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Характеристика маточных кровотечений, возникающих при использовании орального контрацептива, содержащего дроспиренон в комбинации с эстетролом
Характеристика маточных кровотечений, возникающих при использовании орального контрацептива, содержащего дроспиренон в комбинации с эстетролом
Кузнецова И.В., Евсюкова Л.В. Характеристика маточных кровотечений, возникающих при использовании орального контрацептива, содержащего дроспиренон в комбинации с эстетролом. Гинекология. 2024;26(3):210–215. DOI: 10.26442/20795696.2024.3.202968
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
________________________________________________
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
Обоснование. Неблагоприятный паттерн кровотечений является частой причиной отказа от продолжения приема гормональной контрацепции.
Цель. Оценить характеристики маточных кровотечений при использовании нового комбинированного орального контрацептива (КОК), содержащего эстетрол и дроспиренон (Эстеретта®).
Материалы и методы. В многоцентровое наблюдательное исследование включены 1402 женщины в возрасте 18–49 лет, которые принимали КОК Эстеретта® в течение 6 циклов. Оценивались регулярность, длительность и обильность кровотечений отмены, а также частота непредсказуемых кровотечений.
Результаты. Частота регулярных кровотечений отмены составила 100%. Доля женщин с обильными менструациями/кровотечениями отмены уменьшилась с 29,6 до 10,07% (p<0,0001). Продолжительность регулярных кровотечений отмены достоверно снижалась (p=0,008). Частота непредсказуемых кровотечений в процессе приема КОК снизилась с 4,57 до 3,29% (p=0,05). Удовлетворительный контроль цикла наблюдался у 87,43% женщин. От продолжения использования КОК отказались 2,5% участниц.
Заключение. КОК Эстеретта® обеспечивает высокую частоту регулярных кровотечений отмены и низкую частоту непредсказуемых кровотечений. Учитывая оптимальный профиль безопасности, данный препарат может быть рекомендован как средство первого выбора для контрацепции у сексуально активных женщин, не планирующих беременность.
Ключевые слова: комбинированная гормональная контрацепция, побочные эффекты, паттерн кровотечений, эстетрол, дроспиренон, Эстеретта
Aim. To evaluate the characteristics of uterine bleeding when using a new combined oral contraceptive (COC) containing estetrol and drospirenone (Esteretta®).
Materials and methods. A multicenter observational study included 1402 females aged 18–49 who received Esteretta® for 6 cycles. The frequency, duration, and severity of withdrawal bleeding, as well as the frequency of unpredictable bleeding, were assessed.
Results. The rate of regular withdrawal bleeding was 100%. The proportion of women with heavy menstruation/withdrawal bleeding decreased from 29.6 to 10.07% (p<0.0001). The duration of regular withdrawal bleeding was significantly reduced (p=0.008). The incidence of unpredictable bleeding during COC use decreased from 4.57 to 3.29% (p=0.05). Satisfactory cycle control was observed in 87.43% of women. 2.5% of participants refused to continue using COCs.
Conclusion. Esteretta® provides a high rate of regular withdrawal bleeding and a low rate of unpredictable bleeding. Given the optimal safety profile, this drug may be the first choice for contraception in sexually active women who are not planning a pregnancy.
Keywords: combined hormonal contraception, side effects, bleeding pattern, estetrol, drospirenone, Esteretta
Цель. Оценить характеристики маточных кровотечений при использовании нового комбинированного орального контрацептива (КОК), содержащего эстетрол и дроспиренон (Эстеретта®).
Материалы и методы. В многоцентровое наблюдательное исследование включены 1402 женщины в возрасте 18–49 лет, которые принимали КОК Эстеретта® в течение 6 циклов. Оценивались регулярность, длительность и обильность кровотечений отмены, а также частота непредсказуемых кровотечений.
Результаты. Частота регулярных кровотечений отмены составила 100%. Доля женщин с обильными менструациями/кровотечениями отмены уменьшилась с 29,6 до 10,07% (p<0,0001). Продолжительность регулярных кровотечений отмены достоверно снижалась (p=0,008). Частота непредсказуемых кровотечений в процессе приема КОК снизилась с 4,57 до 3,29% (p=0,05). Удовлетворительный контроль цикла наблюдался у 87,43% женщин. От продолжения использования КОК отказались 2,5% участниц.
