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.
2015In European Journal of Contraception and Reproductive Health Care, 20 (6), p. 463-475
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Keywords :
Bone markers; Drospirenone; Endocrinology; Estetrol; Levonorgestrel; Lipid metabolism; Liver function; Article
Abstract :
[en] Objectives Estetrol (E<inf>4</inf>) is a natural estrogen produced by the human fetal liver. In combination with drospirenone (DRSP) or levonorgestrel (LNG), E<inf>4</inf> 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 E<inf>4</inf>/DRSP and E<inf>4</inf>/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 E<inf>4</inf>/3 mg DRSP; 5 mg, 10 mg or 20 mg E<inf>4</inf>/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 E<inf>4</inf>/DRSP and E<inf>4</inf>/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 E<inf>4</inf> groups, and the effects on triglycerides elicited by the E<inf>4</inf> 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 E<inf>4</inf> groups.Conclusions E<inf>4</inf>-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 :
20
Issue :
6
Pages :
463-475
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 15 February 2016

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