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 人开始时间: 2005年8月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•-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
•-history of allergic reactions to the IMP´s
•-history of severe liver or gallbladder disease or dysfunction, coagulation disorder
•-History of active malignancy.
•-Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
•-Subjects will be instructed to abstain from vitamins, alcohol, tobacco and natural products starting 7 days prior to study treatment until the end of the study. Precise information will be recorded in the clinical forms.

发起方

Karolinska Hospital