Heavy Menstrual BleedingNCT04477837
Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
An observational study of Heavy Menstrual Bleeding, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial summary
Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs) Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- What is being tested?
- Apixaban 5 MG, Rivaroxaban 20 MG and Edoxaban 60 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2020to 15 Jun 2024
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Expected number of patients estimated by study duration n=150 patients treated with direct oral anticoagulants (DOAC) due to venous thromboembolism.
Who may be able to join
- 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
Who cannot join
- Hysterectomy or ovariectomy
- Known heavy menstrual bleeding
- Hormonal contraceptives
- Hormone replacement therapy
- Use of hormone releasing intrauterine System (IUS)
- Contraindications to treatment with DOACs
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs)
Read the 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).
- Conditions
- Heavy Menstrual Bleeding
- Being tested
- Apixaban 5 MG, Rivaroxaban 20 MG, Edoxaban 60 MG, Dabigatran 150 Mg Oral Capsule
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 5 MGDrug
Also called Eliquis
frequency of heavy menstrual bleeding
Rivaroxaban 20 MGDrug
Also called Xarelto
frequency of heavy menstrual bleeding
Edoxaban 60 MGDrug
Also called Lixiana
frequency of heavy menstrual bleeding
Dabigatran 150 Mg Oral CapsuleDrug
Also called Pradaxa
frequency of heavy menstrual bleeding
| Study group | Role | What they receive |
|---|---|---|
| direct oral anticoagulant (DOAC) No.1 | Apixaban 5mg, oral, twice daily for at least four months Receives: Drug: Apixaban 5 MG | |
| direct oral anticoagulant (DOAC) No.2 | Rivaroxaban 20mg, oral, once daily for at least four months Receives: Drug: Rivaroxaban 20 MG | |
| direct oral anticoagulant (DOAC) No.3 | Edoxaban 60mg, oral, once daily for at least four months Receives: Drug: Edoxaban 60 MG | |
| direct oral anticoagulant (DOAC) No.4 | Dabigatran 150mg, oral, twice daily for at least four months Receives: Drug: Dabigatran 150 Mg Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary observation point (for all patients)
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)
Measured: baseline and monthly up to month 4
Secondary outcomes (1)
Secondary observation points (for all patients)
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
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Oct 2020
- Primary completion31 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. E. Lindhoff-Last, Cardioangiologisches Centrum Bethanien
- Investigators
- Edelgard Lindhoff-Last, Prof., Principal investigator, Cardioangiologisches Zentrum Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477837
- Sponsor's protocol ID
- HEMBLED
- Status last verified
- Aug 2024
- First submitted
- 14 Jul 2020
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04477837
- Acronym / sponsor ID
- HEMBLED
- Conditions
- Heavy Menstrual Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| direct oral anticoagulant (DOAC) No.1 | – | Drug: Apixaban 5 MGApixaban 5mg, oral, twice daily for at least four months |
| direct oral anticoagulant (DOAC) No.2 | – | Drug: Rivaroxaban 20 MGRivaroxaban 20mg, oral, once daily for at least four months |
| direct oral anticoagulant (DOAC) No.3 | – | Drug: Edoxaban 60 MGEdoxaban 60mg, oral, once daily for at least four months |
| direct oral anticoagulant (DOAC) No.4 | – | Drug: Dabigatran 150 Mg Oral CapsuleDabigatran 150mg, oral, twice daily for at least four months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Expected number of patients estimated by study duration n=150 patients treated with direct oral anticoagulants (DOAC) due to venous thromboembolism.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Hysterectomy or ovariectomy
- Known heavy menstrual bleeding
- Hormonal contraceptives
- Hormone replacement therapy
- Use of hormone releasing intrauterine System (IUS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixaban 5 MGAlso: Eliquisfrequency of heavy menstrual bleeding | Drug | direct oral anticoagulant (DOAC) No.1 |
| Rivaroxaban 20 MGAlso: Xareltofrequency of heavy menstrual bleeding | Drug | direct oral anticoagulant (DOAC) No.2 |
| Edoxaban 60 MGAlso: Lixianafrequency of heavy menstrual bleeding | Drug | direct oral anticoagulant (DOAC) No.3 |
| Dabigatran 150 Mg Oral CapsuleAlso: Pradaxafrequency of heavy menstrual bleeding | Drug | direct oral anticoagulant (DOAC) No.4 |
Primary outcome
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)
1 secondary outcome
Secondary observation points (for all patients)
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edelgard Lindhoff-Last, Prof. principal investigator
Cardioangiologisches Zentrum Bethanien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heavy Menstrual Bleeding, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary observation point (for all patients) (time frame: baseline and monthly up to month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.