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

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

ChemIDplus related topics:

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:	October 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 n/a	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 n/a	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, Bayern / 280
		Not yet recruiting
	Regensburg, Bayern / 280, Germany, 93055

Germany, Berlin / 285
		Not yet recruiting
	Berlin, Berlin / 285, Germany, 12107
		Not yet recruiting
	Berlin, Berlin / 285, Germany, 14197

Germany, Hamburg / 287
		Not yet recruiting
	Hamburg, Hamburg / 287, Germany, 20354

Germany, Hessen / 307
		Not yet recruiting
	Frankfurt, Hessen / 307, Germany, 60385
		Not yet recruiting
	Marburg, Hessen / 307, Germany, 35039

Germany, Nordrhein-Westfalen / 331
		Not yet recruiting
	Leverkusen, Nordrhein-Westfalen / 331, Germany, 51373

Germany, Nordrhein-Westfalen / 481
		Not yet recruiting
	Muelheim, Nordrhein-Westfalen / 481, Germany, 45468

Germany, Nordrhein-Westfalen / 616
		Not yet recruiting
	Wuppertal, Nordrhein-Westfalen / 616, Germany, 42103

Germany, Nordrhein-Westfalen / 623
		Not yet recruiting
	Grevenbroich, Nordrhein-Westfalen / 623, Germany, 41515

Germany, Rheinland-Pfalz / 381
		Not yet recruiting
	Trier, Rheinland-Pfalz / 381, Germany, 54290
		Not yet recruiting
	Koblenz, Rheinland-Pfalz / 381, Germany, 56068
		Not yet recruiting
	Dierdorf, Rheinland-Pfalz / 381, Germany, 56269

Germany, Saarland / 305
		Not yet recruiting
	Homburg, Saarland / 305, Germany, 66424

Germany, Sachsen / 313
		Not yet recruiting
	Leipzig, Sachsen / 313, Germany, 04109

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More 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 which might have occurred with this product This link exits the ClinicalTrials.gov site

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Responsible Party:	Bayer Vital GmbH ( Therapeutic Area Head )
Study ID Numbers:	13171, 2008-002140-41, ED-METABOLIC
First Received:	August 19, 2008
Last Updated:	October 7, 2008
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 October 15, 2008

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