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Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

NCT01516554 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2014-07-08

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Testosterone undecanoate

40 mg twice daily

DRUG

placebo

twice daily

Sponsors & Collaborators

  • University of Manitoba

    collaborator OTHER

  • Consortium of Multiple Sclerosis Centers

    collaborator OTHER

  • Manitoba Medical Service Foundation

    collaborator OTHER

  • Health Sciences Centre, Winnipeg, Manitoba

    lead OTHER

Principal Investigators

  • James J Marriott, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-01-31
Completion
2014-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01516554 on ClinicalTrials.gov