Assess Efficacy in Subjects With Traumatic Spinal Cord Injury - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00667966

Purpose

Assess efficacy of Vardenafil in patients with traumatic spinal cord injury

Condition	Intervention	Phase
Erectile Dysfunction Spinal Cord Injuries	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase IV

MedlinePlus related topics: Erectile Dysfunction Spinal Cord Injuries

Drug Information available for: Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Cross-Over, Placebo Controlled Pilot Study to Characterize the Profile of Those Patients With Traumatic Spinal Cord Injury Diagnosed by Electrophysiological, Urodynamic and Clinical (ASIA Group) Assessment Who May Respond to Vardenafil

Further study details as provided by Bayer:

Primary Outcome Measures:

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 [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of erection [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Enrollment:	51
Study Start Date:	July 2005
Study Completion Date:	February 2007

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 10 mg Vardenafil taken orally 1 hour prior to sexual intercourse in cross-over design with placebo
Arm 2: Placebo Comparator	Drug: Placebo Placebo in cross-over design

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667966

Locations

Spain

Toledo, Spain, 45071
Spain, Barcelona

Badalona, Barcelona, Spain, 08916

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head ( Bayer Healthcare AG )
Study ID Numbers:	11861, EudraCT No: 2004-005282-37
Study First Received:	April 24, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00667966 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Bayer:

Spinal cord injury
Urodynamic
Erectile dysfunction
Vardenafil

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Spinal Cord Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Genital Diseases, Male

Spinal Cord Injuries
Sexual Dysfunction, Physiological
Vardenafil
Phosphodiesterase Inhibitors
Mental Disorders
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Molecular Mechanisms of Pharmacological Action
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Enzyme Inhibitors
Trauma, Nervous System

Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
Spinal Cord Injuries
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Mental Disorders
Erectile Dysfunction

ClinicalTrials.gov processed this record on May 07, 2009