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

Sponsor:	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 (pro re nata)

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction Metabolic Syndrome

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF) [ Time Frame: baseline and up to 8 weeks or LOCF ] [ Designated as safety issue: No ]
The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.
Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.
Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.

Secondary Outcome Measures:

Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF) [ Time Frame: up to 8 weeks or LOCF ] [ Designated as safety issue: No ]
Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')
Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.
Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.
Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata)) [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: No ]
Number of participants with no recorded titration of Vardenafil after visit 3.

Enrollment:	150
Study Start Date:	November 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vardenafil (Levitra, BAY38-9456) Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks	Drug: Vardenafil (Levitra, BAY38-9456) Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks
Placebo Comparator: Placebo Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks	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 (International Diabetes Foundation)
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 (non-arteritic anterior ischemic optic neuropathy)
29 Additional Exclusion Criteria

Contacts and Locations

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

Locations

Germany

Cham, Bayern, Germany, 93413

Regensburg, Bayern, Germany, 93055

Frankfurt, Hessen, Germany, 60385

Marburg, Hessen, Germany, 35039

Stuhr, Niedersachsen, Germany, 28816

Bonn, Nordrhein-Westfalen, Germany, 53119

Grevenbroich, Nordrhein-Westfalen, Germany, 41515

Leverkusen, Nordrhein-Westfalen, Germany, 51373

Mülheim, Nordrhein-Westfalen, Germany, 45468

Wuppertal, Nordrhein-Westfalen, Germany, 42103

Dierdorf, Rheinland-Pfalz, Germany, 56269

Koblenz, Rheinland-Pfalz, Germany, 56068

Trier, Rheinland-Pfalz, Germany, 54290

Homburg, Saarland, Germany, 66424

Dresden, Sachsen, Germany, 01307

Leipzig, Sachsen, Germany, 04109

Berlin, Germany, 14197

Berlin, Germany, 12107

Hamburg, Germany, 20354

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00738400 History of Changes
Other Study ID Numbers:	13171, EudraCT: 2008-002140-41, ED-METABOLIC
Study First Received:	August 19, 2008
Results First Received:	November 26, 2010
Last Updated:	June 10, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Vardenafil
Erectile Dysfunction
Double-blind study

Additional relevant MeSH terms:

Erectile Dysfunction
Metabolic Syndrome X
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

Metabolic Diseases
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012