Заключение. КОК Эстеретта® обеспечивает высокую частоту регулярных кровотечений отмены и низкую частоту непредсказуемых кровотечений. Учитывая оптимальный профиль безопасности, данный препарат может быть рекомендован как средство первого выбора для контрацепции у сексуально активных женщин, не планирующих беременность.
Ключевые слова: комбинированная гормональная контрацепция, побочные эффекты, паттерн кровотечений, эстетрол, дроспиренон, Эстеретта
________________________________________________
Aim. To evaluate the characteristics of uterine bleeding when using a new combined oral contraceptive (COC) containing estetrol and drospirenone (Esteretta®).
Materials and methods. A multicenter observational study included 1402 females aged 18–49 who received Esteretta® for 6 cycles. The frequency, duration, and severity of withdrawal bleeding, as well as the frequency of unpredictable bleeding, were assessed.
Results. The rate of regular withdrawal bleeding was 100%. The proportion of women with heavy menstruation/withdrawal bleeding decreased from 29.6 to 10.07% (p<0.0001). The duration of regular withdrawal bleeding was significantly reduced (p=0.008). The incidence of unpredictable bleeding during COC use decreased from 4.57 to 3.29% (p=0.05). Satisfactory cycle control was observed in 87.43% of women. 2.5% of participants refused to continue using COCs.
Conclusion. Esteretta® provides a high rate of regular withdrawal bleeding and a low rate of unpredictable bleeding. Given the optimal safety profile, this drug may be the first choice for contraception in sexually active women who are not planning a pregnancy.
Keywords: combined hormonal contraception, side effects, bleeding pattern, estetrol, drospirenone, Esteretta
Полный текст
Список литературы
1. Bastianelli C, Farris M, Bruni V, et al. Effects of progestin-only contraceptives on the endometrium. Expert Rev Clin Pharmacol. 2020;13(10):1103-23. DOI:10.1080/17512433.2020.1821649
2. Abou-Ismail MY, Citla Sridhar D, Nayak L. Estrogen and thrombosis: A bench to bedside review. Thromb Res. 2020;92:40-51. DOI:10.1016/j.thromres.2020.05.008
3. Skeith L, Le Gal G, Rodger MA. Oral contraceptives and hormone replacement therapy: How strong a risk factor for venous thromboembolism? Thromb Res.
2021;202:134-8. DOI:10.1016/j.thromres.2021.03.012
4. Weill A, Dalichampt M, Raguideau F, et al. Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: cohort study. BMJ. 2016;353:i2002. DOI:10.1136/bmj.i2002
5. Allen RH. Combined estrogen-progestin oral contraceptives: Patient selection, counseling and use. Waltham (MA): UpToDate, 2023.
6. Rott H. Birth Control Pills and Thrombotic Risks: Differences of Contraception Methods with and without Estrogen. Hamostaseologie. 2019;39(1):42-8. DOI:10.1055/s-0039-1677806
7. Stocco B, Fumagalli HF, Franceschini SA, et al. Comparative study of the effects of combined oral contraceptives in hemostatic variables: an observational preliminary study. Medicine (Baltimore). 2015;94(4):e385. DOI:10.1097/MD.0000000000000385
8. Dinger J, Do Minh T, Heinemann K. Impact of estrogen type on cardiovascular safety of combined oral contraceptives. Contraception. 2016;94(4):328-39. DOI:10.1016/j.contraception.2016.06.010
9. Stanczyk FZ, Winer SA, Foidart JM, Archer DF. Comparison of estrogenic components used for hormonal contraception. Contraception. 2024;130:110310. DOI:10.1016/j.contraception.2023.110310
10. Douxfils J, Klipping C, Duijkers I, et al. Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters. Contraception. 2020;102(6):396-402. DOI:10.1016/j.contraception.2020.08.015
11. Gérard C, Foidart JM. 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
12. Morimont L, Haguet H, Dogné JM, 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
13. 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(1):135-43. DOI:10.1210/clinem/dgac511
