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Testosterone Treatment for 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.
 
ClinicalTrials.gov Identifier: NCT00405353
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Rhonda Voskuhl, University of California, Los Angeles

Brief Summary:
Since men are less likely to develop multiple sclerosis, the hypothesis was that testosterone might be protective in MS. Men with MS for followed untreated for 6 months, followed by a 12 month treatment period with Androgel.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Androgel 10 grams of gel containing 100 mg of testosterone Phase 1 Phase 2

Detailed Description:

Background: Men are less susceptible to many autoimmune diseases including multiple sclerosis (MS). Possible causes for this include sex hormones and/or sex chromosome effects. Testosterone treatment ameliorates experimental allergic encephalomyelitis (EAE), an animal model of MS, but the effect of testosterone supplementation on men with MS is not known.

Design, Setting and Participants: Ten men with relapsing remitting MS were studied using a crossover design whereby each patient served as his own control. There was a six-month pretreatment period followed by a twelve month period of daily treatment with 100mg of testosterone gel.

Main Outcome Measures: Brain atrophy and Cognitive testing

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testosterone Treatment for Multiple Sclerosis: A Preliminary Trial
Study Start Date : April 2002
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007


Arm Intervention/treatment
Experimental: crossover treatment with Androgel
6 months pretreatment, 12 months treatment intervention with Androgel 10 grams of gel containing 100mg of testosterone
Drug: Androgel 10 grams of gel containing 100 mg of testosterone
testosterone gel
Other Name: testosterone




Primary Outcome Measures :
  1. Whole Brain Atrophy Rate [ Time Frame: Baseline and 12 months ]
    as assessed by Voxel-Based Morphometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men, age 18-65, with a diagnosis of clinically definite relapsing remitting multiple sclerosis.
  2. Relapsing remitting patients who have declined or not tolerated treatment with beta interferon (Betaseron, Avonex) or glatiramer acetate, copolymer-1 (Copaxone).
  3. At least one relapse in the two years prior to entry. Relapse will be defined historically as definite worsening of a previous symptom (over 0-3 days) or development of a new symptom (over 0-3 days).
  4. Not in an intercurrent relapse.
  5. Expanded Disability Status Score (EDSS) = 0.0 to 5.0.
  6. The patients must have a significant T2 burden of disease on screening cerebral MRI as defined by T2 lesion loads greater than 7.5cm3.
  7. Must live within 100 miles of UCLA.
  8. Must be willing and able to receive an initial screening cerebral MRI, a baseline MRI and monthly cerebral MRIs (with and without gadolinium) for a total period of 12 months (6 months prior to treatment and 6 months during treatment).

Exclusion Criteria:

  1. Males unable to fulfill the above criteria and all female patients.
  2. Males who have been on sex hormone treatment including androgens, estrogens, or anti-estrogens for hypogonadism or other medical condition during the 12 months prior to study.
  3. Males who have taken DHEA during the 3 months prior to study.
  4. Patients who have thrombosis, serious cardiac, pulmonary, renal, gastrointestinal, hepatic, immunologic, infectious, neoplastic (with particular focus on patients with known or suspected estrogen or testosterone-dependent tumors), or urologic disease (with a particular focus on patients with a history of prostatic hypertrophy/nodules).
  5. Patients with an abnormal prostate as evidenced by prostatic masses or induration on rectal examination or prostate ultrasonography or elevated levels of prostatic specific antigen (PSA 4 ng/ml or higher).
  6. Patients with testicular mass on exam.
  7. Patients with hematocrit greater than 50%
  8. Patients with major psychiatric illness (e.g. manic depressive states, schizophrenia)
  9. Patients with active alcoholism.
  10. Patients with a history of drug abuse within the past five years.
  11. Patients who are greater than 130% or less than 80% of their ideal body weight based on Metropolitan Life Tables.
  12. Patients with generalized skin disease that may effect absorption of testosterone (e.g. psoriasis) or a known skin intolerance to alcohol.
  13. Patients with prolactin > 40 mcg/L.
  14. Patients with a cholesterol level greater than 300 mg/dl.
  15. Patients with other conditions that would interfere with assessing neurologic functions such as deforming arthritis or a major amputation.
  16. Patients who have received treatment with beta interferon (Betaseron or Avonex), glatiramer acetate copolymer-1 (Copaxone), ACTH, corticosteroids, intravenous immunoglobulins (IVIG), or plasma exchange in the three months preceding enrollment
  17. Patients who have received treatment with azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin A or experimental therapies in the six months preceding enrollment.
  18. Patients who have been treated with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine or bone marrow transplantation.
  19. Patients who have positive titers to HIV1,2; HTLV1; or VDRL.
  20. Patients who have clinical evidence of Lyme disease.
  21. Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.
  22. Patients with certain artificial heart valves, pacemakers, or other metallic/electronic material in their bodies.
  23. Patients with known hypersensitivity to gadolinium-DPTA.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405353


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Rhonda Voskuhl, M.D. University of California, Los Angeles
Publications of Results:
Other Publications:
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Responsible Party: Rhonda Voskuhl, Professor, Department of Neurology; Director Multiple Sclerosis Program, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00405353    
Other Study ID Numbers: RG 3239
First Posted: November 30, 2006    Key Record Dates
Results First Posted: November 22, 2019
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhonda Voskuhl, University of California, Los Angeles:
multiple sclerosis
testosterone
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents