DOI: https://doi.org/10.18370/2309-4117.2019.45.52-56

Polycystic ovary syndrome hormonal pharmacotherapy

С. Б. Чечуга

Abstract


Polycystic ovary syndrome (PCOS) is a diagnosis of exclusion and an important interdisciplinary problem. New recommendations for PCOS management were presented to the world in 2018. These recommendations have been developed by the CREPCOS (Australia), ESHRE, ASRM, and more than 30 other organizations. This document based on evidence-based medicine data and replaces previous recommendations for the PCOS management 2011. This article presents a translation of only one section of recommendations on the PCOS pharmacotherapy. It is also presents the results of the combined oral contraceptive Belara used for hyperandrogenic conditions.

The advantages of chlormadinone acetate, as a part of this drug, are that this progestin is a derivative of natural progesterone, and it is the only progestin with antiandrogenic effects with no cumulative dose (i.e., chlormadinone acetate has long-term predicted effect). Belara has a minimal risk of thromboembolic complications among other combined oral contraceptives, even in risk groups. The clinical efficacy of Belara in acne, seborrhea, and hyperandrogeny has been confirmed in numerous studies. In women taking this drug, a free testosterone decreased to the physiological level. The drug safety is also noted for fat and carbohydrate metabolism, which is reflected in a decrease of visceral fat.

Every day there is an increasing data on the approaches in the PCOS diagnosis, treatment and prevention, therefore the strategies will be changed in the near future; it is possible that the name of this state will change in the future. A thorough study of PCOS is the key to resolving issues related to metabolic syndrome, diabetes mellitus and intermediate-vascular diseases, i.e. conditions that directly affect the life duration and quality.


Keywords


polycystic ovary syndrome; obesity; visceral obesity; combined oral contraceptives; insulin resistance; dyslipidemia; Belara

References


Anthuber, S., Schramm, G., Heskamp, M.L. “Six-Month Evaluation of the Benefits of the Low-Dose Combined Oral Contraceptive Chlormadinone Acetate 2 mg/Ethinylestradiol 0.03 mg in Young Women.” Clin Drug Invest 30.4 (2010): 211–20.

Clinical recommendations on diagnostics, treatment and preventive measures for congenital dysfunction of the adrenal cortex in middle aged patients. Moscow (2016).

Conard, J., Plu-Bureau, G., Bahi, N., et al. “Progestogen-only contraception in women at high risk of venous thromboembolism.” Contraception 70 (2004): 437–41.

Druekmann, R. “Profile of the progesterone derivative ehlormadinone acetate – pharmocodynamie properties and therapeutic applications.” Contraception 79.4 (2009): 272–81.

Groth, K.E., Schrah, G., Schramm, G.A.K. “The efficacy and safety of a chlormadinone acetate-containing oral contraceptive: results of a meta-analysis of post-marketing surveillance studies non interventional trials in adult and adolescent women.” Manuscript in preparation (2010).

Jung-Hoffmann, C., Kuhl, H. “Divergent effects of two low-dose oral contraceptives on sex hormone-binding globulin and free testosterone.” Am J Obstet Gynecol 156 (1987): 199–203.

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 Drug Investig 28.11 (2008): 703–11.

Monash University on behalf of the NHMRC, Centre for Research Excellence in PCOS and the Australian PCOS Alliance. International evidence-based guideline for the assessment and management of polycystic ovary syndrome.” (2018).

Plewig, G., Cunliffe, W.J., Binder, N., Hoschen, 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 80.1 (2009): 25–33.

Rabe, T., Luxembourg, B., Ludwig, M., et al. “Contraception and Thrombophilia – A statement from the German Society for Gynecological Endocrinology and Reproductive Medicine and the Professional Association of German Gynaecologists.”

J Reproduktionsmed Endokrinol 8.1 (2011): 178–218.

Reznichenko, G.I. “Effect of combined oral contraceptives on metabolic processes and the risk of venous thrombosis.” Female doctor 4.66 (2016): 50–5.

Sabatini, R., Orsini, G., Cagiano, R., Loverro, G. “Noncontraceptive benefits of two combined oral contraceptives with antiandrogenic properties among adolescents.” Contraception 76.5 (2007): 342–7.

Schramm, G., Heckes, B. “Switching hormonal contraceptives to a chlormadinone acetate-containing oral contraceptive. The Contraceptive Switch Study.” Contraception 76.2 (2007): 84–90.

Schramm, G., Steffens, D. “Contraceptive efficacy and tolerability of chlormadinone acetate 2mg/ethinyl estradiol 0.03mg (Belara®). Results of a post-marketing surveillance study.” Clin Drug Invest 22 (2002): 221.

Schramm, G., Steffens, D. “A 12-month evaluation of the CMA-containing oral contraceptive Belara: efficacy, tolerability and antiandrogenic properties.” Contraception 67.4 (2003): 305.

The GRADE Working Group. GRADE handbook for grading quality of evidence and strength of recommendation. Version 3.2 (2009).

Uras, R., Orru, M., Etzi, R., et al. “Evidence that in healthy young women, a six-cycle treatment with oral contraceptive containing 30 meg of ethinylestradiol plus 2 mg of chlormadinone acetate reduces fat mass.” Contraception 79.2 (2009): 117–21.

Winkler, U.H., Sudik, R. “The effects of two monophasic oral contraceptives containing 30 mcg of ethinyl estradiol and either 2 mg of chlormadinone acetate or 0,15mg of desogestrel on lipid, hormone andmetabolic parameters.” Contraception 79 (2009): 15–23.

Worret, I., Arp, W., Zahradnik, H., et al. “Acne resolution rates: results of a single-blind, randomized, controlled, parallel phase III trial with EE/CMA (Belara) and EE/LNG (Microgynon).” Dermatology 203.1 (2001): 38–44.

Zahradnik, H., Goldberg, J., Andreas, J. “Efficacy and safety of the new antiandrogenic oral contraceptive Belara.” Contraception 57.2 (1998): 103–9.

Zahradnik, H.P., Hanjalic-Beck, A. “Efficacy, safety and sustainability of treatment continuation and results of an oral contraceptive containing 30 mg ethinyl estradiol and 2 mg chlormadinone acetate, in long-term usage (up to 45 cycles) – an open-label, prospective, non-controlled, office-based Phase III study.” Contraception 77.5 (2008): 337–43.


GOST Style Citations






Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

ISSN 2411-1295 (Online), ISSN 2309-4117 (Print)