Комбинированные оральные контрацептивы, содержащие эстетрол: снижение риска тромбоза и другие преимущества

Подзолкова Н.М., Коренная В.В., Сумятина Л.В., Голубенко Е.О. Комбинированные оральные контрацептивы, содержащие эстетрол: снижение риска тромбоза и другие преимущества. Гинекология. 2025;27(3):190–197. DOI: 10.26442/20795696.2025.3.203320

© ООО «КОНСИЛИУМ МЕДИКУМ», 2025 г.

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Podzolkova NM, Korennaya VV, Sumyatina LV, Golubenko EO. Combined oral contraceptives with estetrol: Reduced risk of thrombosis and other benefits. A review. Gynecology. 2025;27(3):190–197. DOI: 10.26442/20795696.2025.3.203320

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Аннотация

Демографические тенденции указывают на сокращение числа детей, рожденных одной женщиной, изменение репродуктивных моделей и поздний возраст материнства, что повышает значимость эффективной контрацепции. Статья посвящена изучению современных тенденций использования комбинированных оральных контрацептивов (КОК), содержащих эстетрол (E4), новый эстроген, выделяемый плодом во время беременности. Основное внимание уделяется уникальному фармакологическому профилю E4, его воздействию на различные ткани и органы женского организма, а также потенциальным преимуществам перед традиционными синтетическими эстрогенами, такими как этинилэстрадиол. Отличительной чертой E4 является его способность избирательно воздействовать на разные типы тканей и органов, что снижает риск развития побочных эффектов, в том числе повышенного тромбообразования. Исследования показывают, что E4 оказывает минимальное влияние на систему гемостаза, уменьшая риск венозных тромбоэмболических осложнений, связанных с приемом традиционных КОК. Доклинические и клинические исследования подтверждают отсутствие пролиферативного эффекта E4 на клетки рака молочной железы, что делает его перспективным кандидатом для разработки новых препаратов – селективных модуляторов эстрогеновых рецепторов. Прием КОК с E4 не сопровождается значительными изменениями в метаболическом профиле, что обеспечивает контроль над весом и поддерживает стабильность артериального давления. Многоцентровые исследования подтвердили высокую эффективность и приемлемость КОК с E4, демонстрируя низкий процент серьезных нежелательных явлений и высокую степень удовлетворенности пользователей.

Ключевые слова: комбинированные оральные контрацептивы, эстрогены, эстетрол, гемостаз

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Demographic trends indicate a decrease in the number of children per woman, a change in reproductive patterns and a late age of motherhood. These factors increase the importance of effective contraception. The article is devoted to the study of current trends in the use of combined oral contraceptives (COCs) with estherol (E4). E4 is a new estrogen secreted by the fetus during pregnancy. The focus is on estherol's unique pharmacological profile, its effects on various tissues and organs of the female body, as well as its potential advantages over traditional synthetic estrogens such as ethinyl estradiol. A distinctive feature of E4 is its ability to selectively affect different types of tissues and organs, which reduces the risk of side effects. E4 has minimal effect on the hemostasis system, reduces the risk of venous thromboembolic complications. Preclinical and clinical studies confirm the absence of a proliferative effect of E4 on breast cancer cells, which makes it a promising candidate for the development of new selective estrogen receptor modulators. Taking COCs with E4 is not accompanied by significant changes in the metabolic profile, provides weight control and maintains blood pressure stability. Multicenter studies have confirmed the high efficacy and acceptability of COCs with E4, a low percentage of serious adverse events, and a high degree of user satisfaction.

