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
  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:


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

  Show 38 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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 April 23, 2014