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Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 4
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 - 64 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men >/= 18 years of age
  • ED >/= 6 months
  • Stable sexual relationship for > 6 months

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy
  • Other exclusion criteria apply according to the Summary of Product Characteristics

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

    Sexual encounter profile Question 3

    Secondary Outcome Measures

    Safety and Tolerability

    Full Information

    First Posted
    April 24, 2008
    Last Updated
    June 29, 2009
    Sponsor
    Bayer
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00667979
    Brief Title
    Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
    Official Title
    A Pilot, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Vardenafil Versus Placebo Administered 12, 18 and 24 Hours Prior to Initiation of Sexual Intercourse in Subjects With ED
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Bayer
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.

    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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    264 (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
    10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo
    Primary Outcome Measure Information:
    Title
    Sexual encounter profile Question 3
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Safety and Tolerability
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men >/= 18 years of age ED >/= 6 months Stable sexual relationship for > 6 months Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy Other exclusion criteria apply according to the Summary of Product Characteristics
    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

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