Testosterone for Fatigue in Men With MS
Testosterone for Fatigue in Men With MS
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.
Inclusion Criteria:

 1) Men with SPMS or PPMS, 2)18-60 years old, 3) EDSS of 1.0- 6.5, 4) Low or low-normal T <
 499ng/dL and 5) FSS scores of >3.6.

 Exclusion Criteria:

 1) Prostate specific antigen > 2.5 (<49yr of age) or >3.5 (age >50yr of age), 2) baseline
 hematocrit greater than the upper limit of normal for the laboratory used, 3) EKG with
 ischemic changes, 4) history of myocardial infarction, unstable angina, stroke, transient
 ischemic attack, or deep vein thrombosis, 5) history of prostate or breast cancer, 6)
 screening T level >500ng/dL, 7) diabetes requiring treatment, 8) current drug/alcohol
 abuse, 9) disease other than MS causing fatigue, such as obstructive sleep apnea or other
 sleep disorder, or untreated thyroid dysfunction, 10) RRMS, 11) Beck Depression
 Inventory-II (BDI) score over 20, 12) cognitive dysfunction such that subject cannot
 perform study tests, 13) inability to undergo MRI, 14) current or expected use of
 amphetamines, or 15) anticipated changes in medical treatments that might affect fatigue
 scores (e.g., expected changes in spasticity, sleep, or depression medications).