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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn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• Status: Withdrawn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

• Multiple Sclerosis
• Sclerosis

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