Комбинированные оральные контрацептивы, содержащие хлормадинона ацетат в качестве гестагенного компонента, кроме противозачаточного эффекта обеспечивают стабильность менструального цикла при гиперполименорее и дисменорее, а также оказывают выраженное лечебное воздействие при андрогензависимых дерматопатиях и проявлениях предменструального синдрома.
Сontraceptives containing chlormadinone acetate as the progestin component other than a contraceptive effect, ensure the stability of the menstrual cycle when giperpolimenoree and dysmenorrhea, and also have a pronounced therapeutic effect in androgen-dependent dermatopatiyah and manifestations of premenstrual syndrome.
1. Бороян Р.Г. Клиническая фармакология для акушеров-гинекологов. М.: Практическая медицина, 2008.
2. Вихляева Е.М. Руководство по эндокринной гинекологии. М.: МИА, 2006.
3. Прилепская В.Н., Межевитинова Е.А., Назарова Н.М., Бостанджян Л.Л. Гормональная контрацепция. М.: ГЭОТАР-Медиа, 2011.
4. Белоусов Ю.Б., Кукес В.Г., Лепахин В.К., Петров В.И. Клиническая фармакология. Национальное руководство. М.: ГЭОТАР-Медиа, 2012.
5. Машковский М.Д. Лекарственные средства.16-е изд., перераб., испр. и доп. М.: Новая волна, 2010.
6. Клозер Я., Бартоломойс И., Вильсманн К., Шрам Г. Применение комбинации из этинилэстрадиола и ацетата хлормадинона для приготовления лекарственного средства. Патент на изобретение, 2005.
7. Сметник В.П. Эстрогены. М.: Практическая медицина, 2012.
8. Справочник ВИДАЛЬ-2012. 18-е изд., перераб., испр. и доп. М.: АстраФармСервис, 2012.
9. Contreras CM, Azamar-Arizmendi G, Saavedra M, Hernández-Lozano M. A five-day gradual reduction regimen of chlormadinone reduces premenstrual anxiety and depression: a pilot study. Arch Med Res 2006; 37 (7): 907–13.
10. Anthuber S, Schramm GA, Heskamp ML. Six-month evaluation of the benefits of the low-dose combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg in young women: results of the prospective, observational, non-interventional, multicentre TeeNIS study. Clin Drugs Investig 2010; 30 (4): 211–20.
11. Bitzer J. Belara – proven benefits in daily practice. Eur J Contracept Reprod Health Care 2005; 10 (Suppl. 1): 19–25.
12. Caruso S, Rugolo S, Agnello C et al. Quality of sexual life in hyperandrogenic women treated with an oral contraceptive containing chlormadinone acetate. J Sex Med 2009; 6 (12): 3376–84.
13. De LeoV, di Sabatino A, Musacchio MC et al. Effect of oral contraceptives on markers of hyperandrogenism and SHBG in women with polycystic ovary syndrome. Contraception 2010; 82 (3): 276–80.
14. Kerscher M, Reuther T, Bayrhammer J, Schramm G. Effects of an oral contraceptive containing chlormadinone and ethinylestradiol on acne-prone skin of women of different age groups: an open-label, single-centre, phase IV study. Clin Drugs Investig 2008; 28 (11): 703–11.
15. Lello S, Primavera G, Colonna L et al. Effects of two estroprogestins containing ethynilestradiol 30 microg and drospirenone 3 mg and ethynilestradiol 30 microg and chlormadinone 2 mg on skin and hormonal hyperandrogenic manifestations. Gynecol Endocrinol 2008; 24 (12): 718–23.
16. Plewig G, Cunliffe WJ, Binder N, Höschen K. Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial. Contraception 2009; 80 (1): 25–33.
17. Uras R, Orrù M, Pani F et al. Endocrinological, metabolic and clinical features of treatment with oral contraceptive formulation containing ethinylestradiol plus chlormadinone acetate in nonobese women with polycystic ovary syndrome. Contraception 2010; 82 (2): 131–8.
18. Rabe T, Hartschuh E, Wahlstrom T et al. Endometrial safety of a novel monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen over six cycles. Contraception 2010; 82 (4): 358–65.
19. Guido M, Romualdi D, Campagna G et al. Ethinylestradiol-chlormadinone acetate combination for the treatment of hirsutism and hormonal alterations of normal-weight women with polycystic ovary syndrome: evaluation of the metabolic impact. Reprod Sci 2010; 17 (8): 767–75.
