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Сексуальное здоровье женщин, использующих комбинированный оральный контрацептив, содержащий эстетрол и дроспиренон
Сексуальное здоровье женщин, использующих комбинированный оральный контрацептив, содержащий эстетрол и дроспиренон
Оразов М.Р., Радзинский В.Е., Хамошина М.Б., Орехов Р.Е., Ермаков В.В. Сексуальное здоровье женщин, использующих комбинированный оральный контрацептив, содержащий эстетрол и дроспиренон. Гинекология. 2024;26(1):28–34. DOI:10.26442/20795696.2024.1.202568
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
2024;26(1):28–34. DOI:10.26442/20795696.2024.1.202568
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
________________________________________________
2024;26(1):28–34. DOI:10.26442/20795696.2024.1.202568
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
Цель. Оценить влияние комбинированного орального контрацептива (КОК), содержащего эстетрол и дроспиренон, на сексуальную функцию женщин, его использующих.
Материалы и методы. В исследование включили 251 женщину в возрасте 21–35 лет (средний возраст – 25,30±2,82 года), обратившуюся с целью подбора контрацептива (МКБ-10: Z30.0 Общие советы и консультации по контрацепции, Z30.4 Наблюдение за применением противозачаточных лекарственных средств). Женщины изучаемой когорты с целью контрацепции использовали оригинальный препарат, содержащий 15 мг эстетрола и 3 мг дроспиренона, в режиме 24+4 согласно действующей инструкции. У всех участниц (n=251) исследования исходно, через 6 и 12 мес провели оценку сексуальной функции с применением шкал FSFI (The Female Sexual Function Index, Индекс женской сексуальности), FSDS-R (The Female Sexual Distress Scale-Revised, Шкала сексуального дистресса для женщин) и SQoL-F (The Sexual Quality of Life-Female, Качество сексуальной жизни женщин).
Дизайн исследования. Открытое независимое проспективное наблюдательное исследование.
Результаты. У женщин, принимавших КОК, содержащий 15 мг эстетрола и 3 мг дроспиренона, на протяжении всего исследования сохранялся исходно высокий, согласно оценке по шкалам FSFI, SQoL-F и FSDS-R, уровень сексуальной удовлетворенности (p>0,05).
Заключение. Полученные результаты свидетельствуют об отсутствии негативного влияния КОК, содержащего 15 мг эстетрола и 3 мг дроспиренона, на сексуальную функцию женщин. Подтверждена высокая контрацептивная эффективность препарата.
Ключевые слова: КОК, сексуальная функция, эстетрол, дроспиренон
Materials and methods. A total of 251 women aged 21–35 years (mean age, 25.30±2.82 years) referred for contraceptive fitting were included in the study (ICD-10: Z30.0 General contraceptive advice and counseling, Z30.4 Contraceptive drug monitoring). Women in the study cohort used the original formulation containing 15 mg estetrol and 3 mg drospirenone in a 24+4 regimen for contraceptive purposes, according to the current instructions. All female participants (n=251) were assessed for sexual function at baseline, 6 and 12 months using FSFI (The Female Sexual Function Index), FSDS-R (The Female Sexual Distress Scale-Revised) and SQoL-F (The Sexual Quality of Life-Female) scales.
Study design. An open, independent, prospective observational study.
Results. Women taking COC containing estetrol 15 mg and drospirenone 3 mg maintained a baseline high level of sexual satisfaction (p>0.05) throughout the study, as assessed by FSFI, SQoL-F and FSDS-R scales.
Conclusion. The results obtained indicate that there is no negative effect of COC containing 15 mg estetrol and 3 mg drospirenonone on the sexual function of women. High contraceptive efficacy of the drug was confirmed.
