临床试验/NCT02317263

NCT02317263撤回2 期

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

University of California, Los Angeles0 个研究点开始时间: 2014年12月15日最近更新: 2016年8月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方: University of California, Los Angeles
主要终点: Whole Brain Atrophy

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: Male
接受健康志愿者: 否

入选标准

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

排除标准

未提供

研究组 & 干预措施

Testosterone gel

Active Comparator

Apply gel once a day for 96 weeks

干预措施: testosterone (Drug)

Placebo gel

Placebo Comparator

Apply gel once a day for 96 weeks

干预措施: placebo gel (Drug)

结局指标

主要结局

Whole Brain Atrophy

时间窗: 96 weeks

次要结局

未报告次要终点

研究者

发起方

University of California, Los Angeles

申办方类型

Other

责任方

Sponsor

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