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NCT02317263 Clinical Trial

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

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02317263
Other study ID # U01NS089369
Secondary ID
Status Withdrawn
Phase Phase 2
First received December 3, 2014
Last updated August 2, 2016
Est. completion date January 2099

Study information
Verified date August 2016
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2099
Est. primary completion date January 2099
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: Men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised McDonald Criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• testosterone

• placebo gel

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of California, Los Angeles

Outcome
Type Measure Description Time frame Safety issue
Primary Whole Brain Atrophy 96 weeks
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