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Phase 4Not yet recruiting

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

Sponsor
University Of Debrecen (Industry)
Enrolment
350 planned
Conditions
Venous Thromboembolism Risk associated with Hormonal Contraceptives; Intrauterine contraception; Oral contraception; Contraception; Clinical trial healthy volunteer
Interventions
LEVONORGESTREL; DESOGESTREL; Tri-Regol bevont tabletta; DROSPIRENONE; ESTRADIOL HEMIHYDRATE; ESTETROL; ETHINYLESTRADIOL; NOMEGESTROL ACETATE
Ages
adults
Registry
CTIS2026-527084-15-00

Full record on the EU Clinical Trials Information System

From the registry

Main objective: This proposal focuses on evaluating thrombin generation and thrombosis risk in women on different forms of hormonal contraceptives, with a particular emphasis on modifiable risk factors that influence thrombosis risk. The study aims to identify actionable predictors for VTE risk, paving the way for personalized risk assessment and management strategies.To assess thrombin generation profiles and prethrombotic state in women using different formulations of hormonal contraceptives.To compare thrombin generation parameters between HC users and non-users.

Primary outcomes

  • 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 (H

History

  1. Registered