Experience in the use of low-dosed levonorgestrel-containing intrauterine system LCS16 and combined oral contraceptive containing 30 mcg ethinyl estradiol and 3 mg drospirenone in young women

DOI

https://dx.doi.org/10.18565/aig.2021.11.230-236

Suturina L.V., Dikke G.B.
1) Scientific Center for Family Health and Human Reproduction Problems, Irkutsk, Russia; 2) F.I. Inozemtsev Academy of Medical Education, Saint Petersburg, Russia

Objective: To assess the satisfaction of young nulliparous and parous women using low-dosed levonorgestrel-releasing intrauterine system (LNG-IUS) or taking a combined oral contraceptive (COC) containing 30 mcg ethinyl estradiol and 3 mg drospirenone for 12 months.
Materials and methods: The study included women aged 18–29 years (n=147) who used LNG-IUS LCS16 (n=74) or took COC (30 mcg ethinyl estradiol and 3 mg drospirenone) (n=73). We studied general satisfaction of the patients using the contraceptive method and the Likert scale 6 and 12 months after applying one of the contraception methods. We assessed the satisfaction using the bleeding and pain profile, treatment-emergent adverse events (TEAE), preferences in contraception method and attrition rate.
Results: The percentage of patients who considered themselves to be ‘very satisfied’ and ‘satisfied’ with the contraception method was 90.3% (65/72) in the group using the IUD, and 97.3% (71/73) in the group taking the COC for 12 months. There was a decrease in bleeding and pain when patients used both methods and a decrease in the number of days of blood loss in the IUD group after 12 months. Аmenorrhea was observed in 7.7% (5/72) of the participants of the IUD group and in no cases in the COC group. The patients’ responses about the bleeding profile were ‘very satisfied’ or ‘rather satisfied’ in 94.3% (66/72) and 95.8% (69/73) of the cases, respectively. TEAE were revealed in 50% (36/72) of women in the LNG-IUS group and in 38.4% (28/73) of women in the COC group. After 12 months, 81.4% and 79.2% (57/73) women respectively wanted to continue using their method of contraception.
Conclusion: Both contraception methods, LNG-IUS and COC, are characterized by high satisfaction rates.

low-dosed levonorgestrel-containing intrauterine system

levonorgestrel

combined oral contraceptive

ethinyl estradiol

drospirenone

satisfaction

tolerance

Full text (in Russian)

Sedgh G., Singh S., Hussain R. Intended and unintended pregnancies worldwide in 2012 and recent trends. Stud. Fam. Plann. 2014; 45(3): 301-14. https://dx.doi.org/10.1111/j.1728-4465.2014.00393.x.
Federal State Statistics Service (ROSSTAT). Ministry of Health of the Russian Federation. Information and Publishing Center “Statistics of Russia”. Russia Reproductive Health Survey 2011. Executive summary. 2012.
Федеральная служба государственной статистики. Здравоохранение в России. Статистический сборник. Росстат. М.; 2017. 170с. Доступно по: http://www.gks.ru/free_doc/doc_2017/zdrav17.pdf [Healthcare in Russia. Statistical compendium. Rosstat. M, 2017. 170 p. Electronic resource. Access mode http://www.gks.ru/free_doc/doc_2017/zdrav17.pdf (in Russian)].
Montouchet C., Trussell J. Unintended pregnancies in England in 2010: costs to the National Health Service (NHS). Contraception. 2013; 87(2): 149-53. https://dx.doi.org/10.1016/j.contraception.2012.06.008.
Finer L.B., Zolna M.R. Shifts in intended and unintended pregnancies in the United States, 2001-2008. Am. J. Public Health. 2014; 104(Suppl. 1): S43-8. https://dx.doi.org/10.2105/AJPH.2013.301416.
Mosher W.D., Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat. 23. 2010; (29): 1-44.
Trussell J. Contraceptive failure in the United States. Contraception. 2011; 83(5): 397-404. https://dx.doi.org/10.1016/j.contraception.2011.01.021.
NICE. National Institute for Health and Care Excellence. Long-acting reversible contraception (LARC). Clinical guideline. 2005. Available at: https://www.nice.org.uk/guidance/cg30
ACOG Committee Opinion No. 735: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet. Gynecol. 2018; 131(5): e130-e139. https://dx.doi.org/10.1097/AOG.0000000000002632.
Committee Opinion No. 642: increasing access to contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet. Gynecol. 2015; 126(4): e44-e48. https://dx.doi.org/10.1097/AOG.0000000000001106.
Committee on Practice Bulletins-Gynecology, Long-Acting Reversible Contraception Work Group. Practice Bulletin No. 186: long-acting reversible contraception: implants and intrauterine devices. Obstet. Gynecol. 2017; 130(5): e251-e269. https://dx.doi.org/10.1097/AOG.0000000000002400.
Lohr P.A., Lyus R., Prager S. Use of intrauterine devices in nulliparous women. Contraception. 2017; 95(6): 529-37. https://dx.doi.org/10.1016/j.contraception.2016.08.011.
WНО Guidelines Approved by the Guidelines Review Committee. Medical eligibility criteria for contraceptive use. 5th ed. Geneva: World Health Organization; 2015.
Heinemann K., Reed S., Moehner S., Minh T.D. Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: The European Active Surveillance Study for Intrauterine Devices. Contraception. 2015; 91(4): 280-3. https://dx.doi.org/10.1016/j.contraception.2015.01.011.
Кузнецова И.В. Выбор комбинированной оральной контрацепции для подростков и молодых женщин. Акушерство и гинекология. 2018; 1: 35-40. [Kuznetsova I.V. Choice of combined oral contraception for adolescent girls and young women. Obstetrics and Gynecology. 2018; 1: 35-40. (in Russian)]. https://dx.doi.org/10.18565/aig.2018.1.35-40.
Довлетханова Э.Р., Мгерян А.Н., Абакарова П.Р. Вопросы приемлемости и безопасности при выборе комбинированных оральных контрацептивов. Акушерство и гинекология. 2019; 4: 79-86. [Dovletkhanova E.R., Mgeryan A.N., Abakarova P.R. Issues of acceptability and safety when choosing combined oral contraceptives. Obstetrics and Gynecology. 2019; 4: 79-86. (in Russian)]. https://dx.doi.org/10.18565/aig.2019.4.79-86.
Gemzell-Danielsson K., Apter D., Dermout S., Faustmann T., Rosen K., Schmelter T. et al. Evaluation of a new, low-dose levonorgestrel intrauterine contraceptive system over 5 years of use. Eur. J. Obstet. Gynecol. Reprod. Biol. 2017; 210: 22-8. https://dx.doi.org/10.1016/j.ejogrb.2016.11.022.
Hall A.M., Kutler B.A. Intrauterine contraception in nulliparous women: a prospective survey. J. Fam. Plann. Reprod. Health Care. 2016; 42(1): 36-42. https://dx.doi.org/10.1136/jfprhc-2014-101046.
Black A., Guilbert E., Costescu D., Dunn S., Fisher W., Kives S. et al. Canadian Contraception Consensus (Part 3 of 4): Chapter 7 - Intrauterine contraception. J. Obstet. Gynaecol. Can. 2016; 38(2): 182-222. https://dx.doi.org/10.1016/j.jogc.2015.12.002.
Аcсоциация организаций по клиническим исследованиям. Хельсинкская декларация Всемирной медицинской ассоциации. Принята на 18-й Генеральной Ассамблее ВМА, Хельсинки, Финляндия, июнь 1964 г., изменения внесены на 64-й Генеральной Ассамблее ВМА, Форталеза, Бразилия, октябрь 2013 г. [Association of Clinical Research Organizations. Helsinki Declaration of the World Medical Association. Adopted at the 18th General Assembly of the VMA, Helsinki, Finland, June 1964, changes were made at the 64th General Assembly of the VMA, Fortaleza, Brazil, October 2013. (in Russian)].
Федеральное агентство по техническому регулированию и метрологии. Национальный стандарт Российской Федерации. ГОСТ Р 52379-2005. Надлежащая клиническая практика. Официальное издание. М.: Стандартинформ; 2006. 39с. [National standard of the Russian Federation GOST R 52379-2005 "Good clinical practice". Federal Agency for Technical Regulation and Metrology. Official publication. M.: Standardized, 2006. 39 p. (in Russian)].
Nelson A.L., Apter D., Hauck B., Schmelter T., Rybowski S., Rosen K. et al. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet. Gynecol. 2013; 122(6): 1205-13. https://dx.doi.org/10.1097/AOG.0000000000000019.
Beatty M.N., Blumenthal P.D. The levonorgestrel-releasing intrauterine system: safety, efficacy, and patient acceptability. Ther. Clin. Risk Manag. 2009; 5(3): 561-74. https://dx.doi.org/10.2147/tcrm.s5624.
Gemzell-Danielsson K., Ink P., Heikinheimo O. Safety and efficacy of the levonorgestrel-releasing intrauterine system. Expert Rev. Obstet. Gynecol. 2013; 8(3): 235-47. https://dx.doi.org/10.1586/eog.13.18.
Borgatta L., Buhling K.J., Rybowski S., Roth K., Rosen K. A multicentre, open-label, randomized phase III study comparing a new levonorgestrel intrauterine contraceptive system (LNG-IUS 8) with combined oral contraception in young women of reproductive age. Eur. J. Contracept. Reprod. Health Care. 2016; 21(5): 372-9. https://dx.doi.org/10.1080/13625187.2016.1212987.
Прилепская В.Н., Абакарова П.Р., Межевитинова Е.А., Довлетханова Э.Р., Назарова Н.М. Современные принципы консультирования в контрацепции. Гормональная контрацепция. Акушерство и гинекология. 2021; 3(Приложение): 17-22. [Prilepskaya V.N., Abakarova P.R., Mezhevitinova E.A., Dovletkhanova E.R., Nazarova N.M. Modern principles of counseling in contraception. Hormonal contraception. Obstetrics and gynecology. 2021; 3 (Suppl): 17-22. (in Russian)].
Stephenson J., Shawe J., Panicker S., Brima N., Copas A., Sauer U. et al. Randomized trial of the effect of tailored versus standard use of the combined oral contraceptive pill on continuation rates at 1 year. Contraception. 2013; 88(4): 523-31. https://dx.doi.org/10.1016/j.contraception.2013.03.014.
Berenson A.B., Rahman M. A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms. Contraception. 2012; 86(6): 716-24. https://dx.doi.org/10.1016/j.contraception.2013.03.014.