14. Polis CB, Hussain R, Berry A. There might be blood: a scoping review on women’s responses to contraceptive-induced menstrual bleeding changes. Reprod Health. 2018;15(1):114. DOI:10.1186/s12978-018-0561-0
15. Mawet M, Nollevaux F, Nizet D, et al. Impact of a new levonorgestrel intrauterine system, Levosert(®), on heavy menstrual bleeding: results of a one-year randomised controlled trial. Eur J Contracept Reprod Health Care. 2014;19(3):169-79. DOI:10.3109/13625187.2014.894184
16. Rowe P, Farley T, Peregoudov A, et al. Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A. Contraception. 2016;93(6):498-506. DOI:10.1016/j.contraception.2016.02.024
17. Archer DF, Mansour D, Foidart JM. Bleeding Patterns of Oral Contraceptives with a Cyclic Dosing Regimen: An Overview. J Clin Med. 2022;11(15):4634. DOI:10.3390/jcm11154634
18. Critchley HOD, Maybin JA, Armstrong GM, Williams ARW. Physiology of the Endometrium and Regulation of Menstruation. Physiol Rev. 2020;100(3):1149-79. DOI:10.1152/physrev.00031.2019
19. Kuan KKW, Saunders PTK. Female Reproductive Systems: Hormone Dependence and Receptor Expression. Adv Exp Med Biol. 2022;1390:21-39. DOI:10.1007/978-3-031-11836-4_2
20. Burris TP, de Vera IMS, Cote I, et al. International Uni on of Basic and Clinical Pharmacology CXIII: Nuclear Receptor Superfamily-Update 2023. Pharmacol Rev. 2023;75(6):1233-318. DOI:10.1124/pharmrev.121.000436
21. Hirota Y. Progesterone governs endometrial proliferation-differentiation switching and blastocyst implantation. Endocr J. 2019;66(3):199-206. DOI:10.1507/endocrj.EJ18-0431
22. Patel B, Elguero S, Thakore S, et al. Role of nuclear progesterone receptor isoforms in uterine pathophysiology. Hum Reprod Update. 2015;21(2):155-73. DOI:10.1093/humupd/dmu056
23. Dinh A, Sriprasert I, Williams AR, Archer DF. A review of the endometrial histologic effects of progestins and progesterone receptor modulators in reproductive age women. Contraception. 2015;91(5):360-7. DOI:10.1016/j.contraception.2015.01.008
24. Gérard C, Arnal JF, Jost M, et al. Profile of estetrol, a promising native estrogen for oral contraception and the relief of climacteric symptoms of menopause. Expert Rev Clin Pharmacol. 2022;15(2):121-37. DOI:10.1080/17512433.2022.2054413
25. Klipping C, Duijkers I, Mawet M, et al. Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone. Contraception. 2021;103(4):213-21. DOI:10.1016/j.contraception.2021.01.001
26. Inoue K, Barratt A, Richters J. Does research into contraceptive method discontinuation address women’s own reasons? A critical review. J Fam Plann Reprod Health Care. 2015;41(4):292-9. DOI:10.1136/jfprhc-2014-100976
27. 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
28. Gaspard U, Taziaux M, Mawet M, et al. A multicenter, randomized study to sel ect the minimum effective dose of estetrol (E4) in postmenopausal women (E4Relief): part 1. Vasomotor symptoms and overall safety. Menopause. 2020;27(8):848-57. DOI:10.1097/GME.0000000000001561
29. Creinin MD, Westhoff CL, Bouchard C, et al. Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results. Contraception. 2021;104(3):222-8. DOI:10.1016/j.contraception.2021.05.002
30. Gemzell-Danielsson K, Apter D, Zatik J, et al. Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia. BJOG. 2022;129(1):63-71. DOI:10.1111/1471-0528.16840
31. Kaunitz AM, Achilles SL, Zatik J, et al. Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women. Contraception. 2022;116:29-36. DOI:10.1016/j.contraception.2022.07.010
32. Hoffman BL, Schorge JO, Bradshaw KD, et al. Williams Gynecology. 3rd Ed. New York: McGraw-Hill Professional, 2016.
33. Villavicencio J, Allen RH. Unscheduled bleeding and contraceptive choice: increasing satisfaction and continuation rates. Open Access J Contracept. 2016;7:43-52.