Keywords: COCs, sexual function, estetrol, drosperinone
Материалы и методы. В исследование включили 251 женщину в возрасте 21–35 лет (средний возраст – 25,30±2,82 года), обратившуюся с целью подбора контрацептива (МКБ-10: Z30.0 Общие советы и консультации по контрацепции, Z30.4 Наблюдение за применением противозачаточных лекарственных средств). Женщины изучаемой когорты с целью контрацепции использовали оригинальный препарат, содержащий 15 мг эстетрола и 3 мг дроспиренона, в режиме 24+4 согласно действующей инструкции. У всех участниц (n=251) исследования исходно, через 6 и 12 мес провели оценку сексуальной функции с применением шкал FSFI (The Female Sexual Function Index, Индекс женской сексуальности), FSDS-R (The Female Sexual Distress Scale-Revised, Шкала сексуального дистресса для женщин) и SQoL-F (The Sexual Quality of Life-Female, Качество сексуальной жизни женщин).
Дизайн исследования. Открытое независимое проспективное наблюдательное исследование.
Результаты. У женщин, принимавших КОК, содержащий 15 мг эстетрола и 3 мг дроспиренона, на протяжении всего исследования сохранялся исходно высокий, согласно оценке по шкалам FSFI, SQoL-F и FSDS-R, уровень сексуальной удовлетворенности (p>0,05).
Заключение. Полученные результаты свидетельствуют об отсутствии негативного влияния КОК, содержащего 15 мг эстетрола и 3 мг дроспиренона, на сексуальную функцию женщин. Подтверждена высокая контрацептивная эффективность препарата.
Ключевые слова: КОК, сексуальная функция, эстетрол, дроспиренон
________________________________________________
Materials and methods. A total of 251 women aged 21–35 years (mean age, 25.30±2.82 years) referred for contraceptive fitting were included in the study (ICD-10: Z30.0 General contraceptive advice and counseling, Z30.4 Contraceptive drug monitoring). Women in the study cohort used the original formulation containing 15 mg estetrol and 3 mg drospirenone in a 24+4 regimen for contraceptive purposes, according to the current instructions. All female participants (n=251) were assessed for sexual function at baseline, 6 and 12 months using FSFI (The Female Sexual Function Index), FSDS-R (The Female Sexual Distress Scale-Revised) and SQoL-F (The Sexual Quality of Life-Female) scales.
Study design. An open, independent, prospective observational study.
Results. Women taking COC containing estetrol 15 mg and drospirenone 3 mg maintained a baseline high level of sexual satisfaction (p>0.05) throughout the study, as assessed by FSFI, SQoL-F and FSDS-R scales.
Conclusion. The results obtained indicate that there is no negative effect of COC containing 15 mg estetrol and 3 mg drospirenonone on the sexual function of women. High contraceptive efficacy of the drug was confirmed.
Keywords: COCs, sexual function, estetrol, drosperinone
Полный текст
Список литературы
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20. Beyhaghi H, Reeve BB, Rodgers JE, Stearns SC. Psychometric Properties of the Four-Item Morisky Green Levine Medication Adherence Scale among Atherosclerosis Risk in Communities (ARIC) Study Participants. Value Health. 2016;19(8):996-1001. DOI:10.1016/j.jval.2016.07.001
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24. Pastor Z, Holla K, Chmel R. The influence of combined oral contraceptives on female sexual desire: A systematic review. Eur J Contracept Reprod Health Care. 2013;18(1):27-43. DOI:10.3109/13625187.2012.728643
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27. Skovlund CW, Mørch LS, Kessing LV, Lidegaard Ø. Association of Hormonal Contraception With Depression. JAMA Psychiatry. 2016;73(11):1154-62. DOI:10.1001/jamapsychiatry.2016.2387. Erratum in: JAMA Psychiatry. 2017;74(7):764.
