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Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vardenafil (Levitra, 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, Traumatic spinal cord injury, Vardenafil

Eligibility Criteria

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

Inclusion Criteria:

  • Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period.
  • Stable heterosexual relationship for at least 1 month.

Exclusion Criteria:

  • Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications
  • 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 US Product Information or 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

    International Index of Erectile Function-Erectile Function domain

    Secondary Outcome Measures

    Sexual Encounter Profile Question 2
    Sexual Encounter Profile Question 3
    Other diary based variables
    Safety and tolerability

    Full Information

    First Posted
    April 4, 2008
    Last Updated
    September 26, 2013
    Sponsor
    Bayer
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00654680
    Brief Title
    Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury
    Official Title
    A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    January 2004 (Actual)
    Study Completion Date
    January 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
    Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    418 (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)
    Vardenafil (Levitra, BAY38-9456)
    Intervention Description
    5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo
    Primary Outcome Measure Information:
    Title
    International Index of Erectile Function-Erectile Function domain
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Sexual Encounter Profile Question 2
    Time Frame
    12 weeks
    Title
    Sexual Encounter Profile Question 3
    Time Frame
    12 weeks
    Title
    Other 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: Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period. Stable heterosexual relationship for at least 1 month. Exclusion Criteria: Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications 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 US Product Information or 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

    Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

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