Status:
COMPLETED
Testosterone Treatment for Multiple Sclerosis
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Multiple Sclerosis Society
Conditions:
Multiple Sclerosis
Eligibility:
MALE
18-65 years
Phase:
PHASE1
PHASE2
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 treatme...
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 ...
Eligibility Criteria
Inclusion
- Men, age 18-65, with a diagnosis of clinically definite relapsing remitting multiple sclerosis.
- Relapsing remitting patients who have declined or not tolerated treatment with beta interferon (Betaseron, Avonex) or glatiramer acetate, copolymer-1 (Copaxone).
- 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).
- Not in an intercurrent relapse.
- Expanded Disability Status Score (EDSS) = 0.0 to 5.0.
- The patients must have a significant T2 burden of disease on screening cerebral MRI as defined by T2 lesion loads greater than 7.5cm3.
- Must live within 100 miles of UCLA.
- 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
- Males unable to fulfill the above criteria and all female patients.
- 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.
- Males who have taken DHEA during the 3 months prior to study.
- 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).
- 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).
- Patients with testicular mass on exam.
- Patients with hematocrit greater than 50%
- Patients with major psychiatric illness (e.g. manic depressive states, schizophrenia)
- Patients with active alcoholism.
- Patients with a history of drug abuse within the past five years.
- Patients who are greater than 130% or less than 80% of their ideal body weight based on Metropolitan Life Tables.
- Patients with generalized skin disease that may effect absorption of testosterone (e.g. psoriasis) or a known skin intolerance to alcohol.
- Patients with prolactin \> 40 mcg/L.
- Patients with a cholesterol level greater than 300 mg/dl.
- Patients with other conditions that would interfere with assessing neurologic functions such as deforming arthritis or a major amputation.
- 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
- Patients who have received treatment with azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin A or experimental therapies in the six months preceding enrollment.
- Patients who have been treated with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine or bone marrow transplantation.
- Patients who have positive titers to HIV1,2; HTLV1; or VDRL.
- Patients who have clinical evidence of Lyme disease.
- 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.
- Patients with certain artificial heart valves, pacemakers, or other metallic/electronic material in their bodies.
- Patients with known hypersensitivity to gadolinium-DPTA.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00405353
Start Date
April 1 2002
End Date
March 1 2007
Last Update
November 22 2019
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095