- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04477837
Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Incidence of Heavy Menstrual Bleeding in Women of Reproductive Age Treated With Direct Oral Anticoagulants Because of Venous Thromboembolism
Study Overview
Status
Conditions
Intervention / Treatment
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. The DOAC has to be taken at least for seven days.
The registry is non-interventional (NIS) with routine blood draw at baseline and at month 4 after inclusion. The prospective follow up will be up to four months. Three consecutive menstrual bleeding cycles will be documented by the participating patients at home. One baseline data reporting and one follow up reporting after four months are planned in the participating coagulation centers.
The primary aim is the comparison of the frequency of heavy menstrual bleeding in female patients of reproductive age anticoagulated with DOACs using a modified pictorial blood loss assessment chart.
Secondary aims are the prevalence of von Willebrand disease in young anticoagulated female patients and correlation of HMB with age, International Society of Thrombosis and Hemostasis bleeding assessment tool at inclusion, Blood group, anatomical reasons i.e. underlying uterine pathologies, i. e. presence of uterine fibroids, endometrial polyps and/or adenomyosis, occurrence of iron deficiency, hemoglobin level and intermittent use of non-steroidal anti-inflammatory drug (NSAID).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Frankfurt am Main, Germany, 60389
- Cardioangiology Center Bethanien (CCB)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
direct oral anticoagulant (DOAC) No.1
Apixaban 5mg, oral, twice daily for at least four months
|
frequency of heavy menstrual bleeding
Other Names:
|
direct oral anticoagulant (DOAC) No.2
Rivaroxaban 20mg, oral, once daily for at least four months
|
frequency of heavy menstrual bleeding
Other Names:
|
direct oral anticoagulant (DOAC) No.3
Edoxaban 60mg, oral, once daily for at least four months
|
frequency of heavy menstrual bleeding
Other Names:
|
direct oral anticoagulant (DOAC) No.4
Dabigatran 150mg, oral, twice daily for at least four months
|
frequency of heavy menstrual bleeding
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary observation point (for all patients)
Time Frame: baseline and monthly up to month 4
|
Frequency of heavy menstrual bleeding in anticoagulated female patients of reproductive Age using a modified Pictorial blood loss assessment Chart (PBAC)-Score (Higham, Br J Obstet Gynaecol 1990; 97: 734-9)
|
baseline and monthly up to month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary observation points (for all patients)
Time Frame: up to 16 weeks
|
Correlation of heavy menstrual bleeding with von Willebrand's disease; Age; ISTH-BAT-Score at inclusion; blood Group; anatomical reasons i.e. underlying uterine pathologies, i.e. presence of uterine fibroids, endometrial polyps and/or adenomyosis; iron deficiency; hemoglobin level; intermittent use of NSAR
|
up to 16 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Edelgard Lindhoff-Last, Prof., Cardioangiologisches Zentrum Bethanien
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Uterine Diseases
- Menstruation Disturbances
- Uterine Hemorrhage
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Hemorrhage
- Menorrhagia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
- Dabigatran
- Apixaban
- Edoxaban
Other Study ID Numbers
- HEMBLED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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