NCT02317263

Brief Summary

This is a multicenter, prospective, placebo-controlled, double-blind randomized Phase II clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96 weeks duration on whole brain atrophy in men with MS.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
84.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2099

Last Updated

August 4, 2016

Status Verified

August 1, 2016

First QC Date

December 3, 2014

Last Update Submit

August 2, 2016

Conditions

Multiple Sclerosis

Keywords

MS

Outcome Measures

Primary Outcomes (1)

  • Whole Brain Atrophy

    96 weeks

Study Arms (2)

Testosterone gel

ACTIVE COMPARATOR

Apply gel once a day for 96 weeks

Drug: testosterone

Placebo gel

PLACEBO COMPARATOR

Apply gel once a day for 96 weeks

Drug: placebo gel

Interventions

testosteroneDRUG
Testosterone gel
placebo gelDRUG
Placebo gel

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 15, 2014

Primary Completion (Estimated)

January 1, 2099

Study Completion (Estimated)

January 1, 2099

Last Updated

August 4, 2016

Record last verified: 2016-08