NL-OMON20525尚未招募不适用
Heavy menstrual bleeding in premenopausal women treated with direct oral anticoagulants - the MEDEA Study
Amsterdam University Medical Centers - location AMC0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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)
排除标准
- •-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
研究者
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