Efficiency of the combination of transdermal estrogens and a hormone-releasing intrauterine system for the correction of menopausal symptoms

Abstract

Hypothesis/aims of study. The aim of this study was to assess the efficiency of Mirena (levonorgestrel-releasing intrauterine system) combined with EstroGel (17β-estradiol transdermal gel) being applied in the test group of peri- and postmenopausal women as menopausal hormonal therapy.

Study design, materials and methods. The study involved 62 patients aged 42 to 55 years. The main group included 33 women who were prescribed Mirena in combination with EstroGel. The control group consisted of 29 women who were prescribed a combined two-phase tablet preparation containing micronized 17β-estradiol as an estrogen component and dydrogesterone as a gestagen component. The condition of the patients was evaluated at the beginning of therapy and after 3, 6 and 12 months.

Results. During therapy, patients in the main group decreased climacteric symptoms and improved lipid profile and blood biochemical parameters characterizing the hepatobiliary system. Patients in the control group had a comparable decrease in menopausal symptoms; however, there were changes in biochemical parameters, such as hypertriglyceridemia and a significant increase in bilirubin and transaminases, which required discontinuation of therapy. All the patients using Mirena in combination with EstroGel demonstrated good tolerability, efficiency of the therapy and no significant symptoms requiring its withdrawal. During the menopausal hormonal therapy, there were no cases of relapse of endometrial hyperplasia, growth of myomatous nodes and an increase in endometriosis prevalence. Patients in the control group during the first three months of therapy noted acyclic spotting, breast engorgement and tenderness, headaches, and exacerbation of cholelithiasis, which resulted in decreased adherence to therapy.

Conclusion. The use of estrogen transdermally in combination with the intrauterine administration of levonorgestrel is an effective and safe method that helps to relieve menopausal symptoms and to improve the health and quality of life of women with extragenital pathology, endometrial and mammary gland hyperplastic processes, endometriosis, and menometrorrhagia.

Keywords

perimenopause / climacteric syndrome / menopausal hormone therapy

References

[1] Российский статистический ежегодник: cтатистический сборник. – М.: Госкомстат России, 2018. – 694 с. [Rossiyskiy statisticheskiy ezhegodnik: ctatisticheskiy sbornik. Moscow: Goskomstat Rossii; 2018. 694 р. (In Russ.)]

[2] Пестрикова Т.Ю., Даниленко И.А., Ковалева Т.Д., Волошенко В.Х. Применение левоноргестрелсодержащей внутриматочной системы «Мирена» в лечении гиперпластических процессов эндометрия у женщин в перименопаузальном периоде // Consilium Medicum. – 2007. – Т. 9. – № 6. – С. 32–35. [Pestrikova TYu, Danilenko IA, Kovaleva TD, VoloshenkoVKh. Primeneniye levonorgestrelsoderzhashchey vnutrimatochnoy sistemy ‟Mirena” v lechenii giperplasticheskikh protsessov endometriya u zhenshchin v perimenopauzal’nom periode. Consilium Medicum. 2007;9(6):32-35. (In Russ.)]

[3] Шестакова И.Г., Хамошина М.Б., Кайгородова Л.А. Дифференцированный подход к назначению левоноргестрелвыделяющей внутриматочной системы // Доктор.Ру. – 2014. – № 8-2. – C. 5−11. [Shestakova IG, Khamoshina MB, Kaygorodova LA. Varying approach to using levonorgestrel-releasing intrauterine system. Doktor.ru. 2014;(8-2):5-11. (In Russ.)]

[4] Иловайская И.А., Войташевский К.В. Молодильные яблоки XXI столетия // StatusPraesens. Гинекология. Акушерство. Бесплодный брак. – 2015. – № 5. – С. 80–86. [Ilovayskaya IA, Voytashevskiy KV. Molodil’nyye yabloki XXI stoletiya. StatusPraesens. Ginekologiia. Akusherstvo. Besplodnyi brak. 2015;(5):80-86. (In Russ.)]

[5] Сметник В.П. Заместительная гормонотерапия в климактерии // StatusPraesens. Гинекология. Акушерство. Бесплодный брак. – 2011. – № 2.– С. 50–54. [Smetnik VP. Zamestitel’naya gormonoterapiya v klimakterii. StatusPraesens. Ginekologiia. Akusherstvo. Besplodnyi brak. 2011;(2):50-54. (In Russ.)]

[6] Ярмолинская М.И., Тарасова М.А., Высочина Д.А. Гормональная заместительная терапия с внутриматочным применением левоноргестрела у женщин с генитальным эндометриозом // Журнал акушерства и женских болезней. – 2008. – Т. 57. – № 2. – С. 17–23. [Yarmolinskaya MI, Tarasova MA, Vysochina DA. Gormonal’naya zamestitel’naya terapiya s vnutrimatochnym primeneniyem levonorgestrela u zhenshchin s genital’nym endometriozom. Journal of obstetrics and women’s diseases. 2008;57(2):17-23.(In Russ.)]

[7] Wildemeersch D. Why perimenopausal women should consider to use a levonorgestrel intrauterine system. Gynecol Endocrinol. 2016;32(8):659-661. https://doi.org/10.3109/09513590.2016.1153056.

[8] Baber RJ, Panay N, Fenton A; IMS Writing Group. 2016 IMS Recommendations on women’s midlife health and menopause hormone therapy. Climacteric. 2015;19(2):109-150. https://doi.org/10.3109/13697137.2015.1129166.

[9] Lethaby A, Hussain M, Rishworth JR, Rees MC. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev. 2015;(4):CD002126. https://doi.org/10.1002/14651858.CD002126.pub3.

[10] Stuenkel CA, Davis SR, Gompel A, et al. Treatment of symptoms of the menopause: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(11):3975-4011. https://doi.org/10.1210/jc.2015-2236.

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Medvedevа I.N., Svyatchenko K.S.