Estelle® study results published in leading peer-reviewed medical journal
Mithra, a company dedicated to Women’s Health, announces the publication of a scientific paper entitled “Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone” in Contraception Journal, one of the most prestigious peer-reviewed journals in the field. A link to this publication can be accessed here.
This scientific paper highlights the limited effects of a new combined oral contraceptive (COC) containing Estetrol (E4) and Drospirenone (DRSP) - namely the Estelle® product candidate developed by Mithra - on endocrine and metabolic parameters in a comparative study with the two frequently used COC’s based on Ethinylestradiol (EE): one combined with Levonorgestrel and the other with Drospirenone, to validate changes related to the estrogen source. Currently, about 97% of marketed combined oral contraceptives are based on the synthetic estrogen Ethinylestradiol.
The results of this study confirm previous observations that Estelle® has a minimal impact on liver proteins, lipid profile, carbohydrate metabolism, cortisol and gonadotropins. The effects on liver proteins, triglycerides and endocrine parameters such as cortisol were less pronounced compared to Ethinylestradiol-based products. This profile is supported by the unique mode of action of Estetrol, which is a native estrogen produced by the foetus during pregnancy and acting selectively in tissues.
Graham Dixon, CSO Mithra Women’s Health, commented: “We are very pleased that the positive results from this comparative study on our product candidate Estelle® have been published in one of the most prestigious and well-respected scientific journals, that serves as a reference in the medical sphere. This article highlights that Estelle® could really offer women a promising new contraceptive solution, with a number of advantages over current COCs pills. We look forward to the feedback of regulatory agencies in the United States, Europe and Canada, with marketing authorization in the first half of this year.”