Clinical Trials Logo
  1. Home
  2. Heavy Menstrual Bleeding
  3. NCT04477837

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 Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04477837
Study type Observational [Patient Registry]
Source Cardioangiologisches Centrum Bethanien
Contact
Status Active, not recruiting
Phase
Start date October 15, 2020
Completion date June 15, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT02934789 - Effectiveness of Truclear on Patient Quality of Life N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Recruiting NCT04959396 - IUB SEAD RED (Revolutionary Endometrial Ablation Device Study N/A
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Recruiting NCT06064851 - Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients N/A
Terminated NCT04132349 - Ulipristal Acetate in Symptomatic Uterine Fibroid Phase 4
Completed NCT00386308 - Efficacy and Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT03412890 - LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Completed NCT05176496 - A Study Called Champion-HMB to Learn More About Females With Heavy Menstrual Bleeding and Available Treatments to Enable Earlier Diagnosis and to Predict Courses of Treatment
Completed NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed NCT00401193 - Efficacy and Safety of XP12B in Women With Menorrhagia Phase 3
Completed NCT03317795 - Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids Phase 4
Completed NCT02943655 - Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause Phase 3
Completed NCT03070951 - Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Completed NCT05406960 - Therapeutic Effect of Herbal Infusion on Menometrorrhagia N/A
Not yet recruiting NCT05079815 - Heavy Menstrual Bleeding and Iron Deficiency Anemia
Active, not recruiting NCT02449304 - Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device Phase 4
Terminated NCT02001324 - HMB- Data Collection Methods N/A
Enrolling by invitation NCT06122363 - Impact of Incomplete Endometrial Ablation