Clinical trial NCT03000127: Testosterone for Fatigue in Men With MS
Official title: A Pilot Trial of Testosterone Treatment for Fatigue in Men With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: testosterone
multiple sclerosis
fatigue
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2016-12-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, testosterone or placebo will be administered to all patients at some period of study, but which period of study the they will recieve placebo or testosterone gel will be blinded (unknown) to participant, care provider, and outcomes assessor.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 18 months
Secondary outcomes:
measure: Localized Gray Matter Atrophy
timeFrame: 18 months
measure: Axon Density in White Matter
timeFrame: 18 months
Other outcomes:
measure: Correlation of testosterone level with fatigue
timeFrame: 18 months
measure: Correlation of localized gray matter atrophy with fatigue
timeFrame: 18 months
measure: Correlation of axon density in white matter with fatigue
timeFrame: 18 months
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
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