Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004098

Trial Description

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Title

A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Compare once daily vs on demand treatment in men with erectile dysfunction.

Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks
+ 4 weeks wash-out:

A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at
bedtime for 24 weeksC: PRN for 24 weeks

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004098
  •   2012/08/09
  •   2008/02/25
  •   no
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Secondary IDs

  •   2005-001678-28 
  •   NCT00786253  (ClinicalTrials.gov)
  •   11875  (Bayer)
  •   RESTORE 
  •   EudraCT No: 2005-001678-28 
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Health Condition or Problem studied

  •   Erectile Dysfunction
  •   N48.4 -  Impotence of organic origin
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Interventions/Observational Groups

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

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
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  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF); time frame: 12- 24 weeks

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Secondary Outcome

- SEP 2; time frame: 12- 24 weeks
- SEP 3; time frame: 12- 24 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2005/10/31
  •   225
  •   Multicenter trial
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Inclusion Criteria

  •   Male
  •   18   Years
  •   64   Years
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Additional Inclusion Criteria

- Males 18-64 years of age

- Mild or mild to moderate ED (defined as >15 and <21 score points according to the
Erectile Function Domain Score from IIEF as assessed at the randomisation visit)

- History of at least one of the following conditions: Diabetes mellitus type 2,
hypertension, peripheral arterial occlusive disease

- Stable, heterosexual relationship for more than six months

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Exclusion Criteria

- Primary hypoactive sexual desire

- History of myocardial infarction, stroke or life-threatening arrhythmia within prior
6 month

- Nitrate therapy.

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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
  •   2007/01/01
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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.