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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Cardioangiologisches Centrum Bethanien · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DRUG	Apixaban 5 MG	frequency of heavy menstrual bleeding
DRUG	Rivaroxaban 20 MG	frequency of heavy menstrual bleeding
DRUG	Edoxaban 60 MG	frequency of heavy menstrual bleeding
DRUG	Dabigatran 150 Mg Oral Capsule	frequency of heavy menstrual bleeding

Timeline

• Start date: 2020-10-15
• Primary completion: 2024-05-31
• Completion: 2024-06-15
• First posted: 2020-07-20
• Last updated: 2024-08-21

Locations

1 site across 1 country: Germany