E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Heavy menstrual bleeding associated with direct oral anticoagulants in premenopausal women. |
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E.1.1.1 | Medical condition in easily understood language |
Heavy menstrual bleeding associated with direct oral anticoagulants in premenopausal women. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027313 |
E.1.2 | Term | Menorrhagia |
E.1.2 | System Organ Class | 100000004872 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053468 |
E.1.2 | Term | Anticoagulant therapy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Three menstrual cycles after randomisation. |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Three menstrual cycles after randomisation. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Continuation with factor Xa-inhibitor. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the last patient's last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |