Bulletins

Bulletins Archive

Summary: Researchers from the University of California, Los Angeles report that administering Androgel® (testosterone gel applied to the skin) to 10 men with relapsing-remitting multiple sclerosis resulted in significant improvements in cognitive function, and in slowing brain tissue loss.

• After 12 months of testosterone treatment, measures of clinical disease activity remained stable, and the men showed significant improvements in cognitive function; increases in a protein that promotes nerve cell survival; and decreases in the rate of brain tissue loss. No adverse events related to treatment were reported.
• This study was funded by the National Multiple Sclerosis Society’s initiative on Gender Differences in MS.
• Further study involving larger numbers of patients and control groups is necessary to confirm these early results.

Details: Researchers from the University of California, Los Angeles report that administering Androgel® (testosterone gel applied to the skin) to 10 men with relapsing-remitting multiple sclerosis resulted in significant improvements in cognitive function, and in slowing brain tissue loss. Relapsing-remitting MS is the most common form of the disease, involving clearly defined flare-ups followed by partial or complete recovery periods. This small study, funded by the National Multiple Sclerosis Society’s initiative on Gender Differences in MS, was reported by Nancy Sicotte, MD, Rhonda Voskuhl, MD, and colleagues at the 58^th Annual Meeting of the American Academy of Neurology in San Diego on April 7, 2007. Further study involving larger numbers of patients and control groups is necessary to confirm these early results.

Background: The National MS Society launched the initiative on Gender Differences in MS in 1998 to increase research focus on the question of why more women than men have MS, why it seems to affect women differently than men, and what the biological differences between the sexes can tell us about the cause and course of MS.

Sex hormones may contribute to MS susceptibility by influencing the immune attack on brain and spinal cord tissues. Studies have shown that the severity of EAE, an MS-like disease, is decreased when testosterone, a male sex hormone, is administered to male and female mice. Dr. Voskuhl was awarded funding from the Society’s Gender initiative to undertake a small study of testosterone gel in men with MS.

The Study: Ten men with relapsing-remitting MS were enrolled. After a six-month observation period, they were treated with testosterone gel (100 mg daily, applied to the skin) for six months. None of the men had taken disease-modifying therapies for at least six months. Clinical assessments including blood tests, as well as clinical measures of disease activity and cognitive function were completed every three months. Magnetic resonance imaging scans were taken monthly to measure evidence of disease activity.  The extent of brain tissue loss (atrophy) was assessed by determining normalized brain volumes using automated computer software (SIENA).

The Results: Since all 10 of the men received treatment and none received inactive placebo, the investigators compared measures taken before treatment versus after treatment. Testosterone levels were in the lower range of normal before treatment, and although they increased with treatment, remained in the normal range. After 12 months of testosterone treatment, measures of clinical disease activity remained stable. The men showed significant improvements in performance on a test of cognitive function called the Paced Auditory Serial Addition Task (a test of processing speed and memory) compared to the pre-treatment period. Blood tests indicated that production of brain-derived neurotrophic factor, a protein that promotes nerve cell survival, increased more than twofold after testosterone treatment. MRI scans showed no increases in tissue activity or damage during treatment. Significantly, the rates of brain atrophy, measured by normalized brain volume, slowed by 67 percent during the last nine months of treatment. No adverse events related to treatment were reported.

Conclusion: This small study shows that testosterone treatment may have therapeutic benefit in men with relapsing-remitting MS. It also demonstrates how targeting gender research has enabled scientists to develop possible therapeutic strategies for MS from exciting laboratory findings. Further study involving larger numbers of patients and control groups is necessary to confirm these early results, and to ensure the safety and effectiveness of testosterone treatment for MS.

-- Research & Clinical Programs