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Testosterone for Fatigue in Men With MS

Primary Purpose

Multiple Sclerosis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AndroGel 1 % Topical Gel

Placebos

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring testosterone, multiple sclerosis, fatigue

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept 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).

Sites / Locations

University of California, Los Angeles
Washington University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm crossover

Arm 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

Outcomes

Primary Outcome Measures

Modified Fatigue Impact Scale (MFIS)

assessment of fatigue severity

Secondary Outcome Measures

Localized Gray Matter Atrophy

Quantify effect of testosterone treatment on localized gray matter atrophy

Axon Density in White Matter

Quantify effect of testosterone treatment on axon density in major white matter tracts

Full Information

NCT ID

NCT03000127

First Posted

December 17, 2016

Last Updated

November 4, 2019

Sponsor

University of California, Los Angeles

Collaborators

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03000127

Brief Title

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

July 1, 2018 (Anticipated)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

testosterone, multiple sclerosis, fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Masking Description

All patients will receive either testosterone or placebo at some phase of treatment, but which phase will be testosterone and which will be placebo will be unknown (blinded) to participant, care provider, and outcomes assessor.

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm crossover

Arm Type

Experimental

Arm 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

Intervention Type

Drug

Intervention Name(s)

AndroGel 1 % Topical Gel

Intervention Description

testosterone gel

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Placebo gel

Primary Outcome Measure Information:

Title

Modified Fatigue Impact Scale (MFIS)

Description

assessment of fatigue severity

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Localized Gray Matter Atrophy

Description

Quantify effect of testosterone treatment on localized gray matter atrophy

Time Frame

18 months

Title

Axon Density in White Matter

Description

Quantify effect of testosterone treatment on axon density in major white matter tracts

Time Frame

18 months

Other Pre-specified Outcome Measures:

Title

Correlation of testosterone level with fatigue

Time Frame

18 months

Title

Correlation of localized gray matter atrophy with fatigue

Time Frame

18 months

Title

Correlation of axon density in white matter with fatigue

Time Frame

18 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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).

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Washington University

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17502467

Citation

Sicotte NL, Giesser BS, Tandon V, Klutch R, Steiner B, Drain AE, Shattuck DW, Hull L, Wang HJ, Elashoff RM, Swerdloff RS, Voskuhl RR. Testosterone treatment in multiple sclerosis: a pilot study. Arch Neurol. 2007 May;64(5):683-8. doi: 10.1001/archneur.64.5.683.

Results Reference

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PubMed Identifier

24634831

Citation

Kurth F, Luders E, Sicotte NL, Gaser C, Giesser BS, Swerdloff RS, Montag MJ, Voskuhl RR, Mackenzie-Graham A. Neuroprotective effects of testosterone treatment in men with multiple sclerosis. Neuroimage Clin. 2014 Mar 6;4:454-60. doi: 10.1016/j.nicl.2014.03.001. eCollection 2014.

Results Reference

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PubMed Identifier

18671877

Citation

Gold SM, Chalifoux S, Giesser BS, Voskuhl RR. Immune modulation and increased neurotrophic factor production in multiple sclerosis patients treated with testosterone. J Neuroinflammation. 2008 Jul 31;5:32. doi: 10.1186/1742-2094-5-32.

Results Reference

background

PubMed Identifier

22956822

Citation

Ziehn MO, Avedisian AA, Dervin SM, Umeda EA, O'Dell TJ, Voskuhl RR. Therapeutic testosterone administration preserves excitatory synaptic transmission in the hippocampus during autoimmune demyelinating disease. J Neurosci. 2012 Sep 5;32(36):12312-24. doi: 10.1523/JNEUROSCI.2796-12.2012.

Results Reference

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PubMed Identifier

19660660

Citation

Gold SM, Voskuhl RR. Estrogen and testosterone therapies in multiple sclerosis. Prog Brain Res. 2009;175:239-51. doi: 10.1016/S0079-6123(09)17516-7.

Results Reference

background

PubMed Identifier

11489988

Citation

Liva SM, Voskuhl RR. Testosterone acts directly on CD4+ T lymphocytes to increase IL-10 production. J Immunol. 2001 Aug 15;167(4):2060-7. doi: 10.4049/jimmunol.167.4.2060.

Results Reference

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PubMed Identifier

9200430

Citation

Dalal M, Kim S, Voskuhl RR. Testosterone therapy ameliorates experimental autoimmune encephalomyelitis and induces a T helper 2 bias in the autoantigen-specific T lymphocyte response. J Immunol. 1997 Jul 1;159(1):3-6.

Results Reference

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PubMed Identifier

27870415

Citation

Golden LC, Voskuhl R. The importance of studying sex differences in disease: The example of multiple sclerosis. J Neurosci Res. 2017 Jan 2;95(1-2):633-643. doi: 10.1002/jnr.23955.

Results Reference

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PubMed Identifier

22209870

Citation

Spence RD, Voskuhl RR. Neuroprotective effects of estrogens and androgens in CNS inflammation and neurodegeneration. Front Neuroendocrinol. 2012 Jan;33(1):105-15. doi: 10.1016/j.yfrne.2011.12.001. Epub 2011 Dec 24.

Results Reference

background

PubMed Identifier

23365095

Citation

Hussain R, Ghoumari AM, Bielecki B, Steibel J, Boehm N, Liere P, Macklin WB, Kumar N, Habert R, Mhaouty-Kodja S, Tronche F, Sitruk-Ware R, Schumacher M, Ghandour MS. The neural androgen receptor: a therapeutic target for myelin repair in chronic demyelination. Brain. 2013 Jan;136(Pt 1):132-46. doi: 10.1093/brain/aws284.

Results Reference

background

PubMed Identifier

22450508

Citation

Voskuhl RR, Gold SM. Sex-related factors in multiple sclerosis susceptibility and progression. Nat Rev Neurol. 2012 Mar 27;8(5):255-63. doi: 10.1038/nrneurol.2012.43.

Results Reference

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Testosterone for Fatigue in Men With MS

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