34. Foidart JM, Gemzell-Danielsson K, Kubba A, et al. The benefits of estetrol addition to drospirenone for contraception. AJOG Glob Rep. 2023;3(4):100266. DOI:10.1016/j.xagr.2023.100266
35. Seif MW, Diamond K, Nickkho-Amiry M. Obesity and menstrual disorders. Best Pract Res Clin Obstet Gynaecol. 2015;29(4):516-27. DOI:10.1016/j.bpobgyn.2014.10.010
2. Abou-Ismail MY, Citla Sridhar D, Nayak L. Estrogen and thrombosis: A bench to bedside review. Thromb Res. 2020;92:40-51. DOI:10.1016/j.thromres.2020.05.008
3. Skeith L, Le Gal G, Rodger MA. Oral contraceptives and hormone replacement therapy: How strong a risk factor for venous thromboembolism? Thromb Res.
2021;202:134-8. DOI:10.1016/j.thromres.2021.03.012
4. Weill A, Dalichampt M, Raguideau F, et al. Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: cohort study. BMJ. 2016;353:i2002. DOI:10.1136/bmj.i2002
5. Allen RH. Combined estrogen-progestin oral contraceptives: Patient selection, counseling and use. Waltham (MA): UpToDate, 2023.
6. Rott H. Birth Control Pills and Thrombotic Risks: Differences of Contraception Methods with and without Estrogen. Hamostaseologie. 2019;39(1):42-8. DOI:10.1055/s-0039-1677806
7. Stocco B, Fumagalli HF, Franceschini SA, et al. Comparative study of the effects of combined oral contraceptives in hemostatic variables: an observational preliminary study. Medicine (Baltimore). 2015;94(4):e385. DOI:10.1097/MD.0000000000000385
8. Dinger J, Do Minh T, Heinemann K. Impact of estrogen type on cardiovascular safety of combined oral contraceptives. Contraception. 2016;94(4):328-39. DOI:10.1016/j.contraception.2016.06.010
9. Stanczyk FZ, Winer SA, Foidart JM, Archer DF. Comparison of estrogenic components used for hormonal contraception. Contraception. 2024;130:110310. DOI:10.1016/j.contraception.2023.110310
10. Douxfils J, Klipping C, Duijkers I, et al. Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters. Contraception. 2020;102(6):396-402. DOI:10.1016/j.contraception.2020.08.015
11. Gérard C, Foidart JM. 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
12. Morimont L, Haguet H, Dogné JM, 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
13. 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(1):135-43. DOI:10.1210/clinem/dgac511
14. Polis CB, Hussain R, Berry A. There might be blood: a scoping review on women’s responses to contraceptive-induced menstrual bleeding changes. Reprod Health. 2018;15(1):114. DOI:10.1186/s12978-018-0561-0
15. Mawet M, Nollevaux F, Nizet D, et al. Impact of a new levonorgestrel intrauterine system, Levosert(®), on heavy menstrual bleeding: results of a one-year randomised controlled trial. Eur J Contracept Reprod Health Care. 2014;19(3):169-79. DOI:10.3109/13625187.2014.894184
16. Rowe P, Farley T, Peregoudov A, et al. Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A. Contraception. 2016;93(6):498-506. DOI:10.1016/j.contraception.2016.02.024
17. Archer DF, Mansour D, Foidart JM. Bleeding Patterns of Oral Contraceptives with a Cyclic Dosing Regimen: An Overview. J Clin Med. 2022;11(15):4634. DOI:10.3390/jcm11154634
18. Critchley HOD, Maybin JA, Armstrong GM, Williams ARW. Physiology of the Endometrium and Regulation of Menstruation. Physiol Rev. 2020;100(3):1149-79. DOI:10.1152/physrev.00031.2019
19. Kuan KKW, Saunders PTK. Female Reproductive Systems: Hormone Dependence and Receptor Expression. Adv Exp Med Biol. 2022;1390:21-39. DOI:10.1007/978-3-031-11836-4_2
