Mithra announces completion of recruitment in pediatric study of Estelle in adolescent patients

Developed by Mithra, Estelle is the first and only contraceptive pill containing Estetrol (E4), the only estrogen native to human pregnancy. The objective of the pediatric study (MIT-Es001-C303, ClinicalTrials.gov: NCT04792385, EudraCT: 2019-003002-27) is to evaluate the safety, compliance, and pharmacokinetics profile of Estelle (estetrol monohydrate 15 mg and drospirenone 3 mg) in 100 participants aged 12 to 17 years old, as agreed with regulatory authorities. The study is being conducted in a number of European countries (Estonia, Finland, Georgia, Latvia, Poland, Sweden).

Graham Dixon, Chief Scientific Officer of Mithra, commented: « The completion of recruitment for this pediatric study represents an important milestone in our commitment to bringing Estelle to a wider patient population. We look forward to reporting data from this trial in 2024 and expanding the body of scientific data available to clinicians to support their decision-making. »

Professor Kristina Gemzell-Danielsson, Chair of Obstetrics and Gynecology and Head of the Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden, commented: « Combined Oral Contraceptives such as Estelle are the most popular hormonal contraceptives (1) in the adolescent population, and adolescents are more likely than adult women to use these products for health purposes other than birth control such as cycle and bleeding control (2). Despite widespread use in adolescents, clinical data from this population is limited. Studies such as this one are needed in order to bring safe and effective contraceptives to those that need it most. »

(1) Todd N and Black A Contraception for Adolescents J Clin Res Pediatr Endocrinol 2020;12(Suppl 1):28-40

(2) Jones RK. Beyond birth control: the overlooked benefits of oral contraceptive pills. New York, NY: Guttmacher Institute; 2011