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Testosterone Treatment for Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00405353
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : July 12, 2013
Sponsor:
Collaborator:
Information provided by:

Study Description
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 100mg gel Phase 1 Phase 2

Detailed Description:
While testosterone (T) has been previously shown to be safe and well tolerated in hypogonadal males, it has not been previously given to male MS patients. This study will determine whether treatment with testosterone (T), as a percutaneous gel, is safe and well tolerated in male patients with relapsing MS through the following approach. Patients will be followed clinically and with serological studies 6 months prior to treatment to establish baseline data. Then, testosterone (T) gel will be administered daily at 100 mg per day for 6 months. Patients will continue to be followed clinically and with serological studies. Toxic effects of T gel treatment will become evident if patients change during treatment as compared to their baseline. To determine if T gel treatment induces a decrease in MS disease activity, the most sensitive measure will be used, the number and volume of gadolinium enhancing lesions and the volume of T2 lesions on serial cerebral magnetic resonance imaging (MRI). 12 patients will undergo MRI once a month, for 6 consecutive months, before starting treatment to establish their baseline level of disease activity on MRI. Then these 12 patients will be treated with T gel for 6 months. Patients will continue to undergo serial MRI once a month, for 6 more consecutive months, while on treatment. In this manner, the level of disease activity during treatment can be compared to the level of disease activity before treatment. Patients will also be followed with standard neurological exams (every 3 months), however it is hypothesized that, with only 6 months of treatment, no effect of T gel treatment will be observed on clinical disease activity (disability, relapse rate) since this is a less sensitive measure. Further, to determine whether T gel treatment induces desired effects in the immune system, immune responses will be assessed before treatment and during treatment. Results of in vivo (delayed type hypersensitivity) and in vitro (cytokine production) responses will be compared before treatment with those during treatment. Finally, since T gel therapy at this dose of 100 mg/day has been shown to improve sexual function and mood, increase lean body mass and strength, decrease body fat and increase bone mineral density, we will monitor whether these positive effects also occur in men with MS during treatment.

Study Design

Study Type : Observational
Estimated Enrollment : 10 participants
Time Perspective: Prospective
Official Title: Testosterone Treatment for Multiple Sclerosis: A Preliminary Trial
Study Start Date : April 2002
Estimated Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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.
Contacts and Locations

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
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
Principal Investigator: Rhonda Voskuhl, M.D. University of California, Los Angeles
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00405353     History of Changes
Other Study ID Numbers: RG 3239
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: November 2006

Keywords provided by University of California, Los Angeles:
multiple sclerosis
testosterone

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents