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。
研究者
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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