Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients
Status:
Terminated
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Health Sciences Centre, Winnipeg, Manitoba
Collaborators:
Consortium of Multiple Sclerosis Centers Manitoba Medical Service Foundation University of Manitoba