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

November 12, 2015 updated by: Bayer

Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14197
      • Berlin, Germany, 12107
      • Hamburg, Germany, 20354
    • Bayern
      • Cham, Bayern, Germany, 93413
      • Regensburg, Bayern, Germany, 93055
    • Hessen
      • Frankfurt, Hessen, Germany, 60385
      • Marburg, Hessen, Germany, 35039
    • Niedersachsen
      • Stuhr, Niedersachsen, Germany, 28816
    • Nordrhein-Westfalen
      • 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
    • Rheinland-Pfalz
      • Dierdorf, Rheinland-Pfalz, Germany, 56269
      • Koblenz, Rheinland-Pfalz, Germany, 56068
      • Trier, Rheinland-Pfalz, Germany, 54290
    • Saarland
      • Homburg, Saarland, Germany, 66424
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
baseline and up to 8 weeks or LOCF
Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
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
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.
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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')
up to 8 weeks or LOCF
Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8
Time Frame: Baseline and 8 weeks
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.
Baseline and 8 weeks
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
Number of participants with no recorded titration of Vardenafil after visit 3.
week 4 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (ESTIMATE)

August 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2015

Last Update Submitted That Met QC Criteria

November 12, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13171
  • 2008-002140-41 (EUDRACT_NUMBER)
  • ED-METABOLIC (OTHER: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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