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Multiple SclerosisPhase 2NCT01516554

Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

A Phase 2 study testing Testosterone undecanoate in people with Multiple Sclerosis and Fatigue, run by Health Sciences Centre, Winnipeg, Manitoba at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Multiple Sclerosis, Fatigue
What is being tested?
Testosterone undecanoate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteCanada
Study dates
Feb 2012to Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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®].

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A1R9

Other trials in Canada

About this study

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

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.

Being tested
Testosterone undecanoate, placebo
Keywords
Multiple Sclerosis, Fatigue
Medical subject headings
Multiple Sclerosis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone undecanoateDrug

    Also called Andriol

    40 mg twice daily

  • placeboDrug

    twice daily

Study groups in NCT01516554
Study groupRoleWhat they receive
Testosterone undecanoateExperimentalNot described
Receives: Drug: Testosterone undecanoate
Sugar pillPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fatigue (measured with Modified Fatigue Impact Scale [M-FIS])

    Measured: baseline and 12 weeks

Secondary outcomes (4)

  1. Change in fatigue as measured on a visual analog scale (VAS)

    Measured: baseline and 12 weeks

  2. Quality of life as measured with the Aging Males' Symptoms (AMS) scale

    Measured: baseline and 12 weeks

  3. Neurological status as measured with the Expanded Disability Status Scale (EDSS)

    Measured: baseline and 12 weeks

  4. Number of participants with , type and severity of adverse events

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJan 2014
  4. Study completionJul 2014

Why it stopped: Poor recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516554
Sponsor's protocol ID
38486
Other IDs
812.14
Status last verified
Jul 2014
First submitted
19 Jan 2012
Last updated
8 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone undecanoate in people with Multiple Sclerosis and Fatigue, run by Health Sciences Centre, Winnipeg, Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fatigue (measured with Modified Fatigue Impact Scale [M-FIS]) (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.

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