20. Burris TP, de Vera IMS, Cote I, et al. International Uni on of Basic and Clinical Pharmacology CXIII: Nuclear Receptor Superfamily-Update 2023. Pharmacol Rev. 2023;75(6):1233-318. DOI:10.1124/pharmrev.121.000436
21. Hirota Y. Progesterone governs endometrial proliferation-differentiation switching and blastocyst implantation. Endocr J. 2019;66(3):199-206. DOI:10.1507/endocrj.EJ18-0431
22. Patel B, Elguero S, Thakore S, et al. Role of nuclear progesterone receptor isoforms in uterine pathophysiology. Hum Reprod Update. 2015;21(2):155-73. DOI:10.1093/humupd/dmu056
23. Dinh A, Sriprasert I, Williams AR, Archer DF. A review of the endometrial histologic effects of progestins and progesterone receptor modulators in reproductive age women. Contraception. 2015;91(5):360-7. DOI:10.1016/j.contraception.2015.01.008
24. Gérard C, Arnal JF, Jost M, et al. Profile of estetrol, a promising native estrogen for oral contraception and the relief of climacteric symptoms of menopause. Expert Rev Clin Pharmacol. 2022;15(2):121-37. DOI:10.1080/17512433.2022.2054413
25. Klipping C, Duijkers I, Mawet M, et al. Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone. Contraception. 2021;103(4):213-21. DOI:10.1016/j.contraception.2021.01.001
26. Inoue K, Barratt A, Richters J. Does research into contraceptive method discontinuation address women’s own reasons? A critical review. J Fam Plann Reprod Health Care. 2015;41(4):292-9. DOI:10.1136/jfprhc-2014-100976
27. 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
28. Gaspard U, Taziaux M, Mawet M, et al. A multicenter, randomized study to sel ect the minimum effective dose of estetrol (E4) in postmenopausal women (E4Relief): part 1. Vasomotor symptoms and overall safety. Menopause. 2020;27(8):848-57. DOI:10.1097/GME.0000000000001561
29. Creinin MD, Westhoff CL, Bouchard C, et al. Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results. Contraception. 2021;104(3):222-8. DOI:10.1016/j.contraception.2021.05.002
30. Gemzell-Danielsson K, Apter D, Zatik J, et al. Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia. BJOG. 2022;129(1):63-71. DOI:10.1111/1471-0528.16840
31. Kaunitz AM, Achilles SL, Zatik J, et al. Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women. Contraception. 2022;116:29-36. DOI:10.1016/j.contraception.2022.07.010
32. Hoffman BL, Schorge JO, Bradshaw KD, et al. Williams Gynecology. 3rd Ed. New York: McGraw-Hill Professional, 2016.
33. Villavicencio J, Allen RH. Unscheduled bleeding and contraceptive choice: increasing satisfaction and continuation rates. Open Access J Contracept. 2016;7:43-52.
34. Foidart JM, Gemzell-Danielsson K, Kubba A, et al. The benefits of estetrol addition to drospirenone for contraception. AJOG Glob Rep. 2023;3(4):100266. DOI:10.1016/j.xagr.2023.100266
35. Seif MW, Diamond K, Nickkho-Amiry M. Obesity and menstrual disorders. Best Pract Res Clin Obstet Gynaecol. 2015;29(4):516-27. DOI:10.1016/j.bpobgyn.2014.10.010
2. Abou-Ismail MY, Citla Sridhar D, Nayak L. Estrogen and thrombosis: A bench to bedside review. Thromb Res. 2020;92:40-51. DOI:10.1016/j.thromres.2020.05.008
3. Skeith L, Le Gal G, Rodger MA. Oral contraceptives and hormone replacement therapy: How strong a risk factor for venous thromboembolism? Thromb Res.
2021;202:134-8. DOI:10.1016/j.thromres.2021.03.012
4. Weill A, Dalichampt M, Raguideau F, et al. Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: cohort study. BMJ. 2016;353:i2002. DOI:10.1136/bmj.i2002
5. Allen RH. Combined estrogen-progestin oral contraceptives: Patient selection, counseling and use. Waltham (MA): UpToDate, 2023.
6. Rott H. Birth Control Pills and Thrombotic Risks: Differences of Contraception Methods with and without Estrogen. Hamostaseologie. 2019;39(1):42-8. DOI:10.1055/s-0039-1677806
7. Stocco B, Fumagalli HF, Franceschini SA, et al. Comparative study of the effects of combined oral contraceptives in hemostatic variables: an observational preliminary study. Medicine (Baltimore). 2015;94(4):e385. DOI:10.1097/MD.0000000000000385
8. Dinger J, Do Minh T, Heinemann K. Impact of estrogen type on cardiovascular safety of combined oral contraceptives. Contraception. 2016;94(4):328-39. DOI:10.1016/j.contraception.2016.06.010
9. Stanczyk FZ, Winer SA, Foidart JM, Archer DF. Comparison of estrogenic components used for hormonal contraception. Contraception. 2024;130:110310. DOI:10.1016/j.contraception.2023.110310
10. Douxfils J, Klipping C, Duijkers I, et al. Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters. Contraception. 2020;102(6):396-402. DOI:10.1016/j.contraception.2020.08.015
11. Gérard C, Foidart JM. 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
12. Morimont L, Haguet H, Dogné JM, 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
13. 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(1):135-43. DOI:10.1210/clinem/dgac511
14. Polis CB, Hussain R, Berry A. There might be blood: a scoping review on women’s responses to contraceptive-induced menstrual bleeding changes. Reprod Health. 2018;15(1):114. DOI:10.1186/s12978-018-0561-0
15. Mawet M, Nollevaux F, Nizet D, et al. Impact of a new levonorgestrel intrauterine system, Levosert(®), on heavy menstrual bleeding: results of a one-year randomised controlled trial. Eur J Contracept Reprod Health Care. 2014;19(3):169-79. DOI:10.3109/13625187.2014.894184
16. Rowe P, Farley T, Peregoudov A, et al. Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A. Contraception. 2016;93(6):498-506. DOI:10.1016/j.contraception.2016.02.024
17. Archer DF, Mansour D, Foidart JM. Bleeding Patterns of Oral Contraceptives with a Cyclic Dosing Regimen: An Overview. J Clin Med. 2022;11(15):4634. DOI:10.3390/jcm11154634
18. Critchley HOD, Maybin JA, Armstrong GM, Williams ARW. Physiology of the Endometrium and Regulation of Menstruation. Physiol Rev. 2020;100(3):1149-79. DOI:10.1152/physrev.00031.2019
19. Kuan KKW, Saunders PTK. Female Reproductive Systems: Hormone Dependence and Receptor Expression. Adv Exp Med Biol. 2022;1390:21-39. DOI:10.1007/978-3-031-11836-4_2
20. Burris TP, de Vera IMS, Cote I, et al. International Uni on of Basic and Clinical Pharmacology CXIII: Nuclear Receptor Superfamily-Update 2023. Pharmacol Rev. 2023;75(6):1233-318. DOI:10.1124/pharmrev.121.000436
21. Hirota Y. Progesterone governs endometrial proliferation-differentiation switching and blastocyst implantation. Endocr J. 2019;66(3):199-206. DOI:10.1507/endocrj.EJ18-0431
22. Patel B, Elguero S, Thakore S, et al. Role of nuclear progesterone receptor isoforms in uterine pathophysiology. Hum Reprod Update. 2015;21(2):155-73. DOI:10.1093/humupd/dmu056
23. Dinh A, Sriprasert I, Williams AR, Archer DF. A review of the endometrial histologic effects of progestins and progesterone receptor modulators in reproductive age women. Contraception. 2015;91(5):360-7. DOI:10.1016/j.contraception.2015.01.008
24. Gérard C, Arnal JF, Jost M, et al. Profile of estetrol, a promising native estrogen for oral contraception and the relief of climacteric symptoms of menopause. Expert Rev Clin Pharmacol. 2022;15(2):121-37. DOI:10.1080/17512433.2022.2054413
25. Klipping C, Duijkers I, Mawet M, et al. Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone. Contraception. 2021;103(4):213-21. DOI:10.1016/j.contraception.2021.01.001
26. Inoue K, Barratt A, Richters J. Does research into contraceptive method discontinuation address women’s own reasons? A critical review. J Fam Plann Reprod Health Care. 2015;41(4):292-9. DOI:10.1136/jfprhc-2014-100976
27. 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
28. Gaspard U, Taziaux M, Mawet M, et al. A multicenter, randomized study to sel ect the minimum effective dose of estetrol (E4) in postmenopausal women (E4Relief): part 1. Vasomotor symptoms and overall safety. Menopause. 2020;27(8):848-57. DOI:10.1097/GME.0000000000001561
29. Creinin MD, Westhoff CL, Bouchard C, et al. Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results. Contraception. 2021;104(3):222-8. DOI:10.1016/j.contraception.2021.05.002
30. Gemzell-Danielsson K, Apter D, Zatik J, et al. Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia. BJOG. 2022;129(1):63-71. DOI:10.1111/1471-0528.16840
31. Kaunitz AM, Achilles SL, Zatik J, et al. Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women. Contraception. 2022;116:29-36. DOI:10.1016/j.contraception.2022.07.010
32. Hoffman BL, Schorge JO, Bradshaw KD, et al. Williams Gynecology. 3rd Ed. New York: McGraw-Hill Professional, 2016.
33. Villavicencio J, Allen RH. Unscheduled bleeding and contraceptive choice: increasing satisfaction and continuation rates. Open Access J Contracept. 2016;7:43-52.
