Testosterone Treatment for Multiple Sclerosis

Completed · Phase 1/Phase 2

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00405353

Run by

University of California, Los Angeles

People needed

10

Starts

2002-04-01

Expected to finish

2007-03-01

Last updated by the study team

2019-11-22

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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