Assessment of Duration of Erection With Vardenafil 10 mg - Full Text View

Sponsor:	Bayer
Collaborator:	GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00663728

Purpose

This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Crossover Study to Evaluate the Duration of Erection Following Vardenafil (10mg) Administration for Four Weeks in a Fixed Dose Regimen Compared to Placebo in Males With ED

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Effect of vardenafil on the duration of erection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Perception of erection to be hard enough for penetration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	September 2004
Study Completion Date:	April 2005

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

Eligibility

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

Criteria

Inclusion Criteria:

Males with erectile dysfunction
Stable heterosexual relationship

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663728

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators

Study Director:

Bayer Study Direct

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	11575
Study First Received:	April 17, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00663728 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010