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

INTERVENTION: Trade Name: Pradaxa / Dabigatran etexilate Product Name: Pradaxa Product Code: EU/1/08/442 Pharmaceutical Form: Capsule, hard Trade Name: Cyklokapron / Tranexamic acid Product Name: Cyklokapron Product Code: RVG 05574 Pharmaceutical Form: Film‐coated tablet CONDITION: Heavy menstrual bleeding associated with direct oral anticoagulants in premenopausal women. ; MedDRA version: 20.0 Level: PT Classification code 10027313 Term: Menorrhagia System Organ Class: 10038604 ‐ Reproductive system and breast disorders ; MedDRA version: 20.0 Level: PT Classification code 10053468 Term: Anticoagulant therapy System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy. Primary end point(s): ; 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 Objective: Not applicable. Timepoint(s) of evaluation of this end point: Three menstrual cycles after randomisation. SECONDARY OUTCOME: Secondary end point(s): ‐ 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 Timepoint(s) of evaluation of this end point: Three menstrual cycles after randomisation. 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) 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