Heavy MEnstrual bleeding in premenopausal women treated with DirEct oral Anticoagulants - the MEDEA study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20525

Enrollment

120

Registered

2019-05-13

Start date

2020-02-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy menstrual bleeding associated with direct oral anticoagulants/factor Xa inhibitors.

Interventions

Eligible patients will be randomised in a 1:1:1 ratio to switch to dabigatran, to continue treatment with the factor Xa inhibitor without intervention, or to continue treatment with the factor Xa inhi

Eligibility

Inclusion criteria

Inclusion criteria: - 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)

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
The difference in PBAC-score before and after randomisation.	—

Secondary

Measure	Time frame
• Quality of life assessment, by means of the disease-specific menstrual bleeding questionnaire (MBQ) and a standardized 36-item short form survey (SF-36) for Quality-of-Life assessment • Laboratory values, including haemoglobin and iron-status at baseline and end of study • Any bleeding event other than heavy menstrual bleeding • Any event requiring a change in anticoagulant treatment, i.e. a newly onset thromboembolic event while on anticoagulant treatment, interruption of anticoagulant treatment before minor or major surgical procedures	—

Measure

Time frame

• Quality of life assessment, by means of the disease-specific menstrual bleeding questionnaire (MBQ) and a standardized 36-item short form survey (SF-36) for Quality-of-Life assessment • Laboratory values, including haemoglobin and iron-status at baseline and end of study • Any bleeding event other than heavy menstrual bleeding • Any event requiring a change in anticoagulant treatment, i.e. a newly onset thromboembolic event while on anticoagulant treatment, interruption of anticoagulant treatment before minor or major surgical procedures

—

Contacts

Public ContactHanke Wiegers

Amsterdam University Medical Centers - location AMC

h.m.wiegers@amsterdamumc.nl+31 20 5667516

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)