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Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
This study is currently recruiting participants.
Verified by Bayer, June 2009
First Received: August 19, 2008   Last Updated: June 23, 2009   History of Changes
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

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)

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:
  • 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
Recruiting
Berlin, Germany, 12107
Not yet recruiting
Berlin, Germany, 14197
Recruiting
Hamburg, Germany, 20354
Germany, Bayern
Recruiting
Regensburg, Bayern, Germany, 93055
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
Recruiting
Grevenbroich, Nordrhein-Westfalen, Germany, 41515
Recruiting
Wuppertal, Nordrhein-Westfalen, Germany, 42103
Recruiting
Leverkusen, Nordrhein-Westfalen, Germany, 51373
Germany, Rheinland-Pfalz
Recruiting
Trier, Rheinland-Pfalz, Germany, 54290
Recruiting
Koblenz, Rheinland-Pfalz, Germany, 56068
Not yet recruiting
Dierdorf, Rheinland-Pfalz, Germany, 56269
Germany, Saarland
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

Additional 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
Click here to find results for studies related to marketed products  This link exits the ClinicalTrials.gov site

No publications provided

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: June 23, 2009
ClinicalTrials.gov Identifier: NCT00738400     History of Changes
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
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
 Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Disease
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
 Pathologic Processes
Sexual Dysfunction, Physiological
Vardenafil
Phosphodiesterase Inhibitors
Mental Disorders
Syndrome
Erectile Dysfunction

ClinicalTrials.gov processed this record on September 11, 2009



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