Keywords: combined oral contraceptives, estrogens, estherol, hemostasis

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1. Vollset SE, Goren E, Yuan CW, et al. Fertility, mortality, migration, and population scenarios for 195 countries and territories from 2017 to 2100: A forecasting analysis for the Global Burden of Disease Study. Lancet. 2020;396(10258):1285-306. DOI:10.1016/S0140-6736(20)30677-2
2. Obshchie itogi estestvennogo dvizheniia naseleniia Rossiiskoi Federatsii. 2025. Available at: http://ssl.rosstat.gov.ru/storage/mediabank/EDN_02-2025.htm. Accessed: 05.06.2025 (in Russian).
3. Bozzaro C. Is egg freezing a good response to socioeconomic and cultural factors that lead women to postpone motherhood? Reprod Biomed Online. 2018;36(5):594-603. DOI:10.1016/j.rbmo.2018.01.018
4. Konstitutsiia Rossiiskoi Federatsii. St. 38, 41. Available at: http://kremlin.ru/acts/constitution/item#chapter2. Accessed: 05.06.2025 (in Russian).
5. Ob osnovakh okhrany zdorov'ia grazhdan v Rossiiskoi Federatsii. Federal'nyi zakon №323-FZ ot 21.11.2011. St. 35–37. Available at: https://www.consultant.ru/document/cons_doc_LAW_121895/ Accessed: 05.06.2025 (in Russian).
6. Bitzer J, Simon JA. Current issues and available options in combined hormonal contraception. Contraception. 2011;84:342-56. DOI:10.1016/j.contraception.2011.02.013
7. Both S, Lew-Starowicz M, Luria M, et al. Hormonal contraception and female sexuality: Position statements from the European Society of Sexual Medicine (ESSM). J Sex Med. 2019;16(11):1681-95. DOI:10.1016/j.jsxm.2019.08.005
8. Gallo MF, Lopez LM, Grimes DA, et al. Combination contraceptives: Effects on weight. Cochrane Database Syst Rev. 2006;1:CD003987. DOI:10.1002/14651858.CD003987.pub2
9. Teal S, Edelman A. Contraception selection, effectiveness, and adverse effects: A review. JAMA. 2021;326(24):2507-18. DOI:10.1001/jama.2021.21392
10. de Wit AE, Booij SH, Giltay EJ, et al. Association of use of oral contraceptives with depressive symptoms among adolescents and young women. JAMA Psychiatry. 2020;77(1):52-9. DOI:10.1001/jamapsychiatry.2019.2838
11. Rosano GMC, Rodriguez-Martinez MA, Spoletini I, Regidor PA. Obesity and contraceptive use: Impact on cardiovascular risk. ESC Heart Fail. 2022;9(6):3761-7. DOI:10.1002/ehf2.14104
12. Chen MJ, Jensen JT, Kaunitz AM, et al. Tolerability and safety of the estetrol/drospirenone combined oral contraceptive: Pooled analysis of two multicenter, open-label phase 3 trials. Contraception. 2022;116:44-50. DOI:10.1016/j.contraception.2022.10.004
13. Oedingen C, Scholz S, Razum O. Systematic review and meta-analysis of the association of combined oral contraceptives on the risk of venous thromboembolism: The role of the progestogen type and estrogen dose. Thromb Res. 2018;165:68-78. DOI:10.1016/j.thromres.2018.03.005
14. Gérard C, Foidart J-M. Estetrol: From preclinical to clinical pharmacology and advances in the understanding of the molecular mechanism of action. Drugs R D. 2023;23(2):77-92. DOI:10.1007/s40268-023-00419-5
15. Prilepskaya VN, Iurova MV. Estetrol: A new word in modern hormonal contraception. A review. Gynecology. 2024;26(2):108-18 (in Russian). DOI:10.26442/20795696.2024.2.202621
16. Foidart JM, Gaspard U, Pequeux C, et al. Unique vascular benefits of estetrol, a Native Fetal Estrogen with Specific Actions in Tissues (NEST). In: Brinton RD, Genazzani AR, Simoncini T, Stevenson JC, eds. Sex steroids’ effects on brain, heart and vessels. Vol. 6: Frontiers in Gynecological Endocrinology. Cham: Springer International Publishing, 2019. DOI:10.1007/978-3-030-11355-1_12
17. Fruzzetti F, Fidecicchi T, Montt Guevara MM, Simoncini T. Estetrol: A new choice for contraception. J Clin Med. 2021;10(23):5625. DOI:10.3390/jcm10235625
18. Holinka CF, Diczfalusy E, Coelingh Bennink HJT. Estetrol: A unique steroid in human pregnancy. J Steroid Biochem Mol Biol. 2008;110(1-2):138-43. DOI:10.1016/j.jsbmb.2008.03.027
19. Coelingh Bennink F, Holinka CF, Visser M, Coelingh Bennink HJT. Maternal and fetal estetrol levels during pregnancy. Climacteric. 2008;11(Suppl. 1):69-72. DOI:10.1080/13697130802056321
