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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

April 24, 2008
June 29, 2009
May 2004
 
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 ]
Same as current
Complete list of historical versions of study NCT00668096 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
 
 
A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
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.

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.
 
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • Drug: Levitra (Vardenafil, BAY38-9456)
    Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
  • Drug: Placebo
    Matching Placebo
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
  • Experimental: Arm 1
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
January 2005
 

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
Male
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   Finland,   France,   Germany,   Spain,   United Kingdom
 
NCT00668096
11334
No
Therapeutic Area Head, Bayer HealthCare AG
Bayer
 
Study Director: Bayer Study Director Bayer
Bayer
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP