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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.
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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.