Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00738400
First received: August 19, 2008
Last updated: October 10, 2013
Last verified: October 2013
  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 4

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:


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 erectile dysfunction [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
Experimental: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00738400     History of Changes
Other Study ID Numbers: 13171, 2008-002140-41, ED-METABOLIC
Study First Received: August 19, 2008
Results First Received: November 26, 2010
Last Updated: October 10, 2013
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
Syndrome
Disease
Genital Diseases, Male
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Mental Disorders
Metabolic Diseases
Pathologic Processes
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Vardenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014