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Multiple SclerosisPhase 2NCT03000127

Testosterone for Fatigue in Men With MS

A Phase 2 study testing AndroGel 1 % Topical Gel in people with Multiple Sclerosis, run by University of California, Los Angeles at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, men only
Conditions the study is for
Multiple Sclerosis
What is being tested?
AndroGel 1 % Topical Gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesUnited States
Study dates
1 Jul 2018to 1 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Pilot Trial of Testosterone Treatment for Fatigue in Men With Multiple Sclerosis

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.

Being tested
AndroGel 1 % Topical Gel, Placebos
Keywords
testosterone, multiple sclerosis, fatigue
Medical subject headings
Multiple Sclerosis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AndroGel 1 % Topical GelDrug

    testosterone gel

  • PlacebosDrug

    Placebo gel

Study groups in NCT03000127
Study groupRoleWhat they receive
Single arm crossoverExperimentalAll 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
Receives: Drug: AndroGel 1 % Topical Gel; Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Fatigue Impact Scale (MFIS)

    assessment of fatigue severity

    Measured: 18 months

Secondary outcomes (2)

  1. Localized Gray Matter Atrophy

    Quantify effect of testosterone treatment on localized gray matter atrophy

    Measured: 18 months

  2. Axon Density in White Matter

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

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study start1 Jul 2018 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Why it stopped: Lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03000127
Sponsor's protocol ID
1R01NS102295
Status last verified
Nov 2019
First submitted
17 Dec 2016
Last updated
6 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17502467

  • 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.

    PubMed 24634831

  • 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.

    PubMed 18671877

  • 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.

    PubMed 22956822

  • 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.

    PubMed 19660660

  • 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.

    PubMed 11489988

  • 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.

    PubMed 9200430

  • 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.

    PubMed 27870415

  • 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.

    PubMed 22209870

  • 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.

    PubMed 23365095

  • 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.

    PubMed 22450508

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AndroGel 1 % Topical Gel in people with Multiple Sclerosis, run by University of California, Los Angeles at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Fatigue Impact Scale (MFIS) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03000127, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.

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Testosterone for Fatigue in Men With MS (NCT03000127) | AzTrials