34. Foidart JM, Gemzell-Danielsson K, Kubba A, et al. The benefits of estetrol addition to drospirenone for contraception. AJOG Glob Rep. 2023;3(4):100266. DOI:10.1016/j.xagr.2023.100266
35. Seif MW, Diamond K, Nickkho-Amiry M. Obesity and menstrual disorders. Best Pract Res Clin Obstet Gynaecol. 2015;29(4):516-27. DOI:10.1016/j.bpobgyn.2014.10.010
________________________________________________
2. Abou-Ismail MY, Citla Sridhar D, Nayak L. Estrogen and thrombosis: A bench to bedside review. Thromb Res. 2020;92:40-51. DOI:10.1016/j.thromres.2020.05.008
3. Skeith L, Le Gal G, Rodger MA. Oral contraceptives and hormone replacement therapy: How strong a risk factor for venous thromboembolism? Thromb Res.
2021;202:134-8. DOI:10.1016/j.thromres.2021.03.012
4. Weill A, Dalichampt M, Raguideau F, et al. Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: cohort study. BMJ. 2016;353:i2002. DOI:10.1136/bmj.i2002
5. Allen RH. Combined estrogen-progestin oral contraceptives: Patient selection, counseling and use. Waltham (MA): UpToDate, 2023.
6. Rott H. Birth Control Pills and Thrombotic Risks: Differences of Contraception Methods with and without Estrogen. Hamostaseologie. 2019;39(1):42-8. DOI:10.1055/s-0039-1677806
7. Stocco B, Fumagalli HF, Franceschini SA, et al. Comparative study of the effects of combined oral contraceptives in hemostatic variables: an observational preliminary study. Medicine (Baltimore). 2015;94(4):e385. DOI:10.1097/MD.0000000000000385
8. Dinger J, Do Minh T, Heinemann K. Impact of estrogen type on cardiovascular safety of combined oral contraceptives. Contraception. 2016;94(4):328-39. DOI:10.1016/j.contraception.2016.06.010
9. Stanczyk FZ, Winer SA, Foidart JM, Archer DF. Comparison of estrogenic components used for hormonal contraception. Contraception. 2024;130:110310. DOI:10.1016/j.contraception.2023.110310
10. Douxfils J, Klipping C, Duijkers I, et al. Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters. Contraception. 2020;102(6):396-402. DOI:10.1016/j.contraception.2020.08.015
11. Gérard C, Foidart JM. 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
12. Morimont L, Haguet H, Dogné JM, 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
13. 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(1):135-43. DOI:10.1210/clinem/dgac511
14. Polis CB, Hussain R, Berry A. There might be blood: a scoping review on women’s responses to contraceptive-induced menstrual bleeding changes. Reprod Health. 2018;15(1):114. DOI:10.1186/s12978-018-0561-0
15. Mawet M, Nollevaux F, Nizet D, et al. Impact of a new levonorgestrel intrauterine system, Levosert(®), on heavy menstrual bleeding: results of a one-year randomised controlled trial. Eur J Contracept Reprod Health Care. 2014;19(3):169-79. DOI:10.3109/13625187.2014.894184
16. Rowe P, Farley T, Peregoudov A, et al. Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A. Contraception. 2016;93(6):498-506. DOI:10.1016/j.contraception.2016.02.024
17. Archer DF, Mansour D, Foidart JM. Bleeding Patterns of Oral Contraceptives with a Cyclic Dosing Regimen: An Overview. J Clin Med. 2022;11(15):4634. DOI:10.3390/jcm11154634
18. Critchley HOD, Maybin JA, Armstrong GM, Williams ARW. Physiology of the Endometrium and Regulation of Menstruation. Physiol Rev. 2020;100(3):1149-79. DOI:10.1152/physrev.00031.2019
19. Kuan KKW, Saunders PTK. Female Reproductive Systems: Hormone Dependence and Receptor Expression. Adv Exp Med Biol. 2022;1390:21-39. DOI:10.1007/978-3-031-11836-4_2
20. Burris TP, de Vera IMS, Cote I, et al. International Uni on of Basic and Clinical Pharmacology CXIII: Nuclear Receptor Superfamily-Update 2023. Pharmacol Rev. 2023;75(6):1233-318. DOI:10.1124/pharmrev.121.000436
21. Hirota Y. Progesterone governs endometrial proliferation-differentiation switching and blastocyst implantation. Endocr J. 2019;66(3):199-206. DOI:10.1507/endocrj.EJ18-0431
22. Patel B, Elguero S, Thakore S, et al. Role of nuclear progesterone receptor isoforms in uterine pathophysiology. Hum Reprod Update. 2015;21(2):155-73. DOI:10.1093/humupd/dmu056
23. Dinh A, Sriprasert I, Williams AR, Archer DF. A review of the endometrial histologic effects of progestins and progesterone receptor modulators in reproductive age women. Contraception. 2015;91(5):360-7. DOI:10.1016/j.contraception.2015.01.008
24. Gérard C, Arnal JF, Jost M, et al. Profile of estetrol, a promising native estrogen for oral contraception and the relief of climacteric symptoms of menopause. Expert Rev Clin Pharmacol. 2022;15(2):121-37. DOI:10.1080/17512433.2022.2054413
25. Klipping C, Duijkers I, Mawet M, et al. Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone. Contraception. 2021;103(4):213-21. DOI:10.1016/j.contraception.2021.01.001
26. Inoue K, Barratt A, Richters J. Does research into contraceptive method discontinuation address women’s own reasons? A critical review. J Fam Plann Reprod Health Care. 2015;41(4):292-9. DOI:10.1136/jfprhc-2014-100976
27. 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
28. Gaspard U, Taziaux M, Mawet M, et al. A multicenter, randomized study to sel ect the minimum effective dose of estetrol (E4) in postmenopausal women (E4Relief): part 1. Vasomotor symptoms and overall safety. Menopause. 2020;27(8):848-57. DOI:10.1097/GME.0000000000001561
29. Creinin MD, Westhoff CL, Bouchard C, et al. Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results. Contraception. 2021;104(3):222-8. DOI:10.1016/j.contraception.2021.05.002
30. Gemzell-Danielsson K, Apter D, Zatik J, et al. Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia. BJOG. 2022;129(1):63-71. DOI:10.1111/1471-0528.16840
31. Kaunitz AM, Achilles SL, Zatik J, et al. Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women. Contraception. 2022;116:29-36. DOI:10.1016/j.contraception.2022.07.010
32. Hoffman BL, Schorge JO, Bradshaw KD, et al. Williams Gynecology. 3rd Ed. New York: McGraw-Hill Professional, 2016.
33. Villavicencio J, Allen RH. Unscheduled bleeding and contraceptive choice: increasing satisfaction and continuation rates. Open Access J Contracept. 2016;7:43-52.
34. Foidart JM, Gemzell-Danielsson K, Kubba A, et al. The benefits of estetrol addition to drospirenone for contraception. AJOG Glob Rep. 2023;3(4):100266. DOI:10.1016/j.xagr.2023.100266
35. Seif MW, Diamond K, Nickkho-Amiry M. Obesity and menstrual disorders. Best Pract Res Clin Obstet Gynaecol. 2015;29(4):516-27. DOI:10.1016/j.bpobgyn.2014.10.010
Авторы
И.В. Кузнецова*1, Л.В. Евсюкова2
1ООО «Витбиомед+», Москва, Россия;
2ФГБОУ ВО «Рязанский государственный медицинский университет им. акад. И.П. Павлова» Минздрава России, Рязань, Россия
*ms.smith.ivk@gmail.com
1Vitbiomed+ LLC, Moscow, Russia;
2Pavlov Ryazan State Medical University, Ryazan, Russia
*ms.smith.ivk@gmail.com
1ООО «Витбиомед+», Москва, Россия;
2ФГБОУ ВО «Рязанский государственный медицинский университет им. акад. И.П. Павлова» Минздрава России, Рязань, Россия
*ms.smith.ivk@gmail.com
________________________________________________
1Vitbiomed+ LLC, Moscow, Russia;
2Pavlov Ryazan State Medical University, Ryazan, Russia
*ms.smith.ivk@gmail.com
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.