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. Singer CF, Bennink HJ, Natter C, et al. Antiestrogenic effects of the fetal estrogen estetrol in women with estrogen-receptor positive early breast cancer. Carcinogenesis. 2014;35(11):2447-51. DOI:10.1093/carcin/bgu144
30. Duijkers IJ, Klipping C, Zimmerman Y, et al. Inhibition of ovulation by administration of estetrol in combination with drospirenone or levonorgestrel: results of a phase II dose-finding pilot study. Eur J Contracept Reprod Health Care. 2015;20(6):476-89. DOI:10.3109/13625187.2015.1074675
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2. Chaplin S. Drovelis: an oral contraceptive with drospirenone and estetrol. Prescriber. 2023;34:31-2. DOI:10.1002/psb.2057
3. Gerard C, La Riche A, Altendorf S, et al. FRI378 Estetrol Prolongs Anagen In Healthy Female Scalp Hair Follicles By Positively Modulating Dermal Papilla Functions And Generation Of Progenitor Stem Cells Ex Vivo. Journal of the Endocrine Society. 2023;7(Suppl. 1):bvad114.1574. DOI:10.1210/jendso/bvad114.1574
4. Gérard C, Apter D, Chatel G, et al. RF34 | PMON202 The Human Metabolic Profile of Estetrol. J Endocr Soc. 2022;6(Suppl. 1):A714-5. DOI:10.1210/jendso/bvac150.1472
5. Holinka CF, Diczfalusy E, Coelingh Bennink HJ. 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
6. Apter D, Zimmerman Y, Beekman L, et al. Estetrol combined with drospirenone: an oral contraceptive with high acceptability, user satisfaction, well-being and favourable body weight control. Eur J Contracept Reprod Health Care. 2017;22(4):260-7. DOI:10.1080/13625187.2017.1336532
7. Apter D, Zimmerman Y, Beekman L, et al. Bleeding pattern and cycle control with estetrol-containing combined oral contraceptives: results from a phase II, randomised, dose-finding study (FIESTA). Contraception. 2016;94(4):366-73. DOI:10.1016/j.contraception.2016.04.015
8. 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
9. Sanders SA, Graham CA, Bass JL, Bancroft J. A prospective study of the effects of oral contraceptives on sexuality and well-being and their relationship to discontinuation. Contraception. 2001;64(1):51-8. DOI:10.1016/s0010-7824(01)00218-9
10. Casado-Espada NM, de Alarcón R, de la Iglesia-Larrad, JI, et al. Hormonal contraceptives, female sexual dysfunction, and managing strategies: A review. J Clin Med. 2019;8(6):908. DOI:10.3390/jcm8060908
11. Harlow SD, Gass M, Hall JE, et al; STRAW+10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop +10: addressing the unfinished agenda of staging reproductive aging. Climacteric. 2012;15(2):105-14. DOI:10.3109/13697137.2011.650656
12. Walter S, Upadhjay M, Beslic J, et al. FSFI score and timing of tubal ligation in patients: preliminary results of an online survey. Arch Gynecol Obstet. 2022;306(3):795-800. DOI:10.1007/s00404-022-06547-8
13. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191-208. DOI:10.1080/009262300278597
14. Sand M, Rosen R, Meston C, Brotto LA. The female sexual function index (FSFI): a potential «gold standard» measure for assessing therapeutically-induced change in female sexual function. Fertility and Sterility. 2009;92(Suppl. 3):S129. DOI:10.1016/j.fertnstert.2009.07.1173
15. Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31(1):1-20. DOI:10.1080/00926230590475206
16. Carpenter JS, Reed SD, Guthrie KA, et al. Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis. Sex Med. 2015;3(1):7-13. DOI:10.1002/sm2.53
17. Derogatis L, Clayton A, Lewis-D'Agostino D, et al. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008;5(2):357-64. DOI:10.1111/j.1743-6109.2007.00672.x
18. Maasoumi R, Lamyian M, Montazeri A, et al. The sexual quality of life-female (SQoL-F) questionnaire: translation and psychometric properties of the Iranian version. Reprod Health. 2013;10:25. DOI:10.1186/1742-4755-10-25
19. Sim-Sim M, Aaberg V, Gómez-Cantarino S, et al. Sexual Quality of Life-Female (SQoL-F): Cultural Adaptation and Validation of European Portuguese Version. Healthcare (Basel). 2022;10(2):255. DOI:10.3390/healthcare10020255
20. Beyhaghi H, Reeve BB, Rodgers JE, Stearns SC. Psychometric Properties of the Four-Item Morisky Green Levine Medication Adherence Scale among Atherosclerosis Risk in Communities (ARIC) Study Participants. Value Health. 2016;19(8):996-1001. DOI:10.1016/j.jval.2016.07.001
21. Ob utverzhdenii Poriadka okazaniia meditsinskoi pomoshchi po profiliu «Akusherstvo i ginekologiia». Prikaz Minzdrava Rossii ot 20.10.2020 №1130n (in Russian).
