Preview

Bulletin of Reproductive Health

Advanced search

Satisfaction of young women with estradiol valerate/dienogest in real clinical practice in Russia: results of prospective multicenter observational study Q-SWAN

https://doi.org/10.14341/brh12748

Abstract

BACKGROUND: E2V/DNG is widely use in Russian clinical practice, although satisfaction of Russian patients and doctors has not been ever evaluated and analysed.
AIM: To evaluate satisfaction in young women (18–35 years old) with a drug containing estradiol valerate/dienogest (E2V/ DNG) over a 6-month period in real clinical practice in Russia.
MATERIALS AND METHODS: This was a prospective multicenter study (Q-SWAN – Qlaira, Satisfaction, WomAN [ClinicalTrials. gov: NCT04901377]) that assessed satisfaction of 504 women (average age is 27.8 years) with the contraceptive containing E2V/DNG. The characteristics of menstrual bleeding, sexual function, women’s decision to continue and satisfaction of doctors with this method of contraception were also assessed.
RESULTS: It was found that 98.4% of women and 100% of doctors were “very satisfied” or “satisfied” with this method of contraception, regardless of the presence or absence of AUB. There was a significant decrease in the intensity, duration of menstrual bleeding and pain. Normalization of the parameters of the FSFI questionnaire was observed in most of the patients (89.7%). The contraceptive E2V/DNG was well tolerated by women, and the overall rate of adverse events was 7.1%. Most women (97.8%) decided to continue taking the medication after completing the study.
CONCLUSION: The results of the study showed high satisfaction of young Russian women and doctors with the use of E2V/DNG, regardless of the presence or absence of AUB. The medication has a positive effect on the characteristics of bleeding/ cycle control and on the quality of sexual function, therefore, the women demonstrated a high adherence to this method of contraception.

About the Authors

V. N. Prilepskaya
Academician V.I. Kulakov National Medical Research Centre for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health
Russian Federation

Vera G. Prilepskaya, MD, Doctor of Sciences, Professor

Moscow


Competing Interests:

АО «Байер», как спонсор исследования, было вовлечено в разработку дизайна, сбор и анализ данных исследования, согласно предварительно установленному плану статистического анализа. Авторы, подготовившие статью, имели неограниченный доступ ко всем данным по исследованию, соответствуют всем критериям авторства ICMJE и ручаются за точность и полноту представленных ими аналитических результатов.



E. N. Andreeva
National Medical Research Center for Endocrinology, Ministry of Health of Russia; Russian University of Medicine, Ministry of Health of Russia
Russian Federation

Elena N. Andreeva, MD, Doctor of Sciences, Professor

11 Dm.Ulyanova street, 117036 Moscow


Competing Interests:

АО «Байер», как спонсор исследования, было вовлечено в разработку дизайна, сбор и анализ данных исследования, согласно предварительно установленному плану статистического анализа. Авторы, подготовившие статью, имели неограниченный доступ ко всем данным по исследованию, соответствуют всем критериям авторства ICMJE и ручаются за точность и полноту представленных ими аналитических результатов.



References

1. Dikke GB. Needs, expectations and doubt users of hormonal contraceptives. Gynecology. 2020;22(1):33‑7. (in Russian). doi: https://dx.doi.org/10.26442/20795696.2020.1.200044

2. Sheremetyeva EV, Andreeva EN. Individualized contraceptive counseling for young women in clinical practice. Russian Journal of Human Reproduction. 2022;28(4):89‑96. (in Russian) doi: https://dx.doi.org/10.17116/repro20222804189

3. Nappi RE, Vermuyten N, Bannemerschult R. Missed opportunities in contraceptive counselling: findings from a European survey‑based study with simulated patient consultation. Eur. J. Contracept. Reprod. Health Care. 2022;27(2):85‑94. doi: https://dx.doi.org/10.1080/13625187.2021.2010040

4. Bitzer J, Marin V, Lira J. Contraceptive counselling and care: a personalized interactive approach. Eur. J. Contracept. Reprod. Health Care. 2017;22(6):418‑23. doi: https://dx.doi.org/10.1080/13625187.2017.1414793

5. Cavallaro FL, Benova L, Owolabi OO, Ali M. A systematic review of the effectiveness of counselling strategies for modern contraceptive methods: what works and what doesn’t? BMJ Sex. Reprod. Health. 2020;46(4):254‑69. https:// dx.doi.org/10.1136/bmjsrh‑2019‑200377

