Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

This study has been terminated.
(Poor recruitment)
Sponsor:
Collaborators:
University of Manitoba
Consortium of Multiple Sclerosis Centers
Manitoba Medical Service Foundation
Information provided by (Responsible Party):
James Marriott MD, Health Sciences Centre, Winnipeg, Manitoba
ClinicalTrials.gov Identifier:
NCT01516554
First received: January 19, 2012
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

Fatigue is one of the most frequent symptoms reported by multiple sclerosis (MS) patients and is often a significant source of disability. Unlike normal fatigue, multiple sclerosis related fatigue (MSRF) occurs independently of activity level, suggesting that it is due to dysfunction in the neural pathways that regulate the perception of energy although the precise cause is still not understood. While MSRF can be managed through lifestyle modifications and with drug treatment, these measures are commonly either ineffective or only partially effective.

Administration of the male sex hormone testosterone has been shown to improve energy levels in males with testosterone-deficiency states. Testosterone also reduces fatigue in patients with other medical conditions not associated with low testosterone levels, suggesting that this treatment may also be useful in symptomatic control of MSRF.

This proposed seven-month long clinical trial is designed to test the hypothesis that administration of oral testosterone tablets to male MS patients will result in an improvement of fatigue relative to the administration of placebo tablets. As fatigue is frequently reported by MS patients to be one of their most frustrating and disabling symptoms, any proven additional treatment option for MSRF would be beneficial in improving quality of life.


Condition Intervention Phase
Multiple Sclerosis
Fatigue
Drug: Testosterone undecanoate
Drug: placebo
Phase 2

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
Official Title: A Randomized, Controlled Crossover Trial Evaluating Oral Testosterone in the Treatment of Fatigue in Male Multiple Sclerosis Patients

Resource links provided by NLM:


Further study details as provided by Health Sciences Centre, Winnipeg, Manitoba:

Primary Outcome Measures:
  • Change in fatigue (measured with Modified Fatigue Impact Scale [M-FIS]) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fatigue as measured on a visual analog scale (VAS) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Quality of life as measured with the Aging Males' Symptoms (AMS) scale [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Neurological status as measured with the Expanded Disability Status Scale (EDSS) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with , type and severity of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: February 2012
Study Completion Date: July 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone undecanoate Drug: Testosterone undecanoate
40 mg twice daily
Other Name: Andriol
Placebo Comparator: Sugar pill Drug: placebo
twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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-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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516554

Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Sponsors and Collaborators
Health Sciences Centre, Winnipeg, Manitoba
University of Manitoba
Consortium of Multiple Sclerosis Centers
Manitoba Medical Service Foundation
Investigators
Principal Investigator: James J Marriott, MD University of Manitoba
  More Information

No publications provided

Responsible Party: James Marriott MD, Assistant Professor, Health Sciences Centre, Winnipeg, Manitoba
ClinicalTrials.gov Identifier: NCT01516554     History of Changes
Other Study ID Numbers: 38486, 812.14
Study First Received: January 19, 2012
Last Updated: July 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by Health Sciences Centre, Winnipeg, Manitoba:
Multiple Sclerosis
Fatigue

Additional relevant MeSH terms:
Fatigue
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014