EVALUATION OF THE EFFICACY AND SAFETY OF A CONTRACEPTIVE CONTAINING ETHINYLESTRADIOL IN COMBINATION WITH CHLORMADINONE ACETATE


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Abstract

Objective. To evaluate the efficacy and safety of an agent containing ethinylestradiol (EE) in combination with chlormadinone acetate (CMA) in contraceptive-needing patients within the framework of the pharmacological epidemiological observational project. Subjects and methods. The study enrolled 161 female patients needing contraception. All patients had no contraindications to combined oral contraceptives (COCs) and conditions in which COCs should be used with caution. All the women took EE in combination with CMA in a 21/7 cyclic regimen for contraception. To evaluate its efficacy and safety, the occurrence of pregnancy was assessed within 6 months of EE/CMA intake. To estimate safety parameters, the changes in body weight, blood pressure, and hemostatic parameters that characterized the risk of hypercoagulation disorders were assessed. Results. During the follow-up, no pregnancy occurred in the patients included in the study. Significant changes in weight gain, blood pressure, and improvement in the blood coagulation potential were not observed. The hormonal contraceptive with CMA demonstrated an additional positive effect on the women’s emotional state. Conclusion. The findings may conclude that EE in combination with CMA is highly effective and safe and may also highlight its additional positive effects.

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About the authors

Nataliya Mikhaylovna PODZOLKOVA

Email: podzolkova@gmail.com
Doctor of Medicine, Professor, Department of Obstetrics and Gynecology, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia. 125993, Russia, Moscow, Barrikadnaya str. 2/1

Yuliya Alekseevna KOLODA

Email: julkol@yandex.ru
PhD, Assistant Professor, Department of Obstetrics and Gynecology, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia 125993, Russia, Moscow, Barrikadnaya str. 2/1

Vera Vyacheslavovna KORENNAYA

Email: drkorennaya@mail.ru
PhD, Assistant Professor, Department of Obstetrics and Gynecology, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia 125993, Russia, Moscow, Barrikadnaya str. 2/1

Viktor Alekseevich AKSENENKO

Email: aksenenko_@mail.ru
chief obstetrician-gynecologist, Ministry of health of the Stavropol territory, Doctor of Medicine, Professor, Head of the department of Obstetrics and Gynecology, Stavropol State Medical University. 355000, Russia, Stavropol, Mira str. 310

Nailya Edgarovna BAKIROVA

Email: nailyabak@yandex.ru
Candidate of Medical Sciences, Senior Lecturer of Department of Surgery, Kazan (Volga) Federal University; Head of the Department of gynecology, KORL LLC 420059, Russia, Kazan, Daurskaya str. 12

Anna Valeryevna VORONTSOVA

Email: а_valerevna@mail.ru
Candidate of Medicine, Associate Professor of the Department of Obstetrics and Gynecology, Ural State Medical University, Ministry of Health of Russia 620215, Russia, Yekaterinburg, Repina str. 1

Elena Vladimirovna ENKOVA

Email: enkova@bk.ru
Doctor of Medical Science, Professor of the Surgery, Obstetrics and Gynecology Department of the Institute of Additional Postgraduate Education, N.N. Burdenko Voronezh State Medical University. 394024, Russia, Voronezh, Studencheskaya str. 10

L. Yu KARAKHALIS

Email: lomela@mail.ru
MD, PhD, professor, the Department of Obstetrics, Gynecology, and Perinatology, Faculty of Postgraduate Education, Kuban State Medical University, Ministry of Health of Russia. 350063, Russia, Krasnodar, Sedina str., 4

Nadezhda Yuryevna KATKOVA

Email: rector@gma.nnov.ru
Department of Obstetrics and Gynecology, Postgraduate Education Faculty, Nizhny Novgorod State Medical Academy. 603005, Russia, Nizhny Novgorod, Minin and Pozharsky sq. 10/1

Galina Nikolaevna MINKINA

Email: minkinagn@mail.ru
Doctor of Medicine, Professor of Department of Obstetrics and Gynecology, A.I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia 127473, Russia, Moscow, Delegatskaya str. 20/1

Elena V. MISHARINA

Email: mishellena@gmail.com
PhD, senior researcher at the Department of Endocrinology, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology. 199034, Russia, Saint Petersburg, Mendeleevskaya line 3

Anna Alexandrovna Olina

Email: olina29@mail.ru
Doctor of Medicine, Professor of Department of obstetrics and gynecology, Academician E.A. Vagner Perm State Medical University, Ministry of Health of Russia. 614990, Russia, Perm, Petropavlovskaya str. 26

Larisa Stepanovna SOTNIKOVA

Email: profmed.tomsk@gmail.com
Doctor of Medicine, Professor, Siberian State Medical University, Ministry of Health of Russia. 634050, Russia, Tomsk, Moscovsky trakt 2

Natalia V. SPIRIDONOVA

Email: nvspiridonova@mail.ru
Doctor of Medicine, Professor, the Head of the Department of Obstetrics and Gynecology Obstetrics, Institution of Postgraduate Studies, Samara State Medical University Samara. 443099, Russia, Samara, Chapayevskaya str. 8

Ludmila Vladimirovna TKACHENKO

Email: Tkachenko.fuv@mail.ru
Doctor of Medicine, Professor, Head of Department of obstetrics and gynecology, Faculty of advanced training of doctors, мVolgograd State Medical University 400131, Russia, Volgograd, Pavshikh Bortsov Sq. 1

Armine Robertovna KHACHATURYAN

Email: armine2709@mail.ru
Associate Professor of the Department of Obstetrics, Gynecology and Reproductology, Saint Petersburg State University. 199034, Russia, St-Petersburg, University embankment, 7-9

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