NL-OMON55056已完成4 期
Heavy menstrual bleeding in premenopausal women treated with direct oral anticoagulants - a randomised controlled trial. - MEDEA
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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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