22. Bitzer J. Pharmacological profile of estrogens in oral contraception. Minerva Ginecol. 2011;63(3):299-304.
23. Davis SR, Bitzer J, Giraldi A, et al. Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. J Sex Med. 2013;10(12):3069-79. DOI:10.1111/jsm.12310
24. Pastor Z, Holla K, Chmel R. The influence of combined oral contraceptives on female sexual desire: A systematic review. Eur J Contracept Reprod Health Care. 2013;18(1):27-43. DOI:10.3109/13625187.2012.728643
25. Burrows LJ, Basha M, Goldstein AT. The effects of hormonal contraceptives on female sexuality: a review. J Sex Med. 2012;9(9):2213-23. DOI:10.1111/j.1743-6109.2012.02848.x
26. Zethraeus N, Dreber A, Ranehill E, et al. A first-choice combined oral contraceptive influences general well-being in healthy women: a double-blind, randomized, placebo-controlled trial. Fertil Steril. 2017;107(5):1238-45.
27. Skovlund CW, Mørch LS, Kessing LV, Lidegaard Ø. Association of Hormonal Contraception With Depression. JAMA Psychiatry. 2016;73(11):1154-62. DOI:10.1001/jamapsychiatry.2016.2387. Erratum in: JAMA Psychiatry. 2017;74(7):764.
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. Singer CF, Bennink HJ, Natter C, et al. Antiestrogenic effects of the fetal estrogen estetrol in women with estrogen-receptor positive early breast cancer. Carcinogenesis. 2014;35(11):2447-51. DOI:10.1093/carcin/bgu144
30. Duijkers IJ, Klipping C, Zimmerman Y, et al. Inhibition of ovulation by administration of estetrol in combination with drospirenone or levonorgestrel: results of a phase II dose-finding pilot study. Eur J Contracept Reprod Health Care. 2015;20(6):476-89. DOI:10.3109/13625187.2015.1074675
31. Coelingh Bennink HJT, Verhoeven C, Zimmerman Y, et al. Pharmacodynamic effects of the fetal estrogen estetrol in postmenopausal women: results fr om a multiple-rising-dose study. Menopause. 2017;24(6):677-85. DOI:10.1097/GME.0000000000000823
32. 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.
33. Kluft C, Zimmerman Y, Mawet M, et al. Reduced haemostatic 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
34. Jockenhövel F. Testosterone therapy – what, when and to whom? Aging Male. 2004;7(4):319-24. DOI:10.1080/13685530400016557
35. EudraCT 2016-004267-40. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004267-40/results. Accessed: 24.11.2020.
36. E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) – EU/Russia Study. ClinicalTrials.gov ID: NCT02817828. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02817828?term=estetrol&phase=2&draw=2&rank=3. Accessed: 24.11.2020.
37. E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) – United States/Canada Study. ClinicalTrials.gov ID: NCT02817841. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02817841?term=estetrol&phase=2&draw=2&rank=4. Accessed: 24.11.2020.
