Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004131

Trial Description

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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)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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)

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004131
  •   2012/10/16
  •   2008/08/19
  •   no
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Secondary IDs

  •   2008-002140-41 
  •   NCT00738400  (ClinicalTrials.gov)
  •   13171  (Bayer)
  •   ED-METABOLIC 
  •   2008-002140-41 
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Health Condition or Problem studied

  •   Erectile Dysfunction
  •   Metabolic Syndrome
  •   N48.4 -  Impotence of organic origin
  •   E88.9 -  Metabolic disorder, unspecified
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Interventions/Observational Groups

  •   Drug: Vardenafil (Levitra, BAY38-9456)
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
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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); 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.
- 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.
- 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.

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Secondary Outcome

- 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')
- 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.
- 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.
- 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2008/11/30
  •   150
  •   Multicenter trial
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Inclusion Criteria

  •   Male
  •   18   Years
  •   64   Years
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Additional 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

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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

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2009/10/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.