heavy menstrual bleeding Menorrhagia
Conditions
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 in
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
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 pictorial bleeding assessment chart (PBAC)-score, a validated score for assessing HMB, before randomisation (i.e. while on factor Xa treatment) compared to the PBAC-score after randomisation. The primary analysis is a comparison of the mean PBAC-score before randomization (i.e. while on factor Xa treatment) with the mean PBAC-score after the participant has switched to dabigatran. | — |
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 | — |
Countries
Netherlands
Outcome results
None listed