Testosterone for Fatigue in Men With MS

University of California, Los Angeles (UCLA)

Status and phase: Withdrawn; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: AndroGel 1 % Topical Gel; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03000127

1R01NS102295

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single arm crossover

Experimental group

Description:

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

Treatment:

Drug: Placebos

Drug: AndroGel 1 % Topical Gel