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

Phase 1

• Conditions: Heavy menstrual bleeding associated with direct oral anticoagulants in premenopausal women.; MedDRA version: 24.0Level: LLTClassification code 10027313Term: MenorrhagiaSystem Organ Class: 100000004872; MedDRA version: 20.0Level: PTClassification code 10053468Term: Anticoagulant therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2019-002138-35-NL
• Lead Sponsor: Amsterdam University Medical Centers - location AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-12
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy.;Secondary Objective: Not applicable.;Primary end point(s): <br>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.;Timepoint(s) of evaluation of this end point: Three menstrual cycles after randomisation.

Secondary Outcome Measures

Name	Time	Method
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<br>- Laboratory values, including haemoglobin and iron-status at baseline and end of study<br>- Any bleeding event other than heavy menstrual bleeding<br>- 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.