Retrospective real world data research program in adolescents under 18 years old with a history of dydrogesterone treatment for menstrual bleeding disorders
Uvarova E.V., Khashchenko E.P., Salnikova I.A., Andreeva V.O., Funda N.A., Khramova E.E., Subbotina S.B., Tulendinova A.I., Mardoyan M.A., Gorodnova E.A., Sukhikh G.T.
Objective: To obtain the comprehensive data on the safety and efficacy of dydrogesterone (Duphaston) in adolescent girls with menstrual disorders in routine clinical practice.
Materials and methods: Retrospective analysis of medical records describing the use of dydrogesterone for menstrual disorders in adolescents under the age of 18 who were treated with this medication. The primary outcome was the achievement of menstrual-like reaction after one or three cycles of treatment.
Results: In total, medical charts of 1000 patients were analyzed, including 19 patients who received dydrogesterone treatment on two separate occasions, resulting in a total of 1019 treatment courses described in the report. Mean age was 14.9±1.6 years. The specific indications for Duphaston treatment initiation most commonly reported were as follows: irregular menstrual cycle, dysfunctional uterine bleeding, dysmenorrhea and secondary amenorrhea. Treatment success was achieved in 976 of 1019 cases (95.8%). The success rate did not show significant differences based on age and body mass index.
Conclusion: Dydrogesterone treatment normalized the menstrual cycle in adolescent patients suffering from menstrual bleeding disorders, including dysmenorrhea. Therapy with dydrogesterone demonstrated a favorable safety profile and was well tolerated by patients older than 9 years of age after menarche with menstrual disorders.
Authors' contributions: Uvarova E.V., Khashchenko E.P., Salnikova I.A., Andreeva V.O., Funda N.A., Khramova E.E., Subbotina S.V., Tulendinova A.I., Mardoyan M.A., Gorodnova E.A., Sukhikh G.T. – article idea development, collection information, writing the article.
Conflicts of interest: The authors declare no possible conflicts of interest.
Funding: Retrospective data collection and medical follow-up was supported by Abbott Laboratories Ltd.
Acknowledgements: The authors would like to express their gratitude to Nikolay Tabakaev and Yakov Pakhomov from MAG SARL for their invaluable assistance in medical writing during manuscript preparation.
Ethical Approval: The study protocol was reviewed and approved by the independent ethical committees (IECs) of all participating centers, and the IEC of the Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology of the Ministry of Health of Russia.
Patient Consent for Publication: Informed consent from the patient or their legal representative was not required for the use of information from medical records in the present study.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Uvarova E.V., Khashchenko E.P., Salnikova I.A., Andreeva V.O., Funda N.A., Khramova E.E., Subbotina S.B., Tulendinova A.I., Mardoyan M.A., Gorodnova E.A., Sukhikh G.T.
Retrospective real world data research program in adolescents under 18 years old with a history of
dydrogesterone treatment for menstrual bleeding disorders.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2025; (1): 88-96 (in Russian)
https://dx.doi.org/10.18565/aig.2025.14
Keywords
dydrogesterone
progestogen
abnormal uterine bleeding
adolescent
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Received 24.01.2025
Accepted 29.01.2025
About the Authors
Elena V. Uvarova, Corresponding Member of RAS, Dr. Med. Sci., Professor, Chief Freelance Specialist, Gynecologist of Children and Youth, Ministry of Health of Russia; Head of the 2nd Gynecological Department of the Institute of Neonatology and Pediatrics, V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia; President of the Association of Pediatric and Adolescent Gynecologists, Honored Scientist of the Russian Federation, Moscow, +7(916)148-04-76, elena uvarova@yandex.ruElena P. Khashchenko, PhD, Senior Researcher at the 2nd Gynecological Department (Gynecology of Pediatric and Adolescents), V.I. Kulakov NMRC for OG&P,
Ministry of Health Russia, Moscow, +7(926)278-68-33, khashchenko_elena@mail.ru
Irina A. Salnikova, PhD, Researcher at the 2nd Gynecological Department (Gynecology of Pediatric and Adolescents), V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia, Moscow, +7(926)563-46-50, i_chumakova@mail.ru
Vera O. Andreeva, Dr. Med. Sci., Chief Freelance Gynecologist of Children and Youth of the Southern Federal District and the North Caucasus Federal District;
Chief Researcher at the Obstetric and Gynecological Department, Scientific Research Institute of Obstetrics and Pediatrics, RostSMU, Ministry of Health of Russia, Rostov-on-Don, +7(903)401-01-51, vandreeva2008@yandex.ru
Nina A. Funda, Chief Obstetrician-Gynecologist of Children and Youth of the Stavropol Territory, +7(918)747-21-05, nfunda@yandex.ru
Elena E. Khramova, PhD, Head of the Department of Adolescent Gynecology, Scientific Center for Family Health and Human Reproduction; Chief Freelance Specialist in
Child and Adolescent Gynecology of the Ministry of Health of the Irkutsk Region, Irkutsk, +7(950)111-01-77, elenacramova.irc@gmail.com
Svetlana V. Subbotina, PhD, Regional Perinatal Center, Chelyabinsk, +7(919)335-18-08, sub1966@yandex.ru
Angela I. Tulendinova, obstetrician-gynecologist, Chief Freelance Obstetrician-Gynecologist of Children and Adolescents of the Ministry of Health of the Krasnodar Territory, +7(918)431-73-77, atulendinova@mail.ru
Margarita A. Mardoyan, Chief Freelance Specialist Gynecologist of Children and Youth in the Volga Federal District, +7(903)345-76-68, ritulyan@yandex.ru
Elena A. Gorodnova, PhD, Head of the Center for Scientific and Clinical Research, V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia, Moscow, +7(916)564-77-69, e_gorodnova@oparina4.ru
Gennady T. Sukhikh, Dr. Med. Sci., Professor, Academician of RAS, Director, V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia (Moscow), +7(495)438-18-00, g_sukhikh@oparina4.ru
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