Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

Inclusion Criteria:

• All adult male (18—65 years old) patients are eligible. Patients over > 65 years will be excluded due to increased risk of prostatic hypertrophy or carcinoma in that age group.
• Patients must have diagnosis of MS using the 2005 revised McDonald Criteria.
• Patients must have an EDSS score ≤ 6.5.
• Patients must have a baseline MFIS score ≥ 45 (i.e.: those patients with fatigue).
• Patients must consent to participate in the study after a discussion of the potential risks and benefits of study participation with their physician. This consent must acknowledge that testosterone administration in MS is experimental and of no proven benefit.
• Patients must not be on any other agents to specifically treat MSRF (modafinil [Alertec®], amantadine, methylphenidate [Ritalin®, Ritalin SR®, Concerta®].

Exclusion Criteria:

• Previous or current testosterone administration.
• Any Health Canada approved indication for testosterone administration.
• Known hypersensitivity any component of the testosterone undecanoate (Andriol®) formulation including soy.
• History of relapse in the past 3 months.
• History of prostate hypertrophy or prostate carcinoma.
• History of breast cancer.
• Moderate or severe prostate symptoms (International Prostate Symptom Score [IPSS] ≥ 8).
• All patients ≥ 50 years old (or ≥ 40 years old if history of prostate cancer/prostate hypertrophy in a first-degree relative or if African-Canadian) will be require a urological assessment including prostate specific antigen (PSA) and digital rectal exam (DRE). Such patients will be excluded if they have a high PSA level or if they have a palpable prostate nodule. Abnormal PSA levels will be determined using standard age-specific cut-off levels.
• Other serious medical comorbidities including: any other cancer or myelodysplastic syndrome, anemia or polycythemia of any cause, vascular risk factors (including hypertension, dyslipidemia, myocardial infarction, stroke, peripheral vascular disease, atrial fibrillation, other hypercoaguable state or thrombotic risk factor), serious kidney or liver disease, diabetes, obstructive sleep apnea or serious psychiatric disease.
• History of current alcohol misuse.
• Recent major surgery.
• Use of the following medications whose metabolism may be altered by TT: warfarin, corticosteroids, propranolol, cyclosporine or St. John's Wort.81
• Patients on cyclophosphamide or mitoxantrone (Novantrone®) chemotherapy for MS will be excluded. Patients on other approved disease-modifying therapies for MS (interferon-β1a [Avonex®, Rebif®], interferon-β1b [Betaseron®], glatiramer acetate [Copaxone®] and natalizumab [Tysabri®]) can participate in this trial provided they have been on these therapies for at least six months at a stable dose.