Status:
COMPLETED
Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
Lead Sponsor:
Cardioangiologisches Centrum Bethanien
Conditions:
Heavy Menstrual Bleeding
Eligibility:
FEMALE
18-50 years
Brief Summary
Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs)
Detailed Description
Patients will be treated as standard of care, no randomization schedule, no blinded investigational product (IP). The decision which DOAC will be given is made before the subject will enter the trial...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04477837
Start Date
October 15 2020
End Date
June 15 2024
Last Update
August 21 2024
Active Locations (1)
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1
Cardioangiology Center Bethanien (CCB)
Frankfurt am Main, Germany, 60389