Not Yet RecruitingPhase 4ACTRN12625001340426

DAME study: Dabigatran versus apixaban effect on heavy menstrual bleeding (HMB) evaluation in women of childbearing age


Sponsor

Te Whatu Ora/Health New Zealand

Enrollment

660 participants

Start Date

Jan 5, 2026

Study Type

Interventional

Conditions

Summary

Heavy menstrual bleeding (HMB) in women of childbearing age on anticoagulation is likely under-reported, but is a significant issue. Studies to date suggest that oral factor Xa inhibitors may be associated with a higher risk of HMB than direct thrombin inhibitors, and that dabigatran is likely to be associated with less HMB than apixaban, however more data is required to confirm this. If a particular class of anticoagulant can be demonstrated to have a lower incidence of HMB, then this could be useful to guide clinicians as to which anticoagulant to use in women of childbearing age requiring anticoagulation, particularly those who have pre-existing issues with HMB. We aim to prospectively collect data on women of childbearing age on anticoagulation for VTE (venous thromboembolism), recording their menstrual bleeding both at baseline and after six months of anticoagulation. We will compare HMB rates on dabigatran and apixaban. The data on apixaban will be collected mainly from our collaborating centre/s in the UK and Australia, as apixaban is not funded for VTE in NZ.


Eligibility

Sex: FemalesMin Age: 16 Yearss

Inclusion Criteria1

  • Menstruating women/adolescents aged 16 years or older with acute symptomatic venous thromboembolism, provoked or unprovoked, being treated with full dose apixaban or dabigatran for a minimum of three months duration.

Exclusion Criteria7

  • Pregnant/breastfeeding women
  • Post-menopausal women
  • CreCl <25ml/min for apixaban group, Cre Cl 2x ULN
  • Platelets <50
  • Patients already on anticoagulation or antiplatelet agents prior to new VTE event
  • Planned courses of anticoagulation for <6 months
  • Patients receiving treatment with reduced doses of anticoagulants or variations in treatment dosing or duration including LMWH

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Interventions

All patients enrolled in NZ will receive Clexane treatment dose 1mg/kg BD or 1.5mg/kg once daily (subcutaneous) for five days then oral dabigatran 150mg BD for 3-6 months. Adherence will not be fo

All patients enrolled in NZ will receive Clexane treatment dose 1mg/kg BD or 1.5mg/kg once daily (subcutaneous) for five days then oral dabigatran 150mg BD for 3-6 months. Adherence will not be formerly assessed.


Locations(1)

ACT,NSW,QLD,VIC, Australia

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