Evaluation of Thrombin Generation and Thrombosis Risk in Women on Hormonal Contraceptives with a Focus on Modifiable Risk Factors

Condition studied

Venous Thromboembolism Risk associated with Hormonal Contraceptives

Investigational medicinal product(s)

Every trial of Levonorgestrel, Drospirenone and Estradiol across our registers →

Eligibility

Primary endpoint

The normalized activated protein C sensitivity ratio (nAPCsr), determined by calibrated automated thrombography (CAT) assay, evaluated as the quantifiable difference in group means (expressed as absolute and percentage differences with 95% confidence intervals) between each hormonal contraceptive (HC) user subgroup and the healthy non-user control group.

Endpoint detail

Evaluation of individual thrombin generation parameters, standard coagulation screening tests, routine laboratory parameters, and prothrombotic markers. Secondary outcomes also encompass markers of endothelial activation, fibrinolytic capacity, inflammatory cytokines/chemokines, and inherited thrombophilia screening. Furthermore, secondary analyses include the quantitative evaluation of the influence of modifiable risk factors on hemostatic balance and thrombosis risk across the study cohorts.