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A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy. (FINDER)

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ClinicalTrials.gov Identifier: NCT00668096
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 25, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.
Study Start Date : May 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Arm 2 Drug: Placebo
Matching Placebo
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity


Outcome Measures
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Primary Outcome Measures :
  1. Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. International Index of Erectile Function [ Time Frame: 16 weeks ]
  2. Treatment Satisfaction Scale [ Time Frame: 16 weeks ]
  3. Other patient diary based variables [ Time Frame: 16 weeks ]
  4. Safety and tolerability [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
  • Heterosexual relationship for more than 6 months
  • Partner willing to complete the TSS

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 the Summary of Product Characteristics
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668096


Locations
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Belgium
Bruxelles - Brussel, Belgium, 1000
Drieslinter, Belgium, 3350
Genk, Belgium, 3600
Leuven, Belgium, 3000
Denmark
Gentofte, Denmark, DK-2820
Naestved, Denmark, 4700
Svendborg, Denmark, DK-5700
Viborg, Denmark, 8800
Finland
Kerava, Finland, 04250
Oulu, Finland, 90100
Tampere, Finland, 33100
France
Grenoble, France, 38000
Lille, France, 59000
Lyon, France, 69000
Marseille, France, 13009
Marseille, France, 13013
Marseille, France, 13015
Montpellier, France, 34000
Germany
Dresden, Sachsen, Germany, 01129
Leipzig, Sachsen, Germany, 04105
Leipzig, Sachsen, Germany, 04249
Leisnig, Sachsen, Germany, 04703
Meißen, Sachsen, Germany, 01662
Harrislee, Schleswig-Holstein, Germany, 24955
Norderstedt, Schleswig-Holstein, Germany, 22846
Wahlstedt, Schleswig-Holstein, Germany, 23812
Altenburg, Thüringen, Germany, 04600
Hamburg, Germany, 22177
Hamburg, Germany, 22299
Hamburg, Germany, 22303
Spain
Gavà, Barcelona, Spain, 08850
L'Hospitalet de Llobregat, Barcelona, Spain, 08905
Badalona (Barcelona), Cataluña, Spain, 08043
Barcelona, Spain, 08032
United Kingdom
Crowborough, East Sussex, United Kingdom, TN6 1DL
Chipping Norton, Oxfordshire, United Kingdom, OX7 5AL
Lichfield, Staffordshire, United Kingdom, WS14 9JL
Hamilton, Strathclyde, United Kingdom, ML3 ODR
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668096    
Other Study ID Numbers: 11334
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Erectile Dysfunction
PDE5 inhibitors
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
 Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents