A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis

University of California, Los Angeles (UCLA)

Status and phase: Withdrawn; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: testosterone; Drug: placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02317263

U01NS089369

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised McDonald Criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Testosterone gel

Active Comparator group

Description:

Apply gel once a day for 96 weeks

Treatment:

Drug: testosterone

Placebo gel

Placebo Comparator group

Description:

Apply gel once a day for 96 weeks

Treatment:

Drug: placebo gel