Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01516554
• Date of registration: 19/01/2012
• Prospective Registration: Yes
• Primary sponsor: Health Sciences Centre, Winnipeg, Manitoba
• Public title: Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients
• Scientific title: A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients
• Date of first enrolment: February 2012
• Target sample size: 3
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01516554
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: James J Marriott, MD
• Affiliation: University of Manitoba

Key inclusion & exclusion criteria

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-ß1a [Avonex®, Rebif®], interferon-ß1b [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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Fatigue

Multiple Sclerosis

Intervention(s)

Drug: Testosterone undecanoate

Drug: placebo

Primary Outcome(s)

Change in fatigue (measured with Modified Fatigue Impact Scale [M-FIS]) [Time Frame: baseline and 12 weeks]

Secondary Outcome(s)

Neurological status as measured with the Expanded Disability Status Scale (EDSS) [Time Frame: baseline and 12 weeks]

Change in fatigue as measured on a visual analog scale (VAS) [Time Frame: baseline and 12 weeks]

Number of participants with , type and severity of adverse events [Time Frame: 12 weeks]

Quality of life as measured with the Aging Males' Symptoms (AMS) scale [Time Frame: baseline and 12 weeks]

Secondary ID(s)

812.14

38486

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Manitoba

Consortium of Multiple Sclerosis Centers

Manitoba Medical Service Foundation