Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury - Full Text View

Purpose

Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase III

MedlinePlus related topics:

Erectile Dysfunction Spinal Cord Injuries

ChemIDplus related topics:

Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Rand, db, Parallel-Group, Plac-Controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-Dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury

Further study details as provided by Bayer:

Primary Outcome Measures:

International Index of Erectile Function-Erectile Function domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Other diary based variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	418
Study Start Date:	October 2002
Study Completion Date:	January 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse
Arm 2: Placebo Comparator	Drug: Placebo Matching placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males ≥18 years with ED solely as a result of traumatic SCI for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period.
Stable heterosexual relationship for at least 1 month.

Exclusion Criteria:

Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications
Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
Nitrate therapy
Other exclusion criteria apply according to US Product Information or Summary of Product Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654680

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	10473
First Received:	April 4, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00654680
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction

Traumatic spinal cord injury

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

Mental Disorders

Neoplasm Metastasis

Erectile Dysfunction

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Enzyme Inhibitors

Sexual and Gender Disorders

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Bayer GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00654680