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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05528666` - Risk Perception in Multiple Sclerosis
Completed	`NCT03608527` - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis	N/A
Recruiting	`NCT05532943` - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis	Phase 1/Phase 2
Completed	`NCT02486640` - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed	`NCT01324232` - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis	Phase 2
Completed	`NCT04546698` - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting	`NCT04380220` - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed	`NCT02835677` - Integrating Caregiver Support Into MS Care	N/A
Completed	`NCT03686826` - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting	`NCT05964829` - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis	N/A
Withdrawn	`NCT06021561` - Orofacial Pain in Multiple Sclerosis
Completed	`NCT03653585` - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting	`NCT04798651` - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis	N/A
Active, not recruiting	`NCT05054140` - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis	Phase 2
Completed	`NCT05447143` - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis	N/A
Recruiting	`NCT06195644` - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients	Phase 1
Completed	`NCT04147052` - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis	N/A
Completed	`NCT03591809` - Combined Exercise Training in Patients With Multiple Sclerosis	N/A
Completed	`NCT03594357` - Cognitive Functions in Patients With Multiple Sclerosis
Completed	`NCT02845635` - MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis