Unique effects on hepatic function, lipid metabolism, bone and growth endocrine parameters of estetrol in combined oral contraceptives

Mawet, Marie; Maillard, C.; Klipping, C.; Zimmerman, Y.; Foidart, Jean-Michel; Bennink, H. J. T. C.

doi:10.3109/13625187.2015.1068934

Article (Scientific journals)

Unique effects on hepatic function, lipid metabolism, bone and growth endocrine parameters of estetrol in combined oral contraceptives

Mawet, Marie; Maillard, C.; Klipping, C. et al.

2015 • In European Journal of Contraception and Reproductive Health Care, 20 (6), p. 463-475

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/193296

DOI
10.3109/13625187.2015.1068934

PubMed
26212489

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Keywords :

Bone markers; Drospirenone; Endocrinology; Estetrol; Levonorgestrel; Lipid metabolism; Liver function; Article

Abstract :

[en] Objectives Estetrol (E4) is a natural estrogen produced by the human fetal liver. In combination with drospirenone (DRSP) or levonorgestrel (LNG), E4 blocks ovulation and has less effect on haemostatic biomarkers in comparison with ethinylestradiol (EE) combined with DRSP. This study evaluates the impact of several doses of E4/DRSP and E4/LNG on safety parameters such as liver function, lipid metabolism, bone markers and growth endocrine parameters.Methods This was a dose-finding, single-centre, controlled study performed in healthy women aged 18 to 35 years with a documented pretreatment ovulatory cycle. Participants received 5 mg or 10 mg E4/3 mg DRSP; 5 mg, 10 mg or 20 mg E4/150 g LNG; or 20 g EE/3 mg DRSP as a comparator for three consecutive cycles in a 24/4-day regimen. Changes from baseline to end of treatment in liver parameters, lipid metabolism, bone markers and growth endocrinology were evaluated.Results A total of 109 women were included in the study. Carrier proteins were minimally affected in the E4/DRSP and E4/LNG groups, in comparison with the EE/DRSP group, where a significant increase in sex hormone-binding globulin was observed. Similarly, minor effects on lipoproteins were observed in the E4 groups, and the effects on triglycerides elicited by the E4 groups were significantly lower than those in the EE/DRSP group. No imbalances in bone markers were observed in any groups. No alterations in insulin-like growth factor were observed in the E4 groups.Conclusions E4-containing combinations have a limited effect on liver function, lipid metabolism, and bone and growth endocrine parameters. © 2015 The European Society of Contraception and Reproductive Health.

Disciplines :

Reproductive medicine (gynecology, andrology, obstetrics)

Author, co-author :

Mawet, Marie ; Estetra SPRL, Rue Saint Georges 5-7, Liège, Belgium

Maillard, C.; Estetra SPRL, Rue Saint Georges 5-7, Liège, Belgium

Klipping, C.; Dinox BV, Groningen, Netherlands

Zimmerman, Y.; Pantarhei Bioscience BV, Zeist, Netherlands

Foidart, Jean-Michel ; Université de Liège > Département des sciences cliniques > Département des sciences cliniques

Bennink, H. J. T. C.; Pantarhei Bioscience BV, Zeist, Netherlands

Language :

English

Title :

Unique effects on hepatic function, lipid metabolism, bone and growth endocrine parameters of estetrol in combined oral contraceptives

Publication date :

2015

Journal title :

European Journal of Contraception and Reproductive Health Care

ISSN :

1362-5187

eISSN :

1473-0782

Publisher :

Parthenon Publishing Group, Carnforth, United Kingdom

Volume :

Issue :

Pages :

463-475

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 15 February 2016

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