Safety and tolerability of a combined oral contraceptive containing estetrol/drospirenone in real-life clinical practice: An open-label, prospective, multicenter, epidemiological, observational program "Estetiko"

Aim. To evaluate the safety and acceptability of a combined oral contraceptive (COC) containing estetrol 15 mg and drospirenone 3 mg when taken for 6 cycles in real clinical practice. Materials and methods. An open-label prospective multicenter (in 20 cities of the Russian Federation) epidemiological observational program "Estetiko" ("Safety and tolerability of combined oral contraception in real clinical practice") was conducted from 01.11. 2023 to 21.08.2024. The data of 2495 participants aged 18 to 50 years who received a COC containing estetrol 15 mg and drospirenone 3 mg (E4/DRSP) for 6 cycles were analyzed. Results. The average age of women was 30.7±7 years. In comparison with the initial values, after 3 and 6 months of using COC E4/DRSP the following indicators remained stable (p0.05 for all comparisons): blood pressure (mmHg) – systolic (113.7±9.8, 112.6±9.8, 112.6±22.6) and diastolic (71.7±7.8, 71.0±7.3, 70.9±14.9), body mass index (kg/m2) – 23±3.6, 23±3.5, 23±3.5. Adverse events were noted after 3 months of using COC E4/DRSP in 611 (24.5%), after 6 months – in 204 (8.2%) women; there were mild adverse events in 91 and 96% of the participants respectively. The most frequently reported side effects after 3 and 6 months were: breast engorgement (17.2%; 7.5%), intermenstrual bleeding/spotting (11.5%; 6.1%), mood swings (10.3%; 5.4%), decreased libido (9.2%; 7.1%), headache (9.1%; 5.2%), nausea (8.4%; 4.6%). Less than 1% of women stopped taking E4/DRSP because of side effects. There were no serious adverse events. All patients had planned bleeding. There were no cases of pregnancy. 99.5% of study participants planned to continue taking E4/DRSP after 6 cycles. Conclusion. E4/DRSP is a COC with a high level of safety and a low incidence of adverse events; well tolerated, with a predictable bleeding pattern in most women. Satisfaction with the drug is high.