Heavy menstrual bleeding in premenopausal women treated with direct oral anticoagulants - the MEDEA study - MEDEA

Amsterdam University Medical Centers - location AMC0 个研究点目标入组 120 人开始时间: 2019年11月12日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•- premenopausal women
•- age =18 years
•- anticoagulant treatment with a factor Xa inhibitor
•- indication for anticoagulant treatment >3months after inclusion
•- heavy menstrual bleeding and a PBAC-score >150
•- use of adequate contraceptive methods during study participation (this is advised to any woman on factor Xa inhibitors during fertile ages, regardless of study participation)
•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 120
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- PBAC-score =150
•- postmenopausal women; women >12 consecutive months of spontaneous amenorrhea
•- concomitant use of hormonal therapy as a new intervention for HMB
•- pregnancy or currently planning for pregnancy
•- active malignancy or treatment with chemotherapy/radiotherapy
•- cervical preneoplastic lesions
•- contra indication for the registered products dabigatran or tranexamic acid
•- any condition that, as judged by investigator, would place the subject at an increased risk of harm if she participated in the study

发起方

Amsterdam University Medical Centers - location AMC