Received 06.10.2021

Accepted 12.11.2021

Larisa V. Suturina, Dr. Med. Sci., Professor, Chief Researcher, Head of the Department of Reproductive Health Protection, Scientific Center for Family Health and Human Reproduction, Irkutsk, +7(3952)292207, Lsuturina@mail.ru, https://orcid.org/0000-0002-6271-7803, 664003, Russia, Irkutsk, Timiryazev str., 6, office 311.
Galina B. Dikke, Dr Med. Sci., Associate Professor, Professor of the Department of Obstetrics and Gynecology with a course of reproductive medicine, F.I. Inozemtsev Academy of Medical Education, St. Petersburg, +7(812)334-76-50, galadikke@yandex.ru, https://orcid.org/0000-0001-9524-8962,
190013, Russia, St. Petersburg, Moskovsky Ave., 22M.

Authors’ contributions: Suturina L.V. – main researcher of clinical studies No. BAY 86-5028/17878, writing the article;
Dikke G.B. – analysis of the results, writing the article.
Conflicts of interest: The authors declare that they have no competing interests.
Funding: The research was carried out within the framework of clinical studies No. BAY 86-5028/17878 (sponsored by Bayer AG, D-51368 Leverkusen, Germany).
Patients’ Consent to Publication: All patients provided informed consent for the publication of their data.
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: Suturina L.V., Dikke G.B. Experience in the use of low-dosed levonorgestrel-containing intrauterine system LCS16 and combined oral contraceptive containing 30 mcg ethinyl estradiol and 3 mg drospirenone in young women.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2021; 11: 230-236 (in Russian)
https://dx.doi.org/10.18565/aig.2021.11.230-236

Experience in the use of low-dosed levonorgestrel-containing intrauterine system LCS16 and combined oral contraceptive containing 30 mcg ethinyl estradiol and 3 mg drospirenone in young women

Suturina L.V., Dikke G.B.

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