38. 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
39. Hammond GL, Hogeveen KN, Visser M, Coelingh Bennink HJT. Estetrol does not bind sex hormone binding globulin or increase its production by human HepG2 cells. Climacteric. 2008;11(Suppl. 1):41-6. DOI:10.1080/13697130701851814
40. 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
2. Chaplin S. Drovelis: an oral contraceptive with drospirenone and estetrol. Prescriber. 2023;34:31-2. DOI:10.1002/psb.2057
3. Gerard C, La Riche A, Altendorf S, et al. FRI378 Estetrol Prolongs Anagen In Healthy Female Scalp Hair Follicles By Positively Modulating Dermal Papilla Functions And Generation Of Progenitor Stem Cells Ex Vivo. Journal of the Endocrine Society. 2023;7(Suppl. 1):bvad114.1574. DOI:10.1210/jendso/bvad114.1574
4. Gérard C, Apter D, Chatel G, et al. RF34 | PMON202 The Human Metabolic Profile of Estetrol. J Endocr Soc. 2022;6(Suppl. 1):A714-5. DOI:10.1210/jendso/bvac150.1472
5. Holinka CF, Diczfalusy E, Coelingh Bennink HJ. 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
6. Apter D, Zimmerman Y, Beekman L, et al. Estetrol combined with drospirenone: an oral contraceptive with high acceptability, user satisfaction, well-being and favourable body weight control. Eur J Contracept Reprod Health Care. 2017;22(4):260-7. DOI:10.1080/13625187.2017.1336532
7. Apter D, Zimmerman Y, Beekman L, et al. Bleeding pattern and cycle control with estetrol-containing combined oral contraceptives: results from a phase II, randomised, dose-finding study (FIESTA). Contraception. 2016;94(4):366-73. DOI:10.1016/j.contraception.2016.04.015
8. 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
9. Sanders SA, Graham CA, Bass JL, Bancroft J. A prospective study of the effects of oral contraceptives on sexuality and well-being and their relationship to discontinuation. Contraception. 2001;64(1):51-8. DOI:10.1016/s0010-7824(01)00218-9
10. Casado-Espada NM, de Alarcón R, de la Iglesia-Larrad, JI, et al. Hormonal contraceptives, female sexual dysfunction, and managing strategies: A review. J Clin Med. 2019;8(6):908. DOI:10.3390/jcm8060908
11. Harlow SD, Gass M, Hall JE, et al; STRAW+10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop +10: addressing the unfinished agenda of staging reproductive aging. Climacteric. 2012;15(2):105-14. DOI:10.3109/13697137.2011.650656
12. Walter S, Upadhjay M, Beslic J, et al. FSFI score and timing of tubal ligation in patients: preliminary results of an online survey. Arch Gynecol Obstet. 2022;306(3):795-800. DOI:10.1007/s00404-022-06547-8
13. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191-208. DOI:10.1080/009262300278597
14. Sand M, Rosen R, Meston C, Brotto LA. The female sexual function index (FSFI): a potential «gold standard» measure for assessing therapeutically-induced change in female sexual function. Fertility and Sterility. 2009;92(Suppl. 3):S129. DOI:10.1016/j.fertnstert.2009.07.1173
15. Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31(1):1-20. DOI:10.1080/00926230590475206
16. Carpenter JS, Reed SD, Guthrie KA, et al. Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis. Sex Med. 2015;3(1):7-13. DOI:10.1002/sm2.53
17. Derogatis L, Clayton A, Lewis-D'Agostino D, et al. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008;5(2):357-64. DOI:10.1111/j.1743-6109.2007.00672.x
18. Maasoumi R, Lamyian M, Montazeri A, et al. The sexual quality of life-female (SQoL-F) questionnaire: translation and psychometric properties of the Iranian version. Reprod Health. 2013;10:25. DOI:10.1186/1742-4755-10-25
19. Sim-Sim M, Aaberg V, Gómez-Cantarino S, et al. Sexual Quality of Life-Female (SQoL-F): Cultural Adaptation and Validation of European Portuguese Version. Healthcare (Basel). 2022;10(2):255. DOI:10.3390/healthcare10020255
20. Beyhaghi H, Reeve BB, Rodgers JE, Stearns SC. Psychometric Properties of the Four-Item Morisky Green Levine Medication Adherence Scale among Atherosclerosis Risk in Communities (ARIC) Study Participants. Value Health. 2016;19(8):996-1001. DOI:10.1016/j.jval.2016.07.001
21. Об утверждении Порядка оказания медицинской помощи по профилю «Акушерство и гинекология». Приказ Минздрава России от 20.10.2020 №1130н [Ob utverzhdenii Poriadka okazaniia meditsinskoi pomoshchi po profiliu «Akusherstvo i ginekologiia». Prikaz Minzdrava Rossii ot 20.10.2020 №1130n (in Russian)].
