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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

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 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


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



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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668096     History of Changes
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:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Phosphodiesterase 5 Inhibitors
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents