NCT00405353

Brief Summary

Since men are less likely to develop multiple sclerosis, the hypothesis was that testosterone might be protective in MS. Men with MS for followed untreated for 6 months, followed by a 12 month treatment period with Androgel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 multiple-sclerosis

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
12.7 years until next milestone

Results Posted

Study results publicly available

November 22, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

4.9 years

First QC Date

November 28, 2006

Results QC Date

January 23, 2015

Last Update Submit

November 4, 2019

Conditions

Multiple Sclerosis

Keywords

multiple sclerosistestosterone

Outcome Measures

Primary Outcomes (1)

  • Whole Brain Atrophy Rate

    as assessed by Voxel-Based Morphometry

    Baseline and 12 months

Study Arms (1)

crossover treatment with Androgel

EXPERIMENTAL

6 months pretreatment, 12 months treatment intervention with Androgel 10 grams of gel containing 100mg of testosterone

Drug: Androgel 10 grams of gel containing 100 mg of testosterone

Interventions

Androgel 10 grams of gel containing 100 mg of testosteroneDRUG

testosterone gel

Also known as: testosterone
crossover treatment with Androgel

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men, age 18-65, with a diagnosis of clinically definite relapsing remitting multiple sclerosis.
  • Relapsing remitting patients who have declined or not tolerated treatment with beta interferon (Betaseron, Avonex) or glatiramer acetate, copolymer-1 (Copaxone).
  • At least one relapse in the two years prior to entry. Relapse will be defined historically as definite worsening of a previous symptom (over 0-3 days) or development of a new symptom (over 0-3 days).
  • Not in an intercurrent relapse.
  • Expanded Disability Status Score (EDSS) = 0.0 to 5.0.
  • The patients must have a significant T2 burden of disease on screening cerebral MRI as defined by T2 lesion loads greater than 7.5cm3.
  • Must live within 100 miles of UCLA.
  • Must be willing and able to receive an initial screening cerebral MRI, a baseline MRI and monthly cerebral MRIs (with and without gadolinium) for a total period of 12 months (6 months prior to treatment and 6 months during treatment).

You may not qualify if:

  • Males unable to fulfill the above criteria and all female patients.
  • Males who have been on sex hormone treatment including androgens, estrogens, or anti-estrogens for hypogonadism or other medical condition during the 12 months prior to study.
  • Males who have taken DHEA during the 3 months prior to study.
  • Patients who have thrombosis, serious cardiac, pulmonary, renal, gastrointestinal, hepatic, immunologic, infectious, neoplastic (with particular focus on patients with known or suspected estrogen or testosterone-dependent tumors), or urologic disease (with a particular focus on patients with a history of prostatic hypertrophy/nodules).
  • Patients with an abnormal prostate as evidenced by prostatic masses or induration on rectal examination or prostate ultrasonography or elevated levels of prostatic specific antigen (PSA 4 ng/ml or higher).
  • Patients with testicular mass on exam.
  • Patients with hematocrit greater than 50%
  • Patients with major psychiatric illness (e.g. manic depressive states, schizophrenia)
  • Patients with active alcoholism.
  • Patients with a history of drug abuse within the past five years.
  • Patients who are greater than 130% or less than 80% of their ideal body weight based on Metropolitan Life Tables.
  • Patients with generalized skin disease that may effect absorption of testosterone (e.g. psoriasis) or a known skin intolerance to alcohol.
  • Patients with prolactin \> 40 mcg/L.
  • Patients with a cholesterol level greater than 300 mg/dl.
  • Patients with other conditions that would interfere with assessing neurologic functions such as deforming arthritis or a major amputation.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (4)

  • 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.

    PMID: 22956822BACKGROUND

  • 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.

    PMID: 17502467RESULT

  • 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.

    PMID: 18671877RESULT

  • 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.

    PMID: 24634831RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. Rhonda Voskuhl
Organization
UCLA
rvoskuhl@mednet.ucla.edu
(310) 206-4636

Study Officials

  • Rhonda Voskuhl, M.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Neurology; Director Multiple Sclerosis Program

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

April 1, 2002

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

November 22, 2019

Results First Posted

November 22, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)