6. FSRH Clinical Effectiveness Unit. FSRH clinical guideline: combined hormonal contraception (January 2019, Amended October 2023). doi: https:// dx.doi.org/10.1136/bmjsrh‑2018‑CHC

7. Prilepskaya VN, Abakarova PR, Yarotskaya YeL. Modern Contraception and Women’s Quality of Life. Doctor.Ru. 2017;(3): 37‑42. (in Russian)

8. Dikke GB. Failure from the previously selected method of contraception and strategy for improving commitment. Russian Journal of Human Reproduction. 2017;23(5):54‑60. (in Russian). doi: https://dx.doi.org/10.17116/ repro201723554‑60

9. Le Guen M, Schantz C, Règnier-Loilier A, de La Rochebrochard E. Reasons for rejecting hormonal contraception in Western countries: A systematic review. Soc. Sci. Med. 2021;284:114247. doi: https://dx.doi.org/10.1016/j.socscimed.2021.114247

10. Graziottin A. The shorter, the better: a review of the evidence for a shorter contraceptive hormone‑free interval. Eur. J. Contracept. Reprod. Health Care. 2016;21(2):93‑105. doi: https://dx.doi.org/10.3109/13625187.2015.1077380

11. Andreeva EN, Sheremetyeva EV. Contraception modes: increasing women’s commitment to modern combined oral contraceptives with the shortest possible hormone‑free interval. Gynecology. 2020;22(2):46‑50. (in Russian). doi: https://dx.doi.org/10.26442/20795696.2020.2.200128

12. The current version of the instructions of the drug Qlaira dated 05/31/2023. RU number: LP‑No. (002448)‑(RG‑RU). (in Russian)

13. Nelson A, Parke S, Mellinger U, Zampaglione E, Schmidt A. Efficacy and safety of a combined oral contraceptive containing estradiol valerate/ dienogest: results from a clinical study conducted in North America. J. Womens Health (Larchmt). 2014;23(3):204‑10. doi: https://dx.doi.org/10.1089/jwh.2013.4320

14. Contraceptive efficacy and safety of estradiol valerate/dienogest in a healthy female population: a multicenter, open‑label, uncontrolled Phase III study. Int. J. Womens Health. 2018;10:257‑66. doi: https://dx.doi.org/10.2147/IJWH.S157056

15. Petraglia F, Parke S, Serrani M, Mellinger U, Römer T. Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea. Int. J. Gynaecol. Obstet. 2014;125(3):270‑4. doi: https://dx.doi.org/10.1016/j.ijgo.2013.11.017

16. Macìas G, Merki-Feld GS, Parke S, Mellinger U, Serrani M. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal‑associated symptoms: results from the multicentre, randomised, double‑blind, active‑controlled HARMONY II study. J. Obstet. Gynaecol. 2013;33(6):591‑6. doi: https://dx.doi.org/10.3109/01443615.2013.800851

17. Dinger J, Möhner S, Heinemann K. Combined oral contraceptives containing dienogest and estradiol valerate may carry a lower risk of venous and arterial thromboembolism compared to conventional preparations: Results from the extended INAS‑SCORE study. Front. Womens Health. 2020;5:1‑8. doi:https:// dx.doi.org/10.15761/FWH.1000178

18. Ahrendt HJ, Makalová D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol‑based oral contraceptive: a seven‑cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009;80(5):436‑44. doi:https://dx.doi.org/10.1016/j.contraception.2009.03.018

19. Fraser IS, Parke S, Mellinger U, Machlitt A, Serrani M, Jensen J. Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double‑blind, placebo‑ controlled trials of oestradiol valerate and dienogest. Eur. J. Contracept. Reprod. Health Care. 2011;16(4):258‑69. doi: https://dx.doi.org/10.3109/13625187.2011.591456

20. Haverinen AH, Luiro KM, Szanto T, Kangasniemi MH, Hiltunen L, Sainio S, et al. Combined oral contraceptives containing estradiol valerate vs ethinylestradiol on coagulation: A randomized clinical trial. Acta Obstet. Gynecol. Scand. 2022;101(10):1102‑11. doi: https://dx.doi.org/10.1111/aogs.14428

21. Meston CM, Freihart BK, Handy AB, Kilimnik CD, Rosen RC. Scoring and interpretation of the FSFI: What can be learned from 20 years of use? J. Sex. Med. 2020;17(1):17‑25. doi: https://dx.doi.org/10.1016/j.jsxm.2019.10.007

