check_circleStudy Completed

Erectile Dysfunction, Metabolic Syndrome

Bayer Identifier:

13171

ClinicalTrials.gov Identifier:

NCT00738400

EudraCT Number:

2008-002140-41

EU CT Number:

Not Available
Study of vardenafil in patients suffering from erectile dysfunction and metabolic syndrome

Trial 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)

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
150
Trial Dates
November 2008 - October 2009
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Drs. Tim Schneider /B. SchneiderMülheim, 45468, Germany
Completed
Praxis Drs. F. Merfort / M. Stammen / S. van HaagGrevenbroich, 41515, Germany
Completed
Praxis Klunder/Stephan-OdenthalLeverkusen, 51373, Germany
Terminated
Praxis Hr. Dr. G. BöhmBonn, 53119, Germany
Completed
Praxis Hr. Dr. M. IndigTrier, 54290, Germany
Completed
Praxis Hr. Dr. A. von KeitzMarburg, 35039, Germany
Terminated
Praxis Drs. Böhm & LinnèDresden, 01307, Germany
Completed
Praxis Hr. Dr. J. GleißnerWuppertal, 42103, Germany
Completed
Praxis Drs. Netzer/SachseHomburg, 66424, Germany
Completed
Praxis Drs. Popp/HanikaRegensburg, 93055, Germany
Terminated
Praxis Drs. Bickeböller & Rachel GbRFrankfurt, 60385, Germany
Completed
Praxis Hr. Dr. A. RollenhagenBerlin, 12107, Germany
Terminated
Urologische GemeinschaftspraxisBerlin, 14197, Germany
Completed
Praxis Hr. Dr. H.-P. FischerKoblenz, 56068, Germany
Completed
Praxis Hr. Prof. Dr. H. PorstHamburg, 20354, Germany
Terminated
Praxis Hr. Dr. R. OstwaldDierdorf, 56269, Germany
Completed
Praxis Hr. Dr. J. WillgerodtLeipzig, 04109, Germany
Completed
Gemeinschaftspraxis Dres. M. Brandl, M. Fichtlscherer,Cham, 93413, Germany
Completed
Praxisgemeinschaft Stuhr-BrinkumStuhr, 28816, Germany

Primary Outcome

  • Change from baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) subscore at week 8 or last observation carried forward (LOCF)
    date_rangeTime Frame:
    baseline and up to 8 weeks or LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change in percentage from baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at week 8
    date_rangeTime Frame:
    Baseline and 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in percentage from baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at week 8
    date_rangeTime Frame:
    Baseline and 8 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of participants achieving "Back to Normal" Erectile Function at week 8 or last observation carried forward (LOCF)
    date_rangeTime Frame:
    up to 8 weeks or LOCF
    enhanced_encryption
    Safety Issue:
    No
  • Change in percentage from baseline in ability to obtain an erection (SEP1) at week 8
    date_rangeTime Frame:
    Baseline and 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in percentage from baseline in ability to ejaculation (SEP6) at week 8
    date_rangeTime Frame:
    Baseline and 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants who can stay on the initially provided dosage of Vardenafil (10 mg PRN (pro re nata))
    date_rangeTime Frame:
    week 4 and week 8
    enhanced_encryption
    Safety Issue:
    No

Trial design

Double-blind, placebo controlled, randomized study of vardenafil to determine efficacy on Erectile Dysfunction (ED) in men with ED and Metabolic Syndrome (ED-METABOLIC)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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