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

Phase 2

Withdrawn

• Conditions: Multiple Sclerosis
• Interventions: Drug: placebo gel; Drug: testosterone

• Registration Number: NCT02317263
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-04
• Primary Completion: 2099-01
• Study Completion: 2099-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo gel	placebo gel	Apply gel once a day for 96 weeks
Testosterone gel	testosterone	Apply gel once a day for 96 weeks

Primary Outcome Measures

Name	Time	Method
Whole Brain Atrophy	96 weeks