Testosterone for Fatigue in Men With MS

Summary

Fatigue is a major symptom in people with multiple sclerosis (MS), for which treatments are limited. Several studies have shown that a large proportion of men with MS have low testosterone levels. We propose a two-site clinical trial using topical testosterone gel as a treatment for MS-related fatigue in men with progressive MS who have low or low-normal testosterone levels.

Timeline

Start

2018-07-01

Primary completion

2023-06-30

Completion

2024-01-01

Publications

• Background Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, Shattuck DW, Hull L, Wang HJ, Elashoff RM, Swerdloff RS, Voskuhl RR. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007 May;64(5):683-8. doi: 10.1001/archneur.64.5.683.
• Background Kurth F, Luders E, Sicotte NL, Gaser C, Giesser BS, Swerdloff RS, Montag MJ, Voskuhl RR, Mackenzie-Graham A. Neuroprotective effects of testosterone treatment in men with multiple sclerosis. Neuroimage Clin. 2014 Mar 6;4:454-60. doi: 10.1016/j.nicl.2014.03.001. eCollection 2014.
• Background Gold SM, Chalifoux S, Giesser BS, Voskuhl RR. Immune modulation and increased neurotrophic factor production in multiple sclerosis patients treated with testosterone. J Neuroinflammation. 2008 Jul 31;5:32. doi: 10.1186/1742-2094-5-32.
• Background Ziehn MO, Avedisian AA, Dervin SM, Umeda EA, O'Dell TJ, Voskuhl RR. Therapeutic testosterone administration preserves excitatory synaptic transmission in the hippocampus during autoimmune demyelinating disease. J Neurosci. 2012 Sep 5;32(36):12312-24. doi: 10.1523/JNEUROSCI.2796-12.2012.
• Background Gold SM, Voskuhl RR. Estrogen and testosterone therapies in multiple sclerosis. Prog Brain Res. 2009;175:239-51. doi: 10.1016/S0079-6123(09)17516-7.
• Background Liva SM, Voskuhl RR. Testosterone acts directly on CD4+ T lymphocytes to increase IL-10 production. J Immunol. 2001 Aug 15;167(4):2060-7. doi: 10.4049/jimmunol.167.4.2060.
• Background Dalal M, Kim S, Voskuhl RR. Testosterone therapy ameliorates experimental autoimmune encephalomyelitis and induces a T helper 2 bias in the autoantigen-specific T lymphocyte response. J Immunol. 1997 Jul 1;159(1):3-6.
• Background Golden LC, Voskuhl R. The importance of studying sex differences in disease: The example of multiple sclerosis. J Neurosci Res. 2017 Jan 2;95(1-2):633-643. doi: 10.1002/jnr.23955.
• Background Spence RD, Voskuhl RR. Neuroprotective effects of estrogens and androgens in CNS inflammation and neurodegeneration. Front Neuroendocrinol. 2012 Jan;33(1):105-15. doi: 10.1016/j.yfrne.2011.12.001. Epub 2011 Dec 24.
• Background Hussain R, Ghoumari AM, Bielecki B, Steibel J, Boehm N, Liere P, Macklin WB, Kumar N, Habert R, Mhaouty-Kodja S, Tronche F, Sitruk-Ware R, Schumacher M, Ghandour MS. The neural androgen receptor: a therapeutic target for myelin repair in chronic demyelination. Brain. 2013 Jan;136(Pt 1):132-46. doi: 10.1093/brain/aws284.
• Background Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012 Mar 27;8(5):255-63. doi: 10.1038/nrneurol.2012.43.

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