EUCTR2021-001624-17-SE进行中（未招募）1 期
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 人开始时间: 2021年6月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 520
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
- •- 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 520
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- 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
- •- Alcohol and/or drug abuse
- •- Clinically significant findings on physical and/or gynecological examination at baseline
- •- Hypersensitivity to any of the study treatments
研究者
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