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Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 2
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

    Placebo Comparator

    Active Comparator

    Arm Label

    Arm 2

    Arm 1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Erectile Function domain of the International Index of Erectile Function
    Sexual Encounter Profile Question 2
    Sexual Encounter Profile Question 3

    Secondary Outcome Measures

    Erectile Function domain scores > 26
    Sexual Encounter Profile 2
    Global Assessment Question
    Reliability of insertion
    Reliability of maintenance
    Other subject diary based variables
    Safety and tolerability

    Full Information

    First Posted
    April 4, 2008
    Last Updated
    October 9, 2013
    Sponsor
    Bayer
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00656188
    Brief Title
    Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction
    Official Title
    A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    May 2003 (Actual)
    Study Completion Date
    May 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

    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 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    463 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 2
    Arm Type
    Placebo Comparator
    Arm Title
    Arm 1
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Levitra (Vardenafil, BAY38-9456)
    Intervention Description
    Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo
    Primary Outcome Measure Information:
    Title
    Erectile Function domain of the International Index of Erectile Function
    Time Frame
    12 weeks
    Title
    Sexual Encounter Profile Question 2
    Time Frame
    12 weeks
    Title
    Sexual Encounter Profile Question 3
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Erectile Function domain scores > 26
    Time Frame
    12 weeks
    Title
    Sexual Encounter Profile 2
    Time Frame
    12 weeks
    Title
    Global Assessment Question
    Time Frame
    12 weeks
    Title
    Reliability of insertion
    Time Frame
    12 weeks
    Title
    Reliability of maintenance
    Time Frame
    12 weeks
    Title
    Other subject diary based variables
    Time Frame
    12 weeks
    Title
    Safety and tolerability
    Time Frame
    12 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

    Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

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