Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
- Conditions
- Heavy Menstrual Bleeding
- Registration Number
- NCT04477837
- Lead Sponsor
- Cardioangiologisches Centrum Bethanien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Women with venous thromboembolism<br><br> - Age: 18 - 50 years<br><br> - Regular menstrual bleeding<br><br> - Treatment with DOACs for at least 7 days before inclusion<br><br> - Full therapeutic anticoagulation with rivaroxaban 1 x 20 mg, apixaban 2 x 5 mg,<br> edoxaban 60mg once daily or dabigatran 2 x 150mg for at least the next four months<br><br> - Written informed consent<br><br>Exclusion Criteria:<br><br> - Hysterectomy or ovariectomy<br><br> - Known heavy menstrual bleeding<br><br> - Hormonal contraceptives<br><br> - Hormone replacement therapy<br><br> - Use of hormone releasing intrauterine System (IUS)<br><br> - Contraindications to treatment with DOACs<br><br> - Treatment with rivaroxaban 15 mg twice daily (first three weeks after diagnosis of<br> venous thrombosis) or apixaban 10 mg twice daily (first week after diagnosis of<br> venous thrombosis)<br><br> - Treatment with rivaroxaban (10 mg or 15 mg once daily) or apixaban (2,5 mg twice<br> daily) in reduced therapeutic dosages<br><br> - Participation in any other trial
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary observation point (for all patients)
- Secondary Outcome Measures
Name Time Method Secondary observation points (for all patients)