Abstract
The aim of the development of new combined hormonal contraceptive products is to reduce the incidence of adverse effects, increase the safety profile and to utilize specific non-contraceptive benefits while maintaining high contraceptive efficacy. The combination of the native estrogen estetrol (E4) and the progestin drospirenone (DRSP) represents a new formulation of combined hormonal contraception that promises a high level of safety due to the metabolic properties of both components.
The efficacy and safety profile of the product have been tested in several studies. Estetrol 15 mg/DRSP 3 mg in the 24/4 regimen provides highly effective contraception with a favorable bleeding profile characterized by episodes of planned bleeding with a minimum incidence of attacks of unplanned bleeding, together with a good safety profile.
This combination is accompanied by a high level of user satisfaction and minimal changes in body weight. The combination has limited effects on liver function and plasma lipid levels and carbohydrate metabolism.
The effect of the E4/DRSP combination on selected hemostatic parameters is significantly lower than that of comparator combined hormonal contraceptives containing ethinyl estradiol (EE) 20 mg/DRSP 3 mg and EE 30 mg/levonorgestrel 150 mg. Estetrol 15 mg/DRSP 3 mg provides a safe and effective contraceptive with a high user satisfaction and a favorable bleeding profile, while minimally affecting lipid and glucose metabolism and hemocoagulation parameters.