22. Briggs P, Serrani M, Vogtländer K, Parke S. Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen‑only pill after switching from an ethinylestradiol‑containing pill in a real‑life setting: results of the CONTENT study. Int. J. Womens Health. 2016;8:477‑87. doi: https://dx.doi.org/10.2147/IJWH.S107586

23. Barnett C, Dinger J, Minh TD, Heinemann K. Unintended pregnancy rates differ according to combined oral contraceptive – results from the INAS‑ SCORE study. Eur. J. Contracept. Reprod. Health Care. 2019;24(4):247‑50. doi: https://dx.doi.org/10.1080/13625187.2019.1629412

24. Prilepskaya VN, Dovletkhanova ER. Hormonal сontraception using a combined oral contraceptive containing estradiol valerate/dienogest. Medical. Opponent. 2022;(2):46-52. (in Russian)

25. Young MF, Oaks BM, Tandon S, Martorell R, Dewey KG, Wendt AS. Maternal hemoglobin concentrations across pregnancy and maternal and child health: a systematic review and meta-analysis. Ann. N. Y. Acad. Sci. 2019;1450(1):47-68. doi: https://dx.doi.org/10.1111/nyas.14093

26. Kutsenko II, Kravtsova EI, Kholina LA, Tomina OV. Latent iron deficiency therapy in pregnant women. Gynecology. 2022;24(6):512-7. (in Russian). doi: https://dx.doi.org/10.26442/20795696.2022.6.202023

27. Jensen JT, Bitzer J, Nappi RE, Ahlers C, Bannemerschult R, Parke S. Pooled analysis of bleeding profile, efficacy and safety of oral oestradiol valerate/dienogest in women aged 25 and under. Eur. J. Contracept. Reprod. Health Care. 2020;25(2):98-105. doi: https://dx.doi.org/10.1080/13625187.2020.1731734

28. Palacios S, Wildt L, Parke S, Machlitt A, Romer T, Bitzer J. Efficacy and safety of a novel oral contraceptive based on oestradiol (oestradiol valerate/dienogest): a Phase III trial. Eur. J. Obstet. Gynecol. Reprod. Biol. 2010;149(1):57-62. doi:https://dx.doi.org/10.1016/j.ejogrb.2009.11.001

29. Davis SR, Bitzer J, Giraldi A, Palacios S, Parke S, Serrani M, et al. Change to either a nonandrogenic or androgenic progestincontaining oral contraceptive preparation is associated with improved sexual function in women with oral contraceptiveassociated sexual dysfunction. J. Sex. Med. 2013;10(12):3069-79. doi: https://dx.doi.org/10.1111/jsm.12310

30. Caruso S, Agnello C, Romano M, Cianci S, Lo Presti L, Malandrino C, Cianci A. Preliminary study on the effect of four-phasic estradiol valerate and dienogest (E2V/DNG) oral contraceptive on the quality of sexual life. J. Sex. Med. 2011;8(10):2841-50. doi: https://dx.doi.org/10.1111/j.1743-6109.2011.02409.x

31. De Seta F, Restaino S, Banco R, Conversano ., De Leo R, Tonon M, et al. Effects of estroprogestins containing natural estrogen on vaginal flora. Gynecol. Endocrinol. 2014;30(11):830-5. doi: https://dx.doi.org/10.3109/09513590.2014.936847

32. Di Carlo C, Gargano V, De Rosa N, Tommaselli GA, Sparice S, Nappi C. Effects of estradiol valerate and dienogest on quality of life and sexual function according to age. Gynecol. Endocrinol. 2014;30(12):925-8. doi: https://dx.doi.org/10.3109/09513590.2014.975688

33. Yureneva SV, Ilina LM. Combined oral contraceptives with natural estrogen and sexual function: the optimal method of contraception for women of different ages. Gynecology. 2019;21(1):33-7. (in Russian). doi: https://dx.doi.org/10.26442/20795696.2019.1.190184

34. de Castro Coelho F, Barros C. The potential of hormonal contraception to influence female sexuality. Int. J. Reprod. Med. 2019;2019:9701384. doi: https://dx.doi.org/10.1155/2019/9701384


Review

For citations:


Prilepskaya V.N., Andreeva E.N. Satisfaction of young women with estradiol valerate/dienogest in real clinical practice in Russia: results of prospective multicenter observational study Q-SWAN. Bulletin of Reproductive Health. 2024;(4):4-13. (In Russ.) https://doi.org/10.14341/brh12748

Views: 118


ISSN 2075-6569 (Print)
ISSN 2310-421X (Online)