Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients

Status Terminated

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01516554
Study type	Interventional
Source	Health Sciences Centre, Winnipeg, Manitoba
Contact
Status	Terminated
Phase	Phase 2
Start date	February 2012
Completion date	July 2014

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