|Trade names||Nextstellis, others|
|Other names||E4/DRSP; FSN-013|
Drospirenone/estetrol, sold under the brand name Nextstellis among others, is a fixed-dose combination medication containing drospirenone, a progestin, and estetrol, an estrogen, which is used as a combined birth control pill for the prevention of pregnancy in women. It is taken by mouth.
Estetrol-containing birth control pills, similarly to estradiol-containing birth control pills, may have a lower risk of venous thromboembolism (VTE) than ethinylestradiol-containing birth control pills based on studies of coagulation. However, it is likely that another decade will be required before post-marketing epidemiological studies of VTE incidence with these birth control pills are completed and able to confirm this.
Drospirenone/estetrol has a much lower impact on liver protein synthesis, including of sex hormone-binding globulin, angiotensinogen, and coagulation factors, than does ethinylestradiol/drospirenone.
Society and culture
- Birth control pill formulations
- List of combined sex-hormonal preparations § Estrogens and progestogens
- "Nextstellis". Therapeutic Goods Administration (TGA). 6 December 2021. Retrieved 28 December 2021.
- https://pdf.hres.ca/dpd_pm/00060352.PDF[bare URL PDF]
- "Nextstellis Product information". Health Canada. 25 April 2012. Retrieved 4 November 2021.
- "Summary Basis of Decision (SBD) for Nextstellis". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- "Nextstellis- drospirenone and estetrol kit". DailyMed. Retrieved 1 June 2021.
- "Drovelis EPAR". European Medicines Agency (EMA). Retrieved 4 November 2021.
- "Lydisilka EPAR". European Medicines Agency (EMA). Retrieved 4 November 2021.
- Morimont L, Haguet H, Dogné JM, Gaspard U, Douxfils J (2021). "Combined Oral Contraceptives and Venous Thromboembolism: Review and Perspective to Mitigate the Risk". Front Endocrinol (Lausanne). 12: 769187. doi:10.3389/fendo.2021.769187. PMC 8697849. PMID 34956081.
- Douxfils J, Morimont L, Bouvy C (November 2020). "Oral Contraceptives and Venous Thromboembolism: Focus on Testing that May Enable Prediction and Assessment of the Risk". Semin Thromb Hemost. 46 (8): 872–886. doi:10.1055/s-0040-1714140. PMID 33080636. S2CID 224821517.
- Grandi G, Facchinetti F, Bitzer J (February 2022). "Confirmation of the safety of combined oral contraceptives containing oestradiol on the risk of venous thromboembolism". Eur J Contracept Reprod Health Care. 27 (2): 83–84. doi:10.1080/13625187.2022.2029397. PMID 35133236. S2CID 246651102.
Moreover, the introduction of other new natural oestrogenic components, such as estetrol (E4) , could have a similar lower VTE impact; however, we will likely need another decade to obtain results from post-marketing studies.
- Farris M, Bastianelli C, Rosato E, Brosens I, Benagiano G (October 2017). "Pharmacodynamics of combined estrogen-progestin oral contraceptives: 2. effects on hemostasis". Expert Rev Clin Pharmacol. 10 (10): 1129–1144. doi:10.1080/17512433.2017.1356718. PMID 28712325. S2CID 205931204.
- "Drug Approval Package: Nextstellis". U.S. Food & Drug Administration (FDA). 12 May 2021. Retrieved 30 November 2021.
- "Drospirenone". Drug Information Portal. U.S. National Library of Medicine.
- "Estetrol". Drug Information Portal. U.S. National Library of Medicine.
- Clinical trial number NCT02817828 for "E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study" at ClinicalTrials.gov
- Clinical trial number NCT02817841 for "E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study" at ClinicalTrials.gov