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临床试验/EUCTR2015-002308-10-NL
EUCTR2015-002308-10-NL进行中(未招募)不适用

A randomized, single blinded trial to evaluate the efficacy of Imiquimod in women with residual/recurrent Cervical Intraepithelial Neoplasia (CIN) after previous treatment - TOPIC-2

未提供0 个研究点开始时间: 2015年7月9日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)

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

  • - Histologically proven CIN2 or CIN 3, without invasion after previous surgical treatment at least 6 months before diagnosis
  • - Histologically proven persistent CIN 1 after previous surigcal treament at least 6 months before diagnosis. Persistent CIN 1 is defined as CIN 1 at least persistent for 6 months and proven with histology
  • - The patient is willing to use a medically acceptable method of contraception throughout the study
  • - Women older than 18 years of age
  • 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 410
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Pregnancy or lactation
  • -(Micro-)invasive carcinoma
  • -Past history of cervical cancer
  • -Hypersensitivity of any components of the formulation
  • -History of psoriasis or other inflammatory dermatosis of the vulva
  • -Immunodeficiency or treatment with immunosuppressive medication
  • -Insufficient understanding of the Dutch or English language

研究者

发起方
未提供

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