22. Bitzer J. Pharmacological profile of estrogens in oral contraception. Minerva Ginecol. 2011;63(3):299-304.
23. Davis SR, Bitzer J, Giraldi A, et al. Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. J Sex Med. 2013;10(12):3069-79. DOI:10.1111/jsm.12310
24. Pastor Z, Holla K, Chmel R. The influence of combined oral contraceptives on female sexual desire: A systematic review. Eur J Contracept Reprod Health Care. 2013;18(1):27-43. DOI:10.3109/13625187.2012.728643
25. Burrows LJ, Basha M, Goldstein AT. The effects of hormonal contraceptives on female sexuality: a review. J Sex Med. 2012;9(9):2213-23. DOI:10.1111/j.1743-6109.2012.02848.x
26. Zethraeus N, Dreber A, Ranehill E, et al. A first-choice combined oral contraceptive influences general well-being in healthy women: a double-blind, randomized, placebo-controlled trial. Fertil Steril. 2017;107(5):1238-45.
27. Skovlund CW, Mørch LS, Kessing LV, Lidegaard Ø. Association of Hormonal Contraception With Depression. JAMA Psychiatry. 2016;73(11):1154-62. DOI:10.1001/jamapsychiatry.2016.2387. Erratum in: JAMA Psychiatry. 2017;74(7):764.
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. Singer CF, Bennink HJ, Natter C, et al. Antiestrogenic effects of the fetal estrogen estetrol in women with estrogen-receptor positive early breast cancer. Carcinogenesis. 2014;35(11):2447-51. DOI:10.1093/carcin/bgu144
30. Duijkers IJ, Klipping C, Zimmerman Y, et al. Inhibition of ovulation by administration of estetrol in combination with drospirenone or levonorgestrel: results of a phase II dose-finding pilot study. Eur J Contracept Reprod Health Care. 2015;20(6):476-89. DOI:10.3109/13625187.2015.1074675
31. Coelingh Bennink HJT, Verhoeven C, Zimmerman Y, et al. Pharmacodynamic effects of the fetal estrogen estetrol in postmenopausal women: results fr om a multiple-rising-dose study. Menopause. 2017;24(6):677-85. DOI:10.1097/GME.0000000000000823
32. 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.
33. Kluft C, Zimmerman Y, Mawet M, et al. Reduced haemostatic 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
34. Jockenhövel F. Testosterone therapy – what, when and to whom? Aging Male. 2004;7(4):319-24. DOI:10.1080/13685530400016557
35. EudraCT 2016-004267-40. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004267-40/results. Accessed: 24.11.2020.
36. E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) – EU/Russia Study. ClinicalTrials.gov ID: NCT02817828. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02817828?term=estetrol&phase=2&draw=2&rank=3. Accessed: 24.11.2020.
37. E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) – United States/Canada Study. ClinicalTrials.gov ID: NCT02817841. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02817841?term=estetrol&phase=2&draw=2&rank=4. Accessed: 24.11.2020.
