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

NCT04477837 | Completed DMC

• 1 other identifier: HEMBLED
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary observation points (for all patients)

  up to 16 weeks

Study Arms (4)

direct oral anticoagulant (DOAC) No.1

Apixaban 5mg, oral, twice daily for at least four months

Drug: Apixaban 5 MG

direct oral anticoagulant (DOAC) No.2

Rivaroxaban 20mg, oral, once daily for at least four months

Drug: Rivaroxaban 20 MG

direct oral anticoagulant (DOAC) No.3

Edoxaban 60mg, oral, once daily for at least four months

Drug: Edoxaban 60 MG

direct oral anticoagulant (DOAC) No.4

Dabigatran 150mg, oral, twice daily for at least four months

Drug: Dabigatran 150 Mg Oral Capsule

Interventions

Apixaban 5 MG DRUG

frequency of heavy menstrual bleeding

Also known as: Eliquis

direct oral anticoagulant (DOAC) No.1

Rivaroxaban 20 MG DRUG

frequency of heavy menstrual bleeding

Also known as: Xarelto

direct oral anticoagulant (DOAC) No.2

Edoxaban 60 MG DRUG

frequency of heavy menstrual bleeding

Also known as: Lixiana

direct oral anticoagulant (DOAC) No.3

Dabigatran 150 Mg Oral Capsule DRUG

frequency of heavy menstrual bleeding

Also known as: Pradaxa

direct oral anticoagulant (DOAC) No.4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Expected number of patients estimated by study duration n=150 patients treated with direct oral anticoagulants (DOAC) due to venous thromboembolism.

You may qualify if:

• Women with venous thromboembolism
• Age: 18 - 50 years
• Regular menstrual bleeding
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardioangiologisches Centrum Bethanien: lead

Study Sites (1)

Cardioangiology Center Bethanien (CCB)

Frankfurt am Main, 60389, Germany

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

apixaban; Rivaroxaban; edoxaban; Dabigatran

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Edelgard Lindhoff-Last, Prof.

  Cardioangiologisches Zentrum Bethanien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 20, 2020
• Study Start: October 15, 2020
• Primary Completion: May 31, 2024
• Study Completion: June 15, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)