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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction Spinal Cord Injuries

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

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

Badalona, Barcelona, Spain, 08916

Toledo, Spain, 45071

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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
ClinicalTrials.gov Identifier:	NCT00667966 History of Changes
Other Study ID Numbers:	11861, EudraCT No: 2004-005282-37
Study First Received:	April 24, 2008
Last Updated:	June 29, 2009
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Bayer:

Spinal cord injury
Urodynamic
Erectile dysfunction
Vardenafil

Additional relevant MeSH terms:

Spinal Cord Injuries
Erectile Dysfunction
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders

Mental Disorders
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012