Universität zu Köln

Gemzell-Danielsson, Kristina, Cagnacci, Angelo ORCID: 0000-0003-2714-623X, Chabbert-Buffet, Nathalie, Douxfils, Jonathan ORCID: 0000-0002-7644-5298, Foidart, Jean-Michel, Kubba, Ali, Lete Lasa, Luis Ignacio, Mansour, Diana, Neulen, Joseph, Neves, Jaoquim, Palma, Fatima, Roemer, Thomas, Spaczynski, Robert ORCID: 0000-0002-4306-6590 and Toth, Vera (2022). A novel estetrol-containing combined oral contraceptive: European expert panel review. Eur. J. Contracept. Reprod. Health Care, 27 (5). S. 373 - 384. ABINGDON: TAYLOR & FRANCIS LTD. ISSN 1473-0782

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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 mu g/DRSP 3 mg and EE 30 mu g/levonorgestrel 150 mu g. 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Gemzell-Danielsson, Kristina UNSPECIFIED UNSPECIFIED UNSPECIFIED Cagnacci, Angelo UNSPECIFIED orcid.org/0000-0003-2714-623X UNSPECIFIED Chabbert-Buffet, Nathalie UNSPECIFIED UNSPECIFIED UNSPECIFIED Douxfils, Jonathan UNSPECIFIED orcid.org/0000-0002-7644-5298 UNSPECIFIED Foidart, Jean-Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Kubba, Ali UNSPECIFIED UNSPECIFIED UNSPECIFIED Lete Lasa, Luis Ignacio UNSPECIFIED UNSPECIFIED UNSPECIFIED Mansour, Diana UNSPECIFIED UNSPECIFIED UNSPECIFIED Neulen, Joseph UNSPECIFIED UNSPECIFIED UNSPECIFIED Neves, Jaoquim UNSPECIFIED UNSPECIFIED UNSPECIFIED Palma, Fatima UNSPECIFIED UNSPECIFIED UNSPECIFIED Roemer, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Spaczynski, Robert UNSPECIFIED orcid.org/0000-0002-4306-6590 UNSPECIFIED Toth, Vera UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-696521
DOI:	10.1080/13625187.2022.2093850
Journal or Publication Title:	Eur. J. Contracept. Reprod. Health Care
Volume:	27
Number:	5
Page Range:	S. 373 - 384
Date:	2022
Publisher:	TAYLOR & FRANCIS LTD
Place of Publication:	ABINGDON
ISSN:	1473-0782
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language BREAST-CANCER-CELLS; ESTRADIOL VALERATE/DIENOGEST; MU-G; HORMONAL CONTRACEPTIVES; OPEN-LABEL; SEXUAL FUNCTION; POOLED ANALYSIS; CYCLE CONTROL; DOUBLE-BLIND; PHASE-II Multiple languages Public, Environmental & Occupational Health; Obstetrics & Gynecology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69652