跳至主要内容
临床试验/EUCTR2006-005460-30-IT
EUCTR2006-005460-30-IT进行中(未招募)不适用

POPART?MUS Prevention of Post Partum Relapses with Progestin and Estradiolin Multiple sclerosis - POPART`MUS

OSPEDALI CIVILI DI LIONE0 个研究点目标入组 300 人开始时间: 2008年10月27日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • - Multiple sclerosis according to Mac Donald criteria (including clinically syndromes fulfilling MRI
  • criteria for MS diagnosis)
  • - Relapses-remitting or Secondary Progressive MS
  • - EDSS ≤ 6.0
  • - Pregnancy ≤ 36 weeks of amenorrhea
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Age < 18 years
  • - Clinical Isolated Syndrome not fulfilling MacDonald?s criteria
  • - Primary progressive MS
  • - Possible MS or no MS according to Mc Donald?s criteria
  • - On going or previous myocardial infection, stroke or venous thrombo-embolism
  • - On going or previous breast cancer, or cancer of the uterus
  • - Severe liver disorder
  • - Undiagnosed genital bleeding
  • - Hypersensitivity to one of the study treatment
  • - Desire for lactation
  • - Desire for a MS disease-modifying treatment in the 24 weeks after delivery
  • - Woman participating to another trial with a drug
  • - Refusal of non-hormonal contraception in the 12 weeks following delivery
  • - Consent form not signed

研究者

发起方
OSPEDALI CIVILI DI LIONE

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