Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants

Heavy Menstrual Bleeding Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04477837
• Other study ID #: HEMBLED
• Status: Active, not recruiting
• Start date: October 15, 2020
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Cardioangiologisches Centrum Bethanien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs)

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 15, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Menorrhagia

Intervention

Drug:
• Apixaban 5 MG
frequency of heavy menstrual bleeding
• Rivaroxaban 20 MG
frequency of heavy menstrual bleeding
• Edoxaban 60 MG
frequency of heavy menstrual bleeding
• Dabigatran 150 Mg Oral Capsule
frequency of heavy menstrual bleeding

Locations

Country	Name	City	State
Germany	Cardioangiology Center Bethanien (CCB)	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Cardioangiologisches Centrum Bethanien

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline and monthly up to month 4
Secondary	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	up to 16 weeks