Polikistik over sendromunda hirsutizm tedavisi için dienogest veya drospirenon içeren iki farklı oral kontraseptifin karşılaştırıldığı prospektif randomize bir çalışma
Abstract
Amaç:Polikistik over sendromlu kadınlarda hirsutizm tedavisinde drospirenon ve dienogest içeren iki oral kontraseptifin klinik etkinliğini karşılaştırmak için prospektif randomize bir çalışma yapıldı.
Hastalar ve Yöntem:Bu çalışmaya orta-şiddetli hirsutizm tanısı olan 50 kadın alındı. Yirmi beş hastaya 6 ay boyunca oral 0,03 mg etinil estradiol ve 3 mg drospirenon 21/7 (Grup 1) verildi. 25 hastalık bir başka gruba 6 ay boyunca oral 0,03 mg etinil estradiol ve 2 mg dienogest 21/7 (Grup 2) verildi. Hirsutizm, 6 ay sonra Ferriman-Gallwey (FG) puanlama sistemi kullanılarak değerlendirildi. Her iki tedavinin de 6 ayının sonrasında görülen hormonal seviyeler bazal değerlerle ve birbirleriyle karşılaştırıldı.
Bulgular:Hirsutizm için F-G skorlarında (ortalama ± SD) Grup 1\'de (19,3±6,2\'den 9,7±3,5’ye, p<0,001) ve Grup 2\'de (19,5±5,8\'den 8,9±3,8’e, p<0,001) bir iyileşme gözlenmiştir. Tedavi öncesi ve sonrası hirsutizm skorları gruplar arasında karşılaştırılabilir olmuştur. Her iki grupta da tedaviden sonra toplam ve serbest testosteron düzeyleri anlamlı olarak azalmıştır. Cinsiyet hormonu bağlayıcı globulin düzeyleri, 6 aylık dönemde her iki grupta da anlamlı olarak artmıştır.
Sonuç:Hirsutizmin, hem drospirenon hem de dienogest içeren kombine oral kontraseptiflerle (KOK) tedavisi, herhangi bir yan etkisi olmadan kıyaslanabilir etkilere sahiptir.
References
- 1. Batukan C, Muderris II. Efficacy of a new oral contraceptive containing drospirenone and ethinyl estradiol in the long-term treatment of hirsutism. Fertil Steril 2006;85:436–40.
- 2. Meier RK. Polycystic Ovary Syndrome. Nursing Clin Nor Am 2018;53:407-420.
- 3. Wiegratz I, Jung-Hoffmann C, Kuhl H. Effect of two oral contraceptives containing ethinylestradiol and gestodene or norges timate Contraception 1995;51:341–6.
- 4. Oláh KS. The modern management of hirsutism. Rev Gynaecol Practise 2004;4:211–20.
- 5. Murphy A, Cropp CS, Smith BS, Burkman RT, Zacur HA. Effect of low-dose oral contraceptive on gonadotropins, androgens, and sex hormone binding globulin in nonhirsute women. Fertil Steril 1990;53: 35-9.
- 6. Azziz R. The evaluation and management of hirsutism. Obstet Gynecol 2003;101:995–1007.
- 7. Krattenmacher R. Drospirenone: pharmacology and pharmacokinetics of unique progestogen. Contraception 2000;62:29–38.
- 8. van Vloten WA, van Haselen CW, van Zuuren EJ, Gerlinger C, Heithecker R. The effect of 2 combined oral contraceptives containing either drospirenone or cyproterone acetate on acne and seborrhea. Cutis 2002;69:2–15.
- 9. Thorneycroft H, Gollnick H, Schellschmidt I. Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment. Cutis 2004; 74:123–30.
- 10. G. Oner, Muderris II. “A prospective randomized trial comparing low dose ethinyl estradiol and drospirenone 24/4 combined oral contraceptive versus ethinyl estradiol and drospirenone 21/7 combined oral contraceptive in the treatment of hirsutism”, Contraception, 2011; 84; 508-511.
- 11. Carlo CD, Gargano V, Sparice S, Tommaselli GA, Bifulco G, Nappi C. Effects of an oral contraceptive containing estradiol valerate and dienogest on circulating androgen levels and acne in young patients with PCOS: an observational preliminary study Gynecol Endocrinol, 2013; 29: 1048-1050.
