Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— LEMDE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667966
• Other study ID #: 11861
• Secondary ID: 2004-005282-37
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2008
• Last updated: May 5, 2015
• Start date: July 2005
• Est. completion date: February 2007

Study information

• Verified date: May 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Vardenafil (Levitra, BAY 38-9456), 10 mg
10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
• Placebo
10/20 mg placebo in sequence in respective arm
• Vardenafil (Levitra, BAY 38-9456), 20 mg
20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of participants with adverse events		Approximately 4 weeks	Yes

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