Menstrual cycle normalization with dydrogesterone
Objective. To analyze data in a subgroup of female patients from Russia, who took part in post-marketing observational study on the use of dydrogesterone to normalize their menstrual cycle (MC). Subjects and methods. The observational study (NCT01711216) aimed at evaluating the efficacy of dydrogesterone used in the treatment of menstrual irregularities was conducted in several countries (Russia, Ukraine, Kazakhstan, and Uzbekistan). The paper analyzes data on 389 women from the centers located in Russia. Results. In the Russian population, at least one or more normal MCs could be achieved in 99.0% of the patients using dydrogesterone (in 99.1% in the core study). After treatment completion, at least 6 consecutive normal MCs were observed in 76.7% of the patients (in 79.1% in the core study). There was a significant relationship (p = 0.0016) and a direct correlation (p = 0.0377) between the number of treatment cycles and the preserved regular MCs. High satisfaction with therapy results was observed in 91.6% of the patients; the clinical response to treatment was regarded as good or excellent in 90.3% of patients, as assessed by medical investigators. 1.8% of patients had adverse events; all of the latter were mild or moderate. Conclusion. Dydrogesterone therapy for menstrual irregularities demonstrated high efficacy and good tolerability, as well as excellent patient treatment satisfaction. A direct relationship was noted between the duration of dydrogesterone usage (the number of treatment cycles) and that of the preserved normal MCs after treatment completion.Podzolkova N.M., Tatarchuk T.F., Doshchanova A.M., Eshimbetova G., Sumyatina L.V.
Keywords
dydrogesterone
polymenorrhea
oligomenorrhea
metrorrhagia
menstruation
menstrual irregularities
abnormal uterine bleeding
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Received 06.04.2018
Accepted 20.04.2018
About the Authors
Nataliya M. Podzolkova, 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. Tel.: +74997481530. E-mail: podzolkova@gmail.comTatyana F. Tatarchuk, MD, professor, Corresponding Member of NAMS of Ukraine, Honored Worker of Science and Technology of Ukraine,
Deputy Director for Research, Institute of Pediatrics, Obstetrics and Gynecology, National Academy of Medical Sciences of Ukraine.
04050, Ukraine, Kiev, Platon Mayboroda str. 8. Tel.: +38 (044) 483-80-87. E-mail: ipag.gyn@femina-health.org
Aygerim M. Doshchanova, MD, professor, chief freelance gynecologist-endocrinologist of the Ministry of Health of the Republic of Kazakhstan,
Astana. Tel.: +77172408372. E-mail: talmas_medicus@mail.ru
Gulsara Z. Eshimbetova, MD, Professor of the Department of Obstetrics, Gynecology and Perinatal Medicine, Tashkent Institute of Postgraduate Medical Education, Tashkent, Uzbekistan. Tel.: +998712681744. E-mail: kaf_ginekologiya-perinatal@tipme.uz
Liliana V. Sumyatina, Ph.D., Associate Professor of the Department of Obstetrics and Gynecology, Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia. 125993, Russia, Moscow, Barrikadnaya str. 2/1. Tel.: +74997481530. E-mail: sumyatin@yandex.ru
For citations: Podzolkova N.M., Tatarchuk T.F., Doshchanova A.M., Eshimbetova G.Z, Sumyatina L.V. Menstrual cycle normalization with dydrogesterone. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2018; (6): 70-6. (in Russian)
https://dx.doi.org/10.18565/aig.2018.6.70-76
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