A novel estetrol-containing combined oral contraceptive: European expert panel review

Česká verzia

Authors: Kristina Gemzell-Danielsson ¹; Angelo Cagnacci ²; Nathalie Chabbert-Buffet ³; Jonathan Douxfils ⁴; Jean-Michel Foidart ⁵; Ali Kubba ⁶; Luis Ignacio Lete Lasa ⁷; Diana Mansour ⁸; Joseph Neulen ⁹; Jaoquim Neves ¹⁰; Fátima Palma ¹¹; Thomas Römer ¹²; Robert Spaczy Ski ¹³; Vera Tóth ¹⁴
Authors place of work: Department of Women’s and Children’s Health, Karolinska Institutet and Karolinska University Hospital Solna, Stockholm, Sweden ¹; IRCCS-Policlinic Hospital San Martino, Obstetrics and Gynecology Unit, University of Genoa, DINOGMI, Genoa, Italy ²; Service de gynécologie obstétrique, médecine de la reproduction, APHP Sorbonne Université, Site Tenon, Paris, France ³; Department of Pharmacy, Namur Thrombosis and Hemostasis Center, Namur Research Institute for LIfe Sciences, University of Namur, Namur, Belgium, Qualiblood s. a., Namur, Belgium ⁴; Estetra SRL, an affiliate company of Mithra Pharmaceuticals, University of Liège, Liège, Belgium ⁵; Department of Obstetrics And Gynaecology, Guy’s and St Thomas’ NHS Foundation Trust, London, UK ⁶; Obstetrics and Gynecology Clinical Management Unit, Araba University Hospital, Vitoria, Spain ⁷; Department of Obstetrics And Gynaecology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK ⁸; Klinik für Gynäkologische Endokrinologie und Reproduktionsmedizin, RWTH Aachen, Aachen, Germany ⁹; Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal ¹⁰; Department of Obstetrics, Maternidade Alfredo da Costa, Centro Hospitalar Universiário Lisboa Central, Lisbon, Portugal ¹¹; Department of Obstetrics and Gynecology, Academic Hospital of Obstetrics and Gynecology, University of Cologne, Cologne, Germany ¹²; Klinika Niepłodności I Endokrynologii Rozrodu Uniwersytet Medyczny im. Karola Marcinkowskiego ul, Polna, Poznań, Poland ¹³; Medical Information Scientifi c Service, Gedeon Richter Plc, Budapest, Hungary ¹⁴
Published in the journal: Ceska Gynekol 2022; 87(6): 440-452
Category:
doi: https://doi.org/10.1080/ 13625187.2022.2093850

Summary

Purpose: Despite considerable advances in recently developed combined oral contraceptives (COCs), resulting in lower rates of adverse events while maintaining contraceptive efficacy, there is interest in further innovation. Materials and Methods: Estetrol (E4), a native oestrogen, and progestin drospirenone (DRSP) were combined in a new COC. A European expert panel reviewed the pharmacology, efficacy, and safety and tolerability of this combination. Their findings are presented as a narrative review. Results: E4 15mg/DRSP 3 mg in a 24/4 regimen provided effective contraception with good cycle control, characterised by a predictable regular bleeding pattern and minimal unscheduled bleeding, together with a good safety profile. The combination was associated with high user satisfaction, wellbeing, and minimal changes in body weight. The effects on endocrine and metabolic parameters were limited, and the combination was found to have a limited impact on liver function and lipid and carbohydrate metabolism. Moreover, its effect on several haemostatic parameters was lower than that of comparators containing ethinyl oestradiol (EE) 20 mg/DRSP 3 mg and EE 30 mg/levonorgestrel 150 mg. Conclusion: E4 15 mg/DRSP 3 mg provides safe and effective contraception, with high user satisfaction and predictable bleeding. Further research will evaluate the long-term safety of the COC.

Keywords:

efficacy – drospirenone – estetrol – satisfaction – combined oral contraceptive – contraceptive – bleeding pattern – safety profile

Article was adopted from: Eur J Contracept Reprod Health Care 2022; 27(5): 373–383. doi: 10.1080/13625187.2022.2093850

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