Heavy menstrual bleeding in premenopausal women treated with direct oral anticoagulants - a randomised controlled trial.

Phase 4

Completed

Conditions: heavy menstrual bleeding
Menorrhagia
10064477

Registration Number: NL-OMON55056

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 110

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

- 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in pictorial bleeding assessment chart (PBAC)-score, a validated<br /><br>score for assessing HMB, before randomisation (i.e. while on factor Xa<br /><br>treatment) compared to the PBAC-score after randomisation. The primary analysis<br /><br>is a comparison of the mean PBAC-score before randomization (i.e. while on<br /><br>factor Xa treatment) with the mean PBAC-score after the participant has<br /><br>switched to dabigatran.</p><br>

Secondary Outcome Measures

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