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

December 23, 2014 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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, 13009
      • Marseille, France, 13015
      • Marseille, France, 13013
      • Montpellier, France, 34000
  • Germany
      • Hamburg, Germany, 22177
      • Hamburg, Germany, 22299
      • Hamburg, Germany, 22303
    • Sachsen
      • Dresden, Sachsen, Germany, 01129
      • Leipzig, Sachsen, Germany, 04249
      • Leipzig, Sachsen, Germany, 04105
      • Leisnig, Sachsen, Germany, 04703
      • Meißen, Sachsen, Germany, 01662
    • Schleswig-Holstein
      • Harrislee, Schleswig-Holstein, Germany, 24955
      • Norderstedt, Schleswig-Holstein, Germany, 22846
      • Wahlstedt, Schleswig-Holstein, Germany, 23812
    • Thüringen
      • Altenburg, Thüringen, Germany, 04600
  • Spain
      • Barcelona, Spain, 08032
    • Barcelona
      • Gavà, Barcelona, Spain, 08850
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08905
    • Cataluña
      • Badalona (Barcelona), Cataluña, Spain, 08043
  • United Kingdom
    • East Sussex
      • Crowborough, East Sussex, United Kingdom, TN6 1DL
    • Oxfordshire
      • Chipping Norton, Oxfordshire, United Kingdom, OX7 5AL
    • Staffordshire
      • Lichfield, Staffordshire, United Kingdom, WS14 9JL
    • Strathclyde
      • Hamilton, Strathclyde, United Kingdom, ML3 ODR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
PLACEBO_COMPARATOR: Arm 2
Drug: Placebo
Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 16 weeks
16 weeks
International Index of Erectile Function
Time Frame: 16 weeks
16 weeks
Treatment Satisfaction Scale
Time Frame: 16 weeks
16 weeks
Other patient diary based variables
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 27, 2008

First Posted (ESTIMATE)

April 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 25, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11334 (DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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