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A Pilot Study

Nancy L. Sicotte, MD; Barbara S. Giesser, MD; Vinita Tandon, MD; Ricki Klutch, RN; Barbara Steiner, RN; Ann E. Drain, BS; David W. Shattuck, PhD; Laura Hull, BS; He-Jing Wang, PhD; Robert M. Elashoff, PhD; Ronald S. Swerdloff, MD; Rhonda R. Voskuhl, MD

Arch Neurol. 2007;64(5):683-688.

Objective  To study the effect of testosterone supplementation on men with multiple sclerosis (MS).

Design, Setting, and Participants  Men are less susceptible to many autoimmune diseases, including MS. Possible causes for this include sex hormones and/or sex chromosome effects. Testosterone treatment ameliorates experimental allergic encephalomyelitis, an animal model of MS, but the effect of testosterone supplementation on men with MS is not known. Therefore, 10 men with relapsing-remitting MS were studied using a crossover design whereby each patient served as his own control. There was a 6-month pretreatment period followed by a 12-month period of daily treatment with 10 g of the gel containing 100 mg of testosterone.

Main Outcome Measures  Clinical measures of disability and cognition (the Multiple Sclerosis Functional Composite and the 7/24 Spatial Recall Test) and monthly magnetic resonance imaging measures of enhancing lesion activity and whole brain volumes.

Results  One year of treatment with testosterone gel was associated with improvement in cognitive performance (P  = .008) and a slowing of brain atrophy (P <.001). There was no significant effect of testosterone treatment on gadolinium-enhancing lesion numbers (P  = .31) or volumes (P  = .94). Lean body mass (muscle mass) was increased (P  = .02).

Conclusion  These exploratory findings suggest that testosterone treatment is safe and well tolerated and has potential neuroprotective effects in men with relapsing-remitting MS.

Trial Information  clinicaltrials.gov Identifier: NCT00405353

Author Affiliations: Division of Brain Mapping (Dr Sicotte and Ms Drain), Departments of Neurology (Drs Sicotte, Giesser, and Voskuhl, and Mss Klutch and Drain) and Biomathematics (Drs Wang and Elashoff), and Laboratory of Neuro Imaging (Dr Shattuck), The David Geffen School of Medicine at UCLA, Los Angeles, Calif; and Division of Endocrinology, Department of Medicine, Harbor-UCLA Medical Center, Torrance, Calif (Drs Tandon and Swerdloff and Mss Steiner and Hull).