Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil - Full Text View

Sponsor:	Bayer
Collaborator:	GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00661297

Purpose

Study to investigate the efficacy and safety of Vardenafil

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction

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:

Sexual Encounter Profile question 2 (SEP 2) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sexual Encounter Profile question 3 (SEP 3) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
International Index of Erectile Function (IIEF) - EF (Erectile Function) domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	739
Study Start Date:	June 2003
Study Completion Date:	January 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 10 mg Vardenafil to be taken 1 h prior to sexual attempt
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:

Heterosexual males
>/= 18 years old with ED for more than six months
Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

Exclusion Criteria:

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 the Summary of Product Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661297

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	100536
Study First Received:	April 15, 2008
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00661297 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