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A Pilot Study of Testosterone Treatment for Men with Relapsing Remitting Multiple Sclerosis
Nancy L. Sicotte, Barbara S. Giesser, Vinita Tandon, Barbara Steiner, Ricki Klutch, Ann Drain, David W. Shattuck, Laura Hull, Ronald Swerdloff, Torrance, CA, Rhonda R. Voskuhl, Los Angeles, CA

OBJECTIVE: To determine the effect of testosterone treatment in men with relapsing remitting MS.

BACKGROUND: Men are less susceptible to many autoimmune diseases including multiple sclerosis but the reason is not known. Possibilities include sex hormone or sex chromosome effects. In men, the age at MS onset is later (30-40s) corresponding to the onset of decline in bioavailable testosterone. In addition, testosterone ameliorates disease severity in experimental autoimmune encephalomyelitis and other animal models of autoimmune disease. Testosterone may have direct neuroprotective effects and may be important in maintaining cognitive function. Whether testosterone treatment is beneficial for men with MS has not been studied previously.

DESIGN/METHODS: Eligible participants were men with relapsing remitting MS, off all immunomodulators. The study was a single crossover design with a six month observation period followed by twelve months of daily treatment with 100mg testosterone gel applied topically. The EDSS and MSFC were performed every 3 months during the 18 month study period. Other cognitive and quality of life measures were collected at 6 monthly intervals. Enhanced cerebral MRIs were performed monthly during the baseline and treatment periods.

RESULTS: At study onset, none of the ten subjects studied were hypogonadal. Testosterone treatment induced a 50% increase in testosterone levels on average and was well tolerated. Improvements were observed in PASAT performance and spatial memory tasks with treatment along with quality of life measures related to physical functioning. MRI inflammatory activity was relatively low in the group prior to treatment, with no increase in enhancing lesion numbers and volumes observed with treatment.

CONCLUSIONS/RELEVANCE: Testosterone treatment of men with RRMS is safe, well-tolerated and is associated with significant improvements in cognitive function. Further study of the use of testosterone treatment in RRMS in larger groups over longer time periods is warranted.

Supported by: National MS Society.Category - MS and Related DiseasesSubCategory - Clinical ScienceTuesday, April 4, 2006 7:30

Decreased Serum Testosterone Levels in Multiple Sclerosis
Elena V. Simon, Ilir Topalli, Amir Touray, Saud A. Sadiq, New York, NY

OBJECTIVE: To determine if serum testosterone levels are altered in multiple sclerosis (MS).

BACKGROUND: MS disease severity and progression is likely affected by several factors. Hormonal changes are implicated due to a higher incidence in females, disease amelioration in pregnancy, and apparent disease acceleration in post-menopausal women and older men. Because testosterone has neuroprotective and immunomodulatory effects and is protective in experimental autoimmune encephalomyelitis, we investigated whether testosterone levels are altered in MS.

DESIGN/METHODS: Total and free serum testosterone levels were obtained from 100 randomly selected clinically definite MS patients (68 females and 32 males). Patients were excluded if pregnant or nursing, taking hormone therapy or contraception, had infection, blood disorders, history of liver disease or recent steroid therapy. Patients were evaluated for disease activity. All analysis was double-blinded. Low testosterone levels were defined as 20 ng/dl in females and 295 ng/dl in males.

RESULTS: Thirty-nine of 68 females (57%) and 14 of 32 males (44%) had decreased serum testosterone levels. These testosterone levels are much lower than the values seen in a normal population where only 5% would be expected to have decreased levels. A significant correlation of testosterone levels with change in EDSS was not shown in our patients. However, in male patients with ongoing disease progression, 60% had low testosterone levels suggesting a trend towards increased disease activity with lowered hormone levels. Similarly, in females with normal testosterone levels only 33% showed evidence of disease progression in the preceeding year, whereas 54% with low testosterone levels had active disease.

CONCLUSIONS/RELEVANCE: Low testosterone levels occur in approximately 50% of patients with MS. In patients with low hormone levels, a relationship with increased disease activity was seen and needs to be confirmed for significance in a larger study. Treatment trials are also warranted. Supported by: Advisory Board of the MS Research Center of New York.
Category - MS and Related Diseases
SubCategory - Clinical Science

Wednesday, April 5, 2006 3:00 PM