Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010319

Trial Description

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Title

A Randomized, Open-label, Multi-center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia

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Trial Acronym

LUTECIA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes,
hypertension or hyperlipidemia

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00010319
  •   2016/04/20
  •   2008/04/24
  •   no
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Secondary IDs

  •   NCT00668109  (ClinicalTrials.gov)
  •   10893  (Bayer)
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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: Tadalafil
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group; time frame: 4 weeks

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Secondary Outcome

- Sexual encounter profile question 2; time frame: 4 weeks
- Hardness of erection; time frame: 4 weeks
- Other diary based variables; time frame: 4 weeks
- Safety and tolerability; time frame: 4 weeks

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Countries of Recruitment

  •   Belgium
  •   Colombia
  •   Finland
  •   Germany
  •   Israel
  •   Italy
  •   Mexico
  •   Netherlands
  •   Norway
  •   Peru
  •   South Africa
  •   Spain
  •   Sweden
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Locations of Recruitment

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Recruitment

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  •   2003/12/31
  •   614
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Age: 18 years and older- Males with erectile dysfunction- Stable
heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or
hypertension and/or hyperlipidemia

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Exclusion Criteria

- Primary hypoactive sexual desire-
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6
months- Nitrate use- Other exclusion criteria apply according to Summary of Product
Characteristics

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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
  •   2004/06/01
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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 .
  •   2
  •   2016/07/17


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