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| Sponsor: | University of California, Los Angeles |
|---|---|
| Collaborator: |
National Multiple Sclerosis Society |
| Information provided by: | University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00405353 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Androgel 100mg gel |
Phase I Phase II |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Testosterone Treatment for Multiple Sclerosis: A Preliminary Trial |
| Estimated Enrollment: | 10 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | March 2004 |
While testosterone (T) has been previously shown to be safe and well tolerated in hypogonadol 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | Rhonda Voskuhl, M.D. | University of California, Los Angeles |
More Information
| Study ID Numbers: | RG 3239 |
| Study First Received: | November 28, 2006 |
| Last Updated: | November 29, 2006 |
| ClinicalTrials.gov Identifier: | NCT00405353 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
multiple sclerosis testosterone |
|
Autoimmune Diseases Antineoplastic Agents, Hormonal Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Sclerosis Methyltestosterone Hormones |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Multiple Sclerosis Pathologic Processes Therapeutic Uses Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Androgens |