Safety of oral micronized progesterone versus norethisterone acetate in continuous combination with oral estrogen as menopausal hormone therapy – a double-blind randomized study- PROBES study (Progesterone Breast Endometrial Safety study)

Karolinska University Hospital0 个研究点目标入组 520 人2021年6月14日

概览

暂无简介。

注册库

who.int

开始日期

2021年6月14日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

发起方

Karolinska University Hospital

•\- Healthy and naturally postmenopausal women (more than one year since last menstruation or FSH \> 40 IE/L)
•with climacteric symptoms (sweating, hot flush and sleep problems) that adversely affect quality of life.
•\- Age 45\-60 years
•\- BMI \> 19 kg/m2 and \= 32 kg/m2
•\- Intact uterus
•\- In case of previous MHT use, washout 8 weeks for oral MHT and 4 weeks for transdermal MHT or local
•estrogen treatment before screening
•\- Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\- Previous history of breast cancer or abnormal mammogram at baseline as assessed clinically by a radiology
•\- Previous history of endometrial cancer or hyperplasia or abnormal/proliferative endometrial biopsy at
•\- Vaginal bleeding
•\- Any concomitant medical treatment except for well\-controlled hypertension, non\-insulin treated type 2
•diabetes, asthma and hypothyroidism
•\- History or presence of cardiovascular disease including thromboembolic disorder or cerebrovascular disease
•\- History or presence of liver disease, familial hyperlipidemia, epilepsy or classical migraine with aura
•\- History or presence of clinically significant depression or other psychiatric disorder that might in anyway
•compromise the performance of the trial or undermine its scientific validity
•\- Current use of MHT or local estrogen treatment