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临床试验/EUCTR2005-001016-51-SE
EUCTR2005-001016-51-SE
进行中(未招募)
不适用

In vivo effects of transdermal Estradiol+ oral Progesterone vs oral Conjugated Equine Estrogens + MedroxyProgesteroneAcetate on normal human breast cells proliferation: a randomized comparative study

Karolinska Hospital0 个研究点目标入组 80 人2005年8月4日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Menopausal symptoms
发起方
Karolinska Hospital
入组人数
80
状态
进行中(未招募)
最后更新
14年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2005年8月4日
结束日期
待定
最后更新
14年前
研究类型
Interventional clinical trial of medicinal product
性别
Female

研究者

发起方
Karolinska Hospital

入排标准

入选标准

  • 80 healthy, non\-smoking postmenopausal women, between 40 and 65 years of age, without known breast pathology.
  • Normal screening mammogram.
  • 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

  • \-known malignant breast pathology
  • \-multiple scars on breasts after breast surgery
  • \-current treatment of following medications:
  • any hormonal replacement therapy; three months wash out period for past users
  • any long term treatment containing progestin or estrogen
  • any drugs known to inhibit hepatic drug metabolism ( i.e. barbiturates, carbamazepines, phenytoin, glucocorticoids, rifampin, antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, verapamil, quinidine )
  • \-participation in an investigational study within 30 days prior to the study medication
  • \-any clinically significant abnormality found during medical screening
  • \-any clinically significant abnormal laboratory test
  • \-BMI \< 18,1 or \>29,9

结局指标

主要结局

未指定

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