20. Creinin MD, Cagnacci A, Spaczyński RZ, et al. Experts’ view on the role of oestrogens in combined oral contraceptives: Emphasis on oestetrol (E4). Front Glob Womens Health. 2024;5:1395863. DOI:10.3389/fgwh.2024.1395863
21. Abot A, Fontaine C, Buscato M, et al. The uterine and vascular actions of estetrol delineate a distinctive profile of estrogen receptor α modulation, uncoupling nuclear and membrane activation. EMBO Mol Med. 2014;6(10):1328-46. DOI:10.15252/emmm.201404112
22. Kopec AK, Luyendyk JP. Coagulation in liver toxicity and disease: role of hepatocyte tissue factor. Thromb Res. 2014;133(Suppl. 1):S57-9.
23. Morimont L, Jost M, Gaspard U, et al. Low thrombin generation in users of a contraceptive containing estetrol and drospirenone. J Clin Endocrinol Metab. 2022;108:135-43.
24. Douxfils J, Morimont L, Bouvy C. Oral contraceptives and venous thromboembolism: focus on testing that may enable prediction and assessment of the risk. Semin Thromb Hemost. 2020;46:872-86.
25. Morimont L, Haguet H, Dogné J-M, et al. Combined oral contraceptives and venous thromboembolism: Review and perspective to mitigate the risk. Front Endocrinol (Lausanne). 2021;12:769187. DOI:10.3389/fendo.2021.769187
26. Akinshina SV, Koloda YuA. The effect of a new contraceptive with estetrol on the thrombotic safety profile of hormonal contraception. Akusherstvo i Ginekologiya = Obstetrics and Gynecology. 2022;10:159-68 (in Russian). DOI:10.18565/aig.2022.10.159-168
27. Bagot CN, Marsh MS, Whitehead M, et al. The effect of estrone on thrombin generation may explain the different thrombotic risk between oral and transdermal hormone replacement therapy. J Thromb Haemost. 2010;8(8):1736-44. DOI:10.1111/j.1538-7836.2010.03953.x
28. Canonico M, Bouaziz E, Carcaillon L, et al.; Estrogen and Thromboembolism Risk (ESTHER) Study Group. Synergism between oral estrogen therapy and cytochrome P450 3A5*1 allele on the risk of venous thromboembolism among postmenopausal women. J Clin Endocrinol Metab. 2008;93(8):3082-7. DOI:10.1210/jc.2008-0450
29. Didembourg M, Locquet M, Raskin L, et al. Lower reporting of venous thromboembolisms events with natural estrogen-based combined oral contraceptives compared to ethinylestradiol-containing pills: A disproportionality analysis of the Eudravigilance database. Contraception. 2025;142:110727. DOI:10.1016/j.contraception.2024.110727
30. Kluft C, Zimmerman Y, Mawet M, et al. Reduced hemostatic effects with drospirenone-based oral contraceptives containing estetrol vs. ethinyl estradiol. Contraception. 2017;95(2):140-7. DOI:10.1016/j.contraception.2016.08.018
31. Mawet M, Maillard C, Klipping C, et al. Unique effects on hepatic function, lipid metabolism, bone and growth endocrine parameters of estetrol in combined oral contraceptives. Eur J Contracept Reprod Health Care. 2015;20(6):463-75. DOI:10.3109/13625187.2015.1068934
32. Montt-Guevara MM, Palla G, Spina S, et al. Regulatory effects of estetrol on the endothelial plasminogen pathway and endothelial cell migration. Maturitas. 2017;99:1-9. DOI:10.1016/j.maturitas.2017.02.005
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Авторы

Н.М. Подзолкова*^1,2, В.В. Коренная^1,3, Л.В. Сумятина¹, Е.О. Голубенко¹

¹ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
²ГБУЗ г. Москвы «Московский многопрофильный научно-клинический центр им. С.П. Боткина» Департамента здравоохранения г. Москвы, Москва, Россия;
³ГБУЗ «Городская клиническая больница №52» Департамента здравоохранения г. Москвы, Москва, Россия
*PodzolkovaNM@rmapo.ru

________________________________________________

Natalia M. Podzolkova*^1,2, Vera V. Korennaya^1,3, Liliana V. Sumyatina¹, Ekaterina O. Golubenko¹

¹Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
²Botkin Moscow Multidisciplinary Research and Clinical Center, Moscow, Russia;
³City Clinical Hospital No. 52, Moscow, Russia
*PodzolkovaNM@rmapo.ru

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