Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00738400

Purpose

This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN

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

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome ("ED-METABOLIC")

Further study details as provided by Bayer:

Primary Outcome Measures:

IIEF-EF Domain score at week 8 or LOCF compared with baseline [ Time Frame: at baseline, at week 4 and week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects achieving "back to normal" erectile function [ Time Frame: at week 8 or LOCF ] [ Designated as safety issue: No ]
All diary questions other than SEP 2 and 3 that concern erectile function that were assessed over the entire treatment period [ Time Frame: at screening, at baseline, at week 4 ] [ Designated as safety issue: No ]
Percentage of patients who can stay on the initially provided dosage of vardenafil (10 mg PRN) [ Time Frame: at week 4 and week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks
Arm 2: Placebo Comparator	Drug: Placebo Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Stable heterosexual relationship
History of erectile dysfunction for at least 6 months
IIEF- EF Domain entry score (at Visit 2): >21 points
Documented metabolic syndrome according to the IDF
Subjects motivated for erectile dysfunction treatment
Documented, dated, written informed consent

Exclusion Criteria:

Any underlying cardiovascular condition
History of myocardial infarction
Uncontrolled atrial fibrillation
Resting hypotension
Postural hypotension within 6 months of Visit 1
History of congenital QT prolongation
Bleeding disorder
History of prostatectomy because of prostate cancer
Hereditary degenerative retinal disorders
History of loss of vision because of NAION
29 Additional Exclusion Criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738400

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Germany
	Not yet recruiting
Berlin, Germany, 12107
	Not yet recruiting
Berlin, Germany, 14197
	Not yet recruiting
Hamburg, Germany, 20354
Germany, Bayern
	Recruiting
Regensburg, Bayern, Germany, 93055
	Not yet recruiting
Cham, Bayern, Germany, 93413
Germany, Hessen
	Not yet recruiting
Frankfurt, Hessen, Germany, 60385
	Recruiting
Marburg, Hessen, Germany, 35039
Germany, Niedersachsen
	Recruiting
Stuhr, Niedersachsen, Germany, 28816
Germany, Nordrhein-Westfalen
	Recruiting
Muelheim, Nordrhein-Westfalen, Germany, 45468
	Not yet recruiting
Grevenbroich, Nordrhein-Westfalen, Germany, 41515
	Not yet recruiting
Wuppertal, Nordrhein-Westfalen, Germany, 42103
	Not yet recruiting
Leverkusen, Nordrhein-Westfalen, Germany, 51373
Germany, Rheinland-Pfalz
	Not yet recruiting
Trier, Rheinland-Pfalz, Germany, 54290
	Recruiting
Koblenz, Rheinland-Pfalz, Germany, 56068
	Not yet recruiting
Dierdorf, Rheinland-Pfalz, Germany, 56269
Germany, Saarland
	Not yet recruiting
Homburg, Saarland, Germany, 66424
Germany, Sachsen
	Recruiting
Leipzig, Sachsen, Germany, 04109
	Not yet recruiting
Dresden, Sachsen, Germany, 01307

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	13171, EudraCT No: 2008-002140-41, ED-METABOLIC
Study First Received:	August 19, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00738400
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Vardenafil,
Erectile Dysfunction
Double-blind study

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Vardenafil
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Syndrome
Enzyme Inhibitors
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009