- 12. Bachmann G, Sulak PJ, Sampson-Landers C, Benda N, Marr J. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone. Contraception 2004;70:191–8.
- 13. Pearlstein TB, Bachmann GA, Zacur HA, Yonkers KA. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception 2005;72:414–21.
- 14. KoltunW, Lucky AW, Thiboutot D. Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled trial. Contraception 2008;77: 249-56.
- 15. Homburg R. What is polycystic ovarian syndrome? A proposal for a consensus on the definition and diagnosis of polycystic ovarian syndrome. Hum Reprod 2002;17:2495–9.
- 16. Barbieri RL. Hyperandrogenic disorders. Clin Obstet Gynecol 1990; 33:640–54.
- 17. Palombo-Kinne E, Schellschmidt I, Schumacher U, Gra¨ser T. Efficacy of a combined oral contraceptive containing 0,030 mg ethinylestradiol/2mg dienogest for the treatment of papulopustular acne in comparison with placebo and 0,035 mg ethinylestradiol/2 mg cyproterone acetate. Contraception 2009;79: 282–99.
- 18. Caruso S, Agnello C, Romano M. Preliminary study on the effect of four-phasic estradiol valerate and dienogest (E2V/DNG) oral contraceptive on the quality of sexual life. J Sex Med 2011;8: 2841-50.
- 19. Guida M, Bifulco G, Di Spiezio Sardo A. Review of the safety, efficacy and patient acceptability of the combined dienogest/estradiol valerate contraceptive pill. Int J Womens Health 2010;2: 279-90
- 20. Del Marmol V, Teichmann A, Gertsen K. The role of combined oral contraceptives in the management of acne and sebborhea. Eur J Contracep Reprod Health Care 2004;9:107–24.
- 21. Regidor PA, Schindler AE. Antiandrogenic and antimineralocorticoid health benefits of COC containing newer progestogens: dienogest and drospirenone. Oncotarget 2017; 8: 34-42
A prospective randomized trial comparing two different oral contraceptive containing dienogest or drospirenone for the treatment of hirsutism in policystic ovarian syndrome
Abstract
Purpose:A prospective randomized trial was conducted to compare the clinical efficacy of two oral contraceptives containing drospirenone and dienogest in the treatment of hirsutism in women with policystic ovarian syndrome.
Patients and Methods:Fifty women with moderate to severe hirsutism were recruited in this study. Twenty-five patients received oral 0.03 mg ethinyl estradiol and 3 mg drospirenone 21/7 regimen (Group 1) for 6 months. Another group of 25 patients received oral 0.03 mg ethinyl estradiol and 2 mg dienogest 21/7 regimen (Group 2) for 6 months. Hirsutism was assessed after 6 months using the Ferriman–Gallwey (F-G) scoring system. Hormonal levels after 6 months of both therapies were compared with baseline values and each other.
Results:An improvement in the F-G scores for hirsutism (mean±SD) was observed in Group 1 (19.3 ± 6.2 to 9.7 ± 3.5, p<.001) and in Group 2 (19.5 ± 5.8 to 8.9 ± 3.8, p<.001). Pre- and post-treatment hirsutism scores were comparable between the groups. Total and free testosterone levels decreased significantly after the therapy in both groups. The sex hormone-binding globulin levels increased significantly in both groups during the 6-month period.
Conclusion:The treatment of hirsutism with both combined oral contraceptives (COCs) containing drospirenone and dienogest have comparable effects without any side effect.
References
- 1. Batukan C, Muderris II. Efficacy of a new oral contraceptive containing drospirenone and ethinyl estradiol in the long-term treatment of hirsutism. Fertil Steril 2006;85:436–40.
- 2. Meier RK. Polycystic Ovary Syndrome. Nursing Clin Nor Am 2018;53:407-420.
- 3. Wiegratz I, Jung-Hoffmann C, Kuhl H. Effect of two oral contraceptives containing ethinylestradiol and gestodene or norges timate Contraception 1995;51:341–6.