38. 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
39. Hammond GL, Hogeveen KN, Visser M, Coelingh Bennink HJT. Estetrol does not bind sex hormone binding globulin or increase its production by human HepG2 cells. Climacteric. 2008;11(Suppl. 1):41-6. DOI:10.1080/13697130701851814
40. 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
________________________________________________
2. Chaplin S. Drovelis: an oral contraceptive with drospirenone and estetrol. Prescriber. 2023;34:31-2. DOI:10.1002/psb.2057
3. Gerard C, La Riche A, Altendorf S, et al. FRI378 Estetrol Prolongs Anagen In Healthy Female Scalp Hair Follicles By Positively Modulating Dermal Papilla Functions And Generation Of Progenitor Stem Cells Ex Vivo. Journal of the Endocrine Society. 2023;7(Suppl. 1):bvad114.1574. DOI:10.1210/jendso/bvad114.1574
4. Gérard C, Apter D, Chatel G, et al. RF34 | PMON202 The Human Metabolic Profile of Estetrol. J Endocr Soc. 2022;6(Suppl. 1):A714-5. DOI:10.1210/jendso/bvac150.1472
5. Holinka CF, Diczfalusy E, Coelingh Bennink HJ. 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
6. Apter D, Zimmerman Y, Beekman L, et al. Estetrol combined with drospirenone: an oral contraceptive with high acceptability, user satisfaction, well-being and favourable body weight control. Eur J Contracept Reprod Health Care. 2017;22(4):260-7. DOI:10.1080/13625187.2017.1336532
7. Apter D, Zimmerman Y, Beekman L, et al. Bleeding pattern and cycle control with estetrol-containing combined oral contraceptives: results from a phase II, randomised, dose-finding study (FIESTA). Contraception. 2016;94(4):366-73. DOI:10.1016/j.contraception.2016.04.015
8. 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
9. Sanders SA, Graham CA, Bass JL, Bancroft J. A prospective study of the effects of oral contraceptives on sexuality and well-being and their relationship to discontinuation. Contraception. 2001;64(1):51-8. DOI:10.1016/s0010-7824(01)00218-9
10. Casado-Espada NM, de Alarcón R, de la Iglesia-Larrad, JI, et al. Hormonal contraceptives, female sexual dysfunction, and managing strategies: A review. J Clin Med. 2019;8(6):908. DOI:10.3390/jcm8060908
11. Harlow SD, Gass M, Hall JE, et al; STRAW+10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop +10: addressing the unfinished agenda of staging reproductive aging. Climacteric. 2012;15(2):105-14. DOI:10.3109/13697137.2011.650656
12. Walter S, Upadhjay M, Beslic J, et al. FSFI score and timing of tubal ligation in patients: preliminary results of an online survey. Arch Gynecol Obstet. 2022;306(3):795-800. DOI:10.1007/s00404-022-06547-8
13. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191-208. DOI:10.1080/009262300278597
14. Sand M, Rosen R, Meston C, Brotto LA. The female sexual function index (FSFI): a potential «gold standard» measure for assessing therapeutically-induced change in female sexual function. Fertility and Sterility. 2009;92(Suppl. 3):S129. DOI:10.1016/j.fertnstert.2009.07.1173
15. Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31(1):1-20. DOI:10.1080/00926230590475206
16. Carpenter JS, Reed SD, Guthrie KA, et al. Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis. Sex Med. 2015;3(1):7-13. DOI:10.1002/sm2.53
17. Derogatis L, Clayton A, Lewis-D'Agostino D, et al. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008;5(2):357-64. DOI:10.1111/j.1743-6109.2007.00672.x
18. Maasoumi R, Lamyian M, Montazeri A, et al. The sexual quality of life-female (SQoL-F) questionnaire: translation and psychometric properties of the Iranian version. Reprod Health. 2013;10:25. DOI:10.1186/1742-4755-10-25
19. Sim-Sim M, Aaberg V, Gómez-Cantarino S, et al. Sexual Quality of Life-Female (SQoL-F): Cultural Adaptation and Validation of European Portuguese Version. Healthcare (Basel). 2022;10(2):255. DOI:10.3390/healthcare10020255
20. Beyhaghi H, Reeve BB, Rodgers JE, Stearns SC. Psychometric Properties of the Four-Item Morisky Green Levine Medication Adherence Scale among Atherosclerosis Risk in Communities (ARIC) Study Participants. Value Health. 2016;19(8):996-1001. DOI:10.1016/j.jval.2016.07.001
21. Ob utverzhdenii Poriadka okazaniia meditsinskoi pomoshchi po profiliu «Akusherstvo i ginekologiia». Prikaz Minzdrava Rossii ot 20.10.2020 №1130n (in Russian).
