Retrospective Real World Data Research Program in Adolescents under 18 years old with a History of Dydrogesterone Treatment for Menstrual Disorders

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Abstract

Objective: To obtain the comprehensive data on the efficacy and safety 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.

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About the authors

Elena V. Uvarova

Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of the Russian Federation

Author for correspondence.
Email: elena_uvarova@yandex.ru

Corresponding Member of RAS, Dr. Med. Sci., Professor

Russian Federation, Moscow

Elena P. Khashchenko

Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of the Russian Federation

Email: khashchenko_elena@mail.ru

PhD, Senior Researcher

Russian Federation, Moscow

Irina A. Salnikova

Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of the Russian Federation

Email: i_chumakova@mail.ru

PhD, Researcher

Russian Federation, Moscow

Vera O. Andreeva

Scientific Research Institute of Obstetrics and Pediatrics, Rostov State Medical University, Ministry of Health of the Russian Federation

Email: vandreeva2008@yandex.ru

Dr. Med. Sci.

Russian Federation, Rostov-on-Don

Nina A. Funda

Children's Regional Clinical Hospital, Ministry of Health of the Krasnodar Territory

Email: nfunda@yandex.ru

Chief Obstetrician-Gynecologist

Russian Federation, Krasnodar

Elena E. Khramova

Scientific Center for Family Health and Human Reproduction

Email: elenacramova.irc@gmail.com

PhD

Russian Federation, Irkutsk

Svetlana V. Subbotina

Regional Perinatal Center

Email: sub1966@yandex.ru

PhD

Russian Federation, Chelyabinsk

Angela I. Tulendinova

Kuban State Medical University, Ministry of Health of the Russian Federation

Email: atulendinova@mail.ru

obstetrician-gynecologist

Russian Federation, Krasnodar

Margarita A. Mardoyan

Presidential Perinatal Center, Ministry of Health of the Chuvash Republic

Email: ritulyan@yandex.ru

Chief Freelance Specialist Gynecologist

Russian Federation, Cheboksary

Elena A. Gorodnova

Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of the Russian Federation

Email: e_gorodnova@oparina4.ru

PhD

Russian Federation, Moscow

Gennady T. Sukhikh

Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of the Russian Federation

Email: g_sukhikh@oparina4.ru

Dr. Med. Sci., Professor, Academician of RAS, Director

Russian Federation, Moscow

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Supplementary files

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2. Fig. 1. Frequency of successful treatment of menstrual cycle disorders depending on the diagnosis according to ICD-10

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3. Fig. 2. Response rate to dydrogesterone treatment in adolescent patients

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4. Fig. 3. Groups of patients depending on the duration

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