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Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Vardenafil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • Stable sexual relationship for > 6 month.

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm 1

    Arm 2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Per-patient success rates based on Sexual Encounter Profile, Question 3

    Secondary Outcome Measures

    Per-subject success rates based on Sexual Encounter Profile, Question 2
    International Index of Erectile Function- Erectile Function domain score
    Global Assessment Question (GAQ)
    Safety and tolerability

    Full Information

    First Posted
    April 18, 2008
    Last Updated
    October 10, 2013
    Sponsor
    Bayer
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00682019
    Brief Title
    Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
    Official Title
    A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bayer
    Collaborators
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erectile Dysfunction
    Keywords
    Erectile Dysfunction, Vardenafil

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    383 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Title
    Arm 2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Levitra (Vardenafil, BAY38-9456)
    Intervention Description
    5mg, 10mg or 20mg taken 8 hours before sexual intercourse
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    matching placebo
    Primary Outcome Measure Information:
    Title
    Per-patient success rates based on Sexual Encounter Profile, Question 3
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Per-subject success rates based on Sexual Encounter Profile, Question 2
    Time Frame
    10 weeks
    Title
    International Index of Erectile Function- Erectile Function domain score
    Time Frame
    10 weeks
    Title
    Global Assessment Question (GAQ)
    Time Frame
    10 weeks
    Title
    Safety and tolerability
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, History of unresponsiveness to sildenafil Stable sexual relationship for > 6 month. Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

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