Testosterone for Fatigue in Men With MS

Phase 2

Withdrawn

• Conditions: Multiple Sclerosis
• Interventions: Drug: AndroGel 1 % Topical Gel; Drug: Placebos

• Registration Number: NCT03000127
• Lead Sponsor: University of California, Los Angeles

Brief Summary

Fatigue is a major symptom in people with multiple sclerosis (MS), for which treatments are limited. Several studies have shown that a large proportion of men with MS have low testosterone levels. We propose a two-site clinical trial using topical testosterone gel as a treatment for MS-related fatigue in men with progressive MS who have low or low-normal testosterone levels.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-17
• Study First Submitted QC: 2016-12-17
• Study First Posted: 2016-12-21
• Study Start: 2018-07-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-06
• Primary Completion: 2023-06-30
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Men with SPMS or PPMS, 2)18-60 years old, 3) EDSS of 1.0- 6.5, 4) Low or low-normal T < 499ng/dL and 5) FSS scores of >3.6.

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Exclusion Criteria

1. Prostate specific antigen > 2.5 (<49yr of age) or >3.5 (age >50yr of age), 2) baseline hematocrit greater than the upper limit of normal for the laboratory used, 3) EKG with ischemic changes, 4) history of myocardial infarction, unstable angina, stroke, transient ischemic attack, or deep vein thrombosis, 5) history of prostate or breast cancer, 6) screening T level >500ng/dL, 7) diabetes requiring treatment, 8) current drug/alcohol abuse, 9) disease other than MS causing fatigue, such as obstructive sleep apnea or other sleep disorder, or untreated thyroid dysfunction, 10) RRMS, 11) Beck Depression Inventory-II (BDI) score over 20, 12) cognitive dysfunction such that subject cannot perform study tests, 13) inability to undergo MRI, 14) current or expected use of amphetamines, or 15) anticipated changes in medical treatments that might affect fatigue scores (e.g., expected changes in spasticity, sleep, or depression medications).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm crossover	AndroGel 1 % Topical Gel	All patients will receive testosterone gel and placebo gel during some months, but the months that they are on each treatment will be unknown to the patient
Single arm crossover	Placebos	All patients will receive testosterone gel and placebo gel during some months, but the months that they are on each treatment will be unknown to the patient

Primary Outcome Measures

Name	Time	Method
Modified Fatigue Impact Scale (MFIS)	18 months	assessment of fatigue severity

Secondary Outcome Measures

Name	Time	Method
Localized Gray Matter Atrophy	18 months	Quantify effect of testosterone treatment on localized gray matter atrophy
Axon Density in White Matter	18 months	Quantify effect of testosterone treatment on axon density in major white matter tracts

Trial Locations

Locations (2)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States