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Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia

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 Male Erectile Dysfunction, Dyslipidemia, Vardenafil

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Males with ED for more than 6 months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
  • Stable heterosexual relationship for more than 6 months
  • Between 18 and <65 years of age
  • Diagnosed dyslipidemia and treated with a stable dose of a statin (or generic equivalent) >/=3 months at Screening. In addition, the subject must have remained on this stable dose of statin (or its generic equivalent) throughout the study and no additional therapy to treat dyslipidemia was initiated
  • InternationaI Index of Erectile Function - Erectile Function domain score of <25, denoting mild to severe ED at Visit 2

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 US Product Information

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 2 and 3 and International Index of Erectile Function - Erectile Function domain

    Secondary Outcome Measures

    Duration of erection leading to positive Sexual Encounter Profile Question 3
    Safety and tolerability
    Other patient diary based variables

    Full Information

    First Posted
    April 17, 2008
    Last Updated
    October 10, 2013
    Sponsor
    Bayer
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00663845
    Brief Title
    Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia
    Official Title
    A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is being conducted in US to obtain information on the efficacy, safety, and duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy medication with no pharmacological activity), in patients with co-morbid factors associated with erectile dysfunction (also called impotence). The duration of erection endpoint will be assessed by patient utilized stopwatch timings during each attempt at sexual intercourse. Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug Administration for the treatment of erectile dysfunction. While there is no intent to assess the effect vardenafil has on blood lipids, the study will provide prospective data on men diagnosed with both ED and dyslipidemia.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    395 (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 Vardenafil taken orally 1h prior to sexual intercourse
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo
    Primary Outcome Measure Information:
    Title
    Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Duration of erection leading to positive Sexual Encounter Profile Question 3
    Time Frame
    12 weeks
    Title
    Safety and tolerability
    Time Frame
    12 weeks
    Title
    Other patient diary based variables
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males with ED for more than 6 months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) Stable heterosexual relationship for more than 6 months Between 18 and <65 years of age Diagnosed dyslipidemia and treated with a stable dose of a statin (or generic equivalent) >/=3 months at Screening. In addition, the subject must have remained on this stable dose of statin (or its generic equivalent) throughout the study and no additional therapy to treat dyslipidemia was initiated InternationaI Index of Erectile Function - Erectile Function domain score of <25, denoting mild to severe ED at Visit 2 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 US Product Information
    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

    Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia

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