22. Bitzer J. Pharmacological profile of estrogens in oral contraception. Minerva Ginecol. 2011;63(3):299-304.
23. Davis SR, Bitzer J, Giraldi A, et al. Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. J Sex Med. 2013;10(12):3069-79. DOI:10.1111/jsm.12310
24. Pastor Z, Holla K, Chmel R. The influence of combined oral contraceptives on female sexual desire: A systematic review. Eur J Contracept Reprod Health Care. 2013;18(1):27-43. DOI:10.3109/13625187.2012.728643
25. Burrows LJ, Basha M, Goldstein AT. The effects of hormonal contraceptives on female sexuality: a review. J Sex Med. 2012;9(9):2213-23. DOI:10.1111/j.1743-6109.2012.02848.x
26. Zethraeus N, Dreber A, Ranehill E, et al. A first-choice combined oral contraceptive influences general well-being in healthy women: a double-blind, randomized, placebo-controlled trial. Fertil Steril. 2017;107(5):1238-45.
27. Skovlund CW, Mørch LS, Kessing LV, Lidegaard Ø. Association of Hormonal Contraception With Depression. JAMA Psychiatry. 2016;73(11):1154-62. DOI:10.1001/jamapsychiatry.2016.2387. Erratum in: JAMA Psychiatry. 2017;74(7):764.
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. Singer CF, Bennink HJ, Natter C, et al. Antiestrogenic effects of the fetal estrogen estetrol in women with estrogen-receptor positive early breast cancer. Carcinogenesis. 2014;35(11):2447-51. DOI:10.1093/carcin/bgu144
30. Duijkers IJ, Klipping C, Zimmerman Y, et al. Inhibition of ovulation by administration of estetrol in combination with drospirenone or levonorgestrel: results of a phase II dose-finding pilot study. Eur J Contracept Reprod Health Care. 2015;20(6):476-89. DOI:10.3109/13625187.2015.1074675
31. Coelingh Bennink HJT, Verhoeven C, Zimmerman Y, et al. Pharmacodynamic effects of the fetal estrogen estetrol in postmenopausal women: results fr om a multiple-rising-dose study. Menopause. 2017;24(6):677-85. DOI:10.1097/GME.0000000000000823
32. 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.
33. Kluft C, Zimmerman Y, Mawet M, et al. Reduced haemostatic 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
34. Jockenhövel F. Testosterone therapy – what, when and to whom? Aging Male. 2004;7(4):319-24. DOI:10.1080/13685530400016557
35. EudraCT 2016-004267-40. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004267-40/results. Accessed: 24.11.2020.
36. E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) – EU/Russia Study. ClinicalTrials.gov ID: NCT02817828. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02817828?term=estetrol&phase=2&draw=2&rank=3. Accessed: 24.11.2020.
37. E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) – United States/Canada Study. ClinicalTrials.gov ID: NCT02817841. Available at: https://www.clinicaltrials.gov/ct2/show/NCT02817841?term=estetrol&phase=2&draw=2&rank=4. Accessed: 24.11.2020.
38. 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
39. Hammond GL, Hogeveen KN, Visser M, Coelingh Bennink HJT. Estetrol does not bind sex hormone binding globulin or increase its production by human HepG2 cells. Climacteric. 2008;11(Suppl. 1):41-6. DOI:10.1080/13697130701851814
40. 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
Авторы
М.Р. Оразов*, В.Е. Радзинский, М.Б. Хамошина, Р.Е. Орехов, В.В. Ермаков
ФГАОУ ВО «Российский университет дружбы народов», Москва, Россия
*omekan@mail.ru
People’s Friendship University of Russia (RUDN University), Moscow, Russia
*omekan@mail.ru
ФГАОУ ВО «Российский университет дружбы народов», Москва, Россия
*omekan@mail.ru
________________________________________________
People’s Friendship University of Russia (RUDN University), Moscow, Russia
*omekan@mail.ru
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