A novel estetrol-containing combined oral contraceptive: European expert panel review. (3rd September 2022)

• Record Type: Journal Article
• Authors: Gemzell-Danielsson, Kristina; Cagnacci, Angelo; Chabbert-Buffet, Nathalie; Douxfils, Jonathan; Foidart, Jean-Michel; Kubba, Ali; Lete Lasa, Luis Ignacio; Mansour, Diana; Neulen, Joseph; Neves, Jaoquim; Palma, Fátima; Römer, Thomas; Spaczyński, Robert; Tóth, Vera
• Is Part Of: European journal of contraception & reproductive health care. Volume 27:Number 5(2022)
• Page Start: 373
• Page End: 383
• Publication Date: 2022-09-03
• Subjects: Estetrol -- drospirenone -- combined oral contraceptive -- contraceptive efficacy -- bleeding pattern -- safety profile -- satisfaction; Contraception -- Periodicals; Reproductive health -- Periodicals; Generative organs, Female -- Periodicals; Contraception -- Periodicals; Reproductive Medicine -- Periodicals; 613.9
• DOI: 10.1080/13625187.2022.2093850
• Languages: English
• ISSNs: 1362-5187

Abstract

Abstract: 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 15 mg/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, well-being, 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 µg/DRSP 3 mg and EE 30 µg/levonorgestrel 150 µg. 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.