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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00668096
First received: April 24, 2008
Last updated: June 29, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Erectile Dysfunction
 Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • International Index of Erectile Function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Other patient diary based variables [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 246
Study Start Date: May 2004
Study Completion Date: January 2005
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668096

  Hide Study Locations
Locations
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, 13015
Marseille, France, 13009
Marseille, France, 13013
Montpellier, France, 34000
Germany
Dresden, Sachsen, Germany, 01129
Leipzig, Sachsen, Germany, 04249
Leipzig, Sachsen, Germany, 04105
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, 22299
Hamburg, Germany, 22177
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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00668096     History of Changes
Other Study ID Numbers: 11334
Study First Received: April 24, 2008
Last Updated: June 29, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: National Health Service
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency

Keywords provided by Bayer:
Erectile Dysfunction
PDE5 inhibitors

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Phosphodiesterase 5 Inhibitors
 Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013