search
Back to results

A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
testosterone
placebo gel
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers
Inclusion Criteria: Men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised McDonald Criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Testosterone gel

    Placebo gel

    Arm Description

    Apply gel once a day for 96 weeks

    Apply gel once a day for 96 weeks

    Outcomes

    Primary Outcome Measures

    Whole Brain Atrophy

    Secondary Outcome Measures

    Full Information

    First Posted
    December 3, 2014
    Last Updated
    August 2, 2016
    Sponsor
    University of California, Los Angeles
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02317263
    Brief Title
    A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    NIH did not fund the study so it never started
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    January 2099 (Anticipated)
    Study Completion Date
    January 2099 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Los Angeles

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a multicenter, prospective, placebo-controlled, double-blind randomized Phase II clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96 weeks duration on whole brain atrophy in men with MS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    MS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Testosterone gel
    Arm Type
    Active Comparator
    Arm Description
    Apply gel once a day for 96 weeks
    Arm Title
    Placebo gel
    Arm Type
    Placebo Comparator
    Arm Description
    Apply gel once a day for 96 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    testosterone
    Intervention Type
    Drug
    Intervention Name(s)
    placebo gel
    Primary Outcome Measure Information:
    Title
    Whole Brain Atrophy
    Time Frame
    96 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised McDonald Criteria

    12. IPD Sharing Statement

    Learn more about this trial

    A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis

    We'll reach out to this number within 24 hrs