- 4. Oláh KS. The modern management of hirsutism. Rev Gynaecol Practise 2004;4:211–20.
- 5. Murphy A, Cropp CS, Smith BS, Burkman RT, Zacur HA. Effect of low-dose oral contraceptive on gonadotropins, androgens, and sex hormone binding globulin in nonhirsute women. Fertil Steril 1990;53: 35-9.
- 6. Azziz R. The evaluation and management of hirsutism. Obstet Gynecol 2003;101:995–1007.
- 7. Krattenmacher R. Drospirenone: pharmacology and pharmacokinetics of unique progestogen. Contraception 2000;62:29–38.
- 8. van Vloten WA, van Haselen CW, van Zuuren EJ, Gerlinger C, Heithecker R. The effect of 2 combined oral contraceptives containing either drospirenone or cyproterone acetate on acne and seborrhea. Cutis 2002;69:2–15.
- 9. Thorneycroft H, Gollnick H, Schellschmidt I. Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment. Cutis 2004; 74:123–30.
- 10. G. Oner, Muderris II. “A prospective randomized trial comparing low dose ethinyl estradiol and drospirenone 24/4 combined oral contraceptive versus ethinyl estradiol and drospirenone 21/7 combined oral contraceptive in the treatment of hirsutism”, Contraception, 2011; 84; 508-511.
- 11. Carlo CD, Gargano V, Sparice S, Tommaselli GA, Bifulco G, Nappi C. Effects of an oral contraceptive containing estradiol valerate and dienogest on circulating androgen levels and acne in young patients with PCOS: an observational preliminary study Gynecol Endocrinol, 2013; 29: 1048-1050.
- 12. Bachmann G, Sulak PJ, Sampson-Landers C, Benda N, Marr J. Efficacy and safety of a low-dose 24-day combined oral contraceptive containing 20 micrograms ethinylestradiol and 3 mg drospirenone. Contraception 2004;70:191–8.
- 13. Pearlstein TB, Bachmann GA, Zacur HA, Yonkers KA. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception 2005;72:414–21.
- 14. KoltunW, Lucky AW, Thiboutot D. Efficacy and safety of 3 mg drospirenone/20 mcg ethinylestradiol oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: a randomized, double-blind, placebo-controlled trial. Contraception 2008;77: 249-56.
- 15. Homburg R. What is polycystic ovarian syndrome? A proposal for a consensus on the definition and diagnosis of polycystic ovarian syndrome. Hum Reprod 2002;17:2495–9.
- 16. Barbieri RL. Hyperandrogenic disorders. Clin Obstet Gynecol 1990; 33:640–54.
- 17. Palombo-Kinne E, Schellschmidt I, Schumacher U, Gra¨ser T. Efficacy of a combined oral contraceptive containing 0,030 mg ethinylestradiol/2mg dienogest for the treatment of papulopustular acne in comparison with placebo and 0,035 mg ethinylestradiol/2 mg cyproterone acetate. Contraception 2009;79: 282–99.
- 18. Caruso S, Agnello C, Romano M. Preliminary study on the effect of four-phasic estradiol valerate and dienogest (E2V/DNG) oral contraceptive on the quality of sexual life. J Sex Med 2011;8: 2841-50.
- 19. Guida M, Bifulco G, Di Spiezio Sardo A. Review of the safety, efficacy and patient acceptability of the combined dienogest/estradiol valerate contraceptive pill. Int J Womens Health 2010;2: 279-90
- 20. Del Marmol V, Teichmann A, Gertsen K. The role of combined oral contraceptives in the management of acne and sebborhea. Eur J Contracep Reprod Health Care 2004;9:107–24.
- 21. Regidor PA, Schindler AE. Antiandrogenic and antimineralocorticoid health benefits of COC containing newer progestogens: dienogest and drospirenone. Oncotarget 2017; 8: 34-42
Details
| Primary Language | English |
|---|---|
| Subjects | Clinical Sciences |
| Journal Section | Research Articles |
| Authors | |
| Publication Date | December 16, 2020 |
| Submission Date | September 16, 2019 |
| Published in Issue | Year 2021Volume: 12 Issue: 1 |
