A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
NCT ID: NCT00668096
Last Updated: 2014-12-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
260 participants
INTERVENTIONAL
2004-05-31
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 2
Placebo
Matching Placebo
Arm 1
Levitra (Vardenafil, BAY38-9456)
Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
Interventions
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Levitra (Vardenafil, BAY38-9456)
Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
Placebo
Matching Placebo
Eligibility Criteria
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Inclusion Criteria
* Heterosexual relationship for more than 6 months
* Partner willing to complete the TSS
Exclusion Criteria
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Nitrate use
18 Years
64 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Bruxelles - Brussel, , Belgium
Drieslinter, , Belgium
Genk, , Belgium
Leuven, , Belgium
Gentofte Municipality, , Denmark
Næstved, , Denmark
Svendborg, , Denmark
Viborg, , Denmark
Kerava, , Finland
Oulu, , Finland
Tampere, , Finland
Grenoble, , France
Lille, , France
Lyon, , France
Marseille, , France
Marseille, , France
Marseille, , France
Montpellier, , France
Hamburg, City state of Hamburg, Germany
Hamburg, City state of Hamburg, Germany
Hamburg, City state of Hamburg, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Leipzig, Saxony, Germany
Leisnig, Saxony, Germany
Meissen, Saxony, Germany
Harrislee, Schleswig-Holstein, Germany
Norderstedt, Schleswig-Holstein, Germany
Wahlstedt, Schleswig-Holstein, Germany
Altenburg, Thuringia, Germany
Barcelona, Barcelona, Spain
Gavà, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Badalona (Barcelona), Catalonia, Spain
Crowborough, East Sussex, United Kingdom
Chipping Norton, Oxfordshire, United Kingdom
Lichfield, Staffordshire, United Kingdom
Hamilton, Strathclyde, United Kingdom
Countries
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Other Identifiers
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11334
Identifier Type: -
Identifier Source: org_study_id