20. Gómez M Vázquez, Navarra Amayuelas R, Lamarca M et al. Ethinylestradiol/Chlormadinone acetate for use in dermatological disorders. Am J Clin Dermatol (Suppl. 1) 2011; 6 (12): 13–9.
21. Uras R, Orrù M, Etzi R et al. Evidence that in healthy young women, a six-cycle treatment with oral contraceptive containing 30 mcg of ethinylestradiol plus 2 mg of chlormadinone acetate reduces fat mass. Contraception 2009; 79 (2): 117–21.
22. Göretzlehner G, Waldmann-Rex S, Schramm GA. Extended cycles with the combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg: pooled analysis of data from three large-scale, non-interventional, observational studies. Clin Drug Investig 2011; 31 (4): 269–77.
23. Huber JC, Heskamp ML, Schramm GA. Effect of an oral contraceptive with chlormadinone acetate on depressive mood: analysis of data from four observational studies. Clin Drugs Investig 2008; 28 (12): 783–91.
24. Alhenc-Gelas M, Plu-Bureau G, Guillonneau S et al. Impact of progestagens on activated protein C (APC) resistance among users of oral contraceptives. Thromb Haemost 2004; 2 (9): 1594–600.
25. Cagnacci A, Ferrari S, Tirelli A et al. Insulin sensitivity and lipid metabolism with oral contraceptives containing chlormadinone acetate or desogestrel: a randomized trial. Contraception 2009; 79 (2): 111–6.
26. Brucker C, Hedon B et al. Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen. Contraception 2010; 81 (6): 501–9.
27. Meier CR. Health risks of oral contraceptive. Ther Umsch 2011; 68 (6): 345–52.
28. Terlinden R, Uragg H, Göhler K, Kneip C. Pharmacokinetics of chlormadinone acetate following single and multiple oral dosing of chlormadinone acetate (2 mg) and ethinylestradiol (0.03 mg) and elimination and clearance of a single dose of radiolabeled chlormadinone acetate. Contraception 2006; 74 (3): 239–44.
29. Chabbert-Buffet N, Amoura Z, Scarabin PY et al. Pregnane progestin contraception in systemic lupus erythematosus: a longitudinal study of 187 patients. Contraception 2011; 83 (3): 229–37.
30. Conard J, Plu-Bureau G, Bahi N et al. Progestogen-only contraception in women at high risk of venous thromboembolism. Contraception 2004; 70 (6): 437–41.
31. Rosendaal F, Helmerhorst Vandenbrouke F. Female hormones and thrombosis. J Arterioscler Thromb Vascul Biol 2002; 22: 201–10.
32. Pushparajah DS, Röhm P, Höschen K et al. Safety data and beneficial effects of the combined oral contraceptive ethinylestradiol 0.03 mg/chlormadinone acetate 2 mg (Belara®): a 13-cycle, observational study in routine clinical practice. Clin Drug Investig 2011; 31 (20): 121–34.
33. Schramm G, Steffens D. A 12-month evaluation of the CMA-containing oral contraceptive Belara: efficacy, tolerability and anti-androgenic properties. Contraception 2003; 67 (4): 305–12.
34. Schramm G, Heckes B. Switching hormonal contraceptives to a chlormadinone acetate-containing oral contraceptive – the Contraceptive Switch Study. Contraception 2007; 76 (2): 84–90.
35. Schramm GA, Schrah G. The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adult and adolescent women. Contraception 2011; 84 (4): 390–401.
36. Spona J, Binder N, Höschen K, Feichtinger W. Suppression of ovarian function by a combined oral contraceptive containing 0.02 mg ethinyl estradiol and 2 mg chlormadinone acetate given in a 24/4-day intake regimen over three cycles. Fertil Steril 2010; 94 (4): 1195–201.
37. Bitzer J, Frey B, von Schönau M et al. Twenty or thirty microgram ethinyloestradiol in an oral contraceptive: does it make a difference in the mind and the daily practise of gynaecologists and general practitioners? Eur J Contracept Reprod Health Care 2009; 14 (4): 258–67.
38. Winkler UH, Sudik R. The effects of two monophasic oral contraceptives containing 30 mcg of ethinylestradiol and either 2 mg of chlormadinone acetate or 0.15 mg of desogestrel on lipid, hormone and metabolic parameters. Contraception 2009; 79 (1): 15–23.
39. Winkler UH, Röhm P, Höschen K. An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables. Contraception 2010; 81 (5): 391–400.
