Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003992

Trial Description

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Title

Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men With Erectile Dysfunction Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The primary objective of this study is to determine whether the use of PDE5 inhibitors
(vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.

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Brief Summary in Scientific Language

Collected data will be compared to historic data of the same participant in case-crossover
design.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003992
  •   2012/06/19
  •   2009/03/23
  •   no
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Secondary IDs

  •   2010-023586-22 
  •   NCT00867815  (ClinicalTrials.gov)
  •   12912  (Bayer)
  •   2010-023586-22 
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Health Condition or Problem studied

  •   Anterior Ischemic Optic Neuropathy
  •   H47.0 -  Disorders of optic nerve, not elsewhere classified
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Interventions/Observational Groups

  •   Drug: Diagnostic procedures
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Characteristics

  •   Interventional
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  •   Open (masking not used)
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  •   Other
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  •   Crossover
  •   IV
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Primary Outcome

- Confirmed diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION).; time frame: Up to 67 days prior to study enrollment

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Secondary Outcome

- Any additional safety information provided by the subject; time frame: At baseline and after 12 weeks

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Countries of Recruitment

  •   United States
  •   Australia
  •   Canada
  •   Germany
  •   Italy
  •   Mexico
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Locations of Recruitment

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Recruitment

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  •   2009/07/31
  •   284
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   40   Years
  •   no maximum age
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Additional Inclusion Criteria

- Sudden visual loss in 1 eye within 45 days before entry to the study

- History of erectile dysfunction at least 1 year prior to study enrollment

- At least 1 dose of PDE5 inhibitor(s) taken within a year prior to the onset of loss
of vision

- Age 40 years or older

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Exclusion Criteria

- History of multiple sclerosis or optic neuritis

- Evidence of temporal arteritis

- History of vasculitis or collagen vascular disease

- Previous history of NAION

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    •   [---]*
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    • Bayer Clinical Trials Contact 
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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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    •   [---]*
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Status

  •   Recruiting ongoing
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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 .
  •   7
  •   2016/01/14


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