Placebo; Drug: Vardenafil (Levitra, BAY 38-9456), 20 mg

• Registration Number: NCT00667966
• Lead Sponsor: Bayer

Brief Summary

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study Completion: 2007-02
• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-27
• Study First Posted: 2008-04-28
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo + Vardenafil	Vardenafil (Levitra, BAY 38-9456), 20 mg	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.
Vardenafil + Placebo	Vardenafil (Levitra, BAY 38-9456), 20 mg	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.
Vardenafil + Placebo	Placebo	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.
Placebo + Vardenafil	Placebo	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.
Vardenafil + Placebo	Vardenafil (Levitra, BAY 38-9456), 10 mg	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.
Placebo + Vardenafil	Vardenafil (Levitra, BAY 38-9456), 10 mg	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.

Primary Outcome Measures

Name	Time	Method
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	4 treatment days	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.

Secondary Outcome Measures

Name	Time	Method
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
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
Number of participants with adverse events	Approximately 4 weeks