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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02317263
Recruitment Status : Withdrawn (NIH did not fund the study so it never started)
First Posted : December 15, 2014
Last Update Posted : August 4, 2016
Information provided by (Responsible Party):
University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: testosterone Drug: placebo gel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Estimated Primary Completion Date : January 2099
Estimated Study Completion Date : January 2099

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Testosterone gel
Apply gel once a day for 96 weeks
Drug: testosterone
Placebo Comparator: Placebo gel
Apply gel once a day for 96 weeks
Drug: placebo gel

Primary Outcome Measures :
  1. Whole Brain Atrophy [ Time Frame: 96 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Inclusion Criteria: Men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised McDonald Criteria
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Responsible Party: University of California, Los Angeles Identifier: NCT02317263    
Other Study ID Numbers: U01NS089369
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Keywords provided by University of California, Los Angeles:
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs