Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral… (NCT04477837) | Clinical Trial Compass
CompletedNot Applicable
Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
Germany84 participantsStarted 2020-10-15
Plain-language summary
Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs)
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* Women with venous thromboembolism
* Age: 18 - 50 years
* Regular menstrual bleeding
* Treatment with DOACs for at least 7 days before inclusion
* Full therapeutic anticoagulation with rivaroxaban 1 x 20 mg, apixaban 2 x 5 mg, edoxaban 60mg once daily or dabigatran 2 x 150mg for at least the next four months
* Written informed consent
Exclusion Criteria:
* Hysterectomy or ovariectomy
* Known heavy menstrual bleeding
* Hormonal contraceptives
* Hormone replacement therapy
* Use of hormone releasing intrauterine System (IUS)
* Contraindications to treatment with DOACs
* Treatment with rivaroxaban 15 mg twice daily (first three weeks after diagnosis of venous thrombosis) or apixaban 10 mg twice daily (first week after diagnosis of venous thrombosis)
* Treatment with rivaroxaban (10 mg or 15 mg once daily) or apixaban (2,5 mg twice daily) in reduced therapeutic dosages
* Participation in any other trial