40. Zahradnik HP, Hanjalic-Beck A. Efficacy, safety and sustainability of treatment continuation and results of an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg chlormadinone acetate, in long-term usage (up to 45 cycles) – an open-label, prospective, noncontrolled, office-based Phase III study. Contraception 2008; 77 (5): 337–43.
________________________________________________
1. Бороян Р.Г. Клиническая фармакология для акушеров-гинекологов. М.: Практическая медицина, 2008.
2. Вихляева Е.М. Руководство по эндокринной гинекологии. М.: МИА, 2006.
3. Прилепская В.Н., Межевитинова Е.А., Назарова Н.М., Бостанджян Л.Л. Гормональная контрацепция. М.: ГЭОТАР-Медиа, 2011.
4. Белоусов Ю.Б., Кукес В.Г., Лепахин В.К., Петров В.И. Клиническая фармакология. Национальное руководство. М.: ГЭОТАР-Медиа, 2012.
5. Машковский М.Д. Лекарственные средства.16-е изд., перераб., испр. и доп. М.: Новая волна, 2010.
6. Клозер Я., Бартоломойс И., Вильсманн К., Шрам Г. Применение комбинации из этинилэстрадиола и ацетата хлормадинона для приготовления лекарственного средства. Патент на изобретение, 2005.
7. Сметник В.П. Эстрогены. М.: Практическая медицина, 2012.
8. Справочник ВИДАЛЬ-2012. 18-е изд., перераб., испр. и доп. М.: АстраФармСервис, 2012.
9. Contreras CM, Azamar-Arizmendi G, Saavedra M, Hernández-Lozano M. A five-day gradual reduction regimen of chlormadinone reduces premenstrual anxiety and depression: a pilot study. Arch Med Res 2006; 37 (7): 907–13.
10. Anthuber S, Schramm GA, Heskamp ML. Six-month evaluation of the benefits of the low-dose combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg in young women: results of the prospective, observational, non-interventional, multicentre TeeNIS study. Clin Drugs Investig 2010; 30 (4): 211–20.
11. Bitzer J. Belara – proven benefits in daily practice. Eur J Contracept Reprod Health Care 2005; 10 (Suppl. 1): 19–25.
12. Caruso S, Rugolo S, Agnello C et al. Quality of sexual life in hyperandrogenic women treated with an oral contraceptive containing chlormadinone acetate. J Sex Med 2009; 6 (12): 3376–84.
13. De LeoV, di Sabatino A, Musacchio MC et al. Effect of oral contraceptives on markers of hyperandrogenism and SHBG in women with polycystic ovary syndrome. Contraception 2010; 82 (3): 276–80.
14. Kerscher M, Reuther T, Bayrhammer J, Schramm G. Effects of an oral contraceptive containing chlormadinone and ethinylestradiol on acne-prone skin of women of different age groups: an open-label, single-centre, phase IV study. Clin Drugs Investig 2008; 28 (11): 703–11.
15. Lello S, Primavera G, Colonna L et al. Effects of two estroprogestins containing ethynilestradiol 30 microg and drospirenone 3 mg and ethynilestradiol 30 microg and chlormadinone 2 mg on skin and hormonal hyperandrogenic manifestations. Gynecol Endocrinol 2008; 24 (12): 718–23.
16. Plewig G, Cunliffe WJ, Binder N, Höschen K. Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial. Contraception 2009; 80 (1): 25–33.
17. Uras R, Orrù M, Pani F et al. Endocrinological, metabolic and clinical features of treatment with oral contraceptive formulation containing ethinylestradiol plus chlormadinone acetate in nonobese women with polycystic ovary syndrome. Contraception 2010; 82 (2): 131–8.
18. Rabe T, Hartschuh E, Wahlstrom T et al. Endometrial safety of a novel monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen over six cycles. Contraception 2010; 82 (4): 358–65.
19. Guido M, Romualdi D, Campagna G et al. Ethinylestradiol-chlormadinone acetate combination for the treatment of hirsutism and hormonal alterations of normal-weight women with polycystic ovary syndrome: evaluation of the metabolic impact. Reprod Sci 2010; 17 (8): 767–75.
20. Gómez M Vázquez, Navarra Amayuelas R, Lamarca M et al. Ethinylestradiol/Chlormadinone acetate for use in dermatological disorders. Am J Clin Dermatol (Suppl. 1) 2011; 6 (12): 13–9.
21. Uras R, Orrù M, Etzi R et al. Evidence that in healthy young women, a six-cycle treatment with oral contraceptive containing 30 mcg of ethinylestradiol plus 2 mg of chlormadinone acetate reduces fat mass. Contraception 2009; 79 (2): 117–21.
22. Göretzlehner G, Waldmann-Rex S, Schramm GA. Extended cycles with the combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg: pooled analysis of data from three large-scale, non-interventional, observational studies. Clin Drug Investig 2011; 31 (4): 269–77.
23. Huber JC, Heskamp ML, Schramm GA. Effect of an oral contraceptive with chlormadinone acetate on depressive mood: analysis of data from four observational studies. Clin Drugs Investig 2008; 28 (12): 783–91.
24. Alhenc-Gelas M, Plu-Bureau G, Guillonneau S et al. Impact of progestagens on activated protein C (APC) resistance among users of oral contraceptives. Thromb Haemost 2004; 2 (9): 1594–600.
25. Cagnacci A, Ferrari S, Tirelli A et al. Insulin sensitivity and lipid metabolism with oral contraceptives containing chlormadinone acetate or desogestrel: a randomized trial. Contraception 2009; 79 (2): 111–6.
26. Brucker C, Hedon B et al. Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen. Contraception 2010; 81 (6): 501–9.
27. Meier CR. Health risks of oral contraceptive. Ther Umsch 2011; 68 (6): 345–52.
28. Terlinden R, Uragg H, Göhler K, Kneip C. Pharmacokinetics of chlormadinone acetate following single and multiple oral dosing of chlormadinone acetate (2 mg) and ethinylestradiol (0.03 mg) and elimination and clearance of a single dose of radiolabeled chlormadinone acetate. Contraception 2006; 74 (3): 239–44.
29. Chabbert-Buffet N, Amoura Z, Scarabin PY et al. Pregnane progestin contraception in systemic lupus erythematosus: a longitudinal study of 187 patients. Contraception 2011; 83 (3): 229–37.
30. Conard J, Plu-Bureau G, Bahi N et al. Progestogen-only contraception in women at high risk of venous thromboembolism. Contraception 2004; 70 (6): 437–41.
31. Rosendaal F, Helmerhorst Vandenbrouke F. Female hormones and thrombosis. J Arterioscler Thromb Vascul Biol 2002; 22: 201–10.
32. Pushparajah DS, Röhm P, Höschen K et al. Safety data and beneficial effects of the combined oral contraceptive ethinylestradiol 0.03 mg/chlormadinone acetate 2 mg (Belara®): a 13-cycle, observational study in routine clinical practice. Clin Drug Investig 2011; 31 (20): 121–34.
33. Schramm G, Steffens D. A 12-month evaluation of the CMA-containing oral contraceptive Belara: efficacy, tolerability and anti-androgenic properties. Contraception 2003; 67 (4): 305–12.
34. Schramm G, Heckes B. Switching hormonal contraceptives to a chlormadinone acetate-containing oral contraceptive – the Contraceptive Switch Study. Contraception 2007; 76 (2): 84–90.
35. Schramm GA, Schrah G. The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adult and adolescent women. Contraception 2011; 84 (4): 390–401.
36. Spona J, Binder N, Höschen K, Feichtinger W. Suppression of ovarian function by a combined oral contraceptive containing 0.02 mg ethinyl estradiol and 2 mg chlormadinone acetate given in a 24/4-day intake regimen over three cycles. Fertil Steril 2010; 94 (4): 1195–201.
37. Bitzer J, Frey B, von Schönau M et al. Twenty or thirty microgram ethinyloestradiol in an oral contraceptive: does it make a difference in the mind and the daily practise of gynaecologists and general practitioners? Eur J Contracept Reprod Health Care 2009; 14 (4): 258–67.
38. Winkler UH, Sudik R. The effects of two monophasic oral contraceptives containing 30 mcg of ethinylestradiol and either 2 mg of chlormadinone acetate or 0.15 mg of desogestrel on lipid, hormone and metabolic parameters. Contraception 2009; 79 (1): 15–23.
39. Winkler UH, Röhm P, Höschen K. An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables. Contraception 2010; 81 (5): 391–400.
40. Zahradnik HP, Hanjalic-Beck A. Efficacy, safety and sustainability of treatment continuation and results of an oral contraceptive containing 30 mcg ethinylestradiol and 2 mg chlormadinone acetate, in long-term usage (up to 45 cycles) – an open-label, prospective, noncontrolled, office-based Phase III study. Contraception 2008; 77 (5): 337–43.
Авторы
А.Л.Унанян, Ю.М.Коссович
ГБОУ ВПО Первый МГМУ им. И.М.Сеченова Минздрава РФ