Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that the European Journal of Contraception and Reproductive Health Care, one of the most prestigious peer-reviewed journals in the field, has published an article1 detailing the acceptability, user satisfaction, well-being and body weight control of Estelle® in the Phase IIb FIESTA study. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Estelle® is currently being tested in two Phase III trials in Europe/Russia and in the US/Canada, the results of which should be available in Q3 2018 and Q1 2019, respectively.
The article reports on a number of secondary endpoints of the FIESTA study, which are key to the eventual user acceptability of Estelle®. User satisfaction and well-being were evaluated by a selfreported Subject Satisfaction and Health-related Questionnaire, which assessed parameters including the effect of the study medication on mood, sexual life and pre-menstrual symptoms. Estelle® (15 mg E4/DRSP) reported the highest treatment satisfaction, above both E4/levonorgestrel (LNG) doses, the 20 mg E4/DRSP dose and the Qlaira® reference group. Well-being was significantly higher for the E4/DRSP doses compared to E4/LNG, and was comparable to Qlaira®. Estelle® had the lowest dropout rate of the five treatment groups.
With regard to body weight, the proportion of women with weight loss of 2 kg or more after 3 andn 6 cycles was highest in the Estelle® group. Weight gain is considered an important and common reason for treatment discontinuation of COCs2. Therefore, the favorable weight control profile observed in the FIESTA study could potentially be an important advantage of Estelle®, as it could play a role in treatment compliance and continuation.
François Fornieri, CEO of Mithra, commented: “We are very pleased that the positive results from the FIESTA study with our novel compound Estelle® have been published in a well-respected, peer-reviewed journal. The data highlight that Estelle® could offer women a number of advantages over current COCs. Furthermore, the article reinforces the need for an innovative, improved COC for women and is validation of the scientific community’s support for Estelle’s® potential. We are looking forward to the results of the Phase III trials of Estelle®: we expect continued demonstration that Estelle® is strongly differentiated from current COCs, as it has the potential to combine an improved safety profile with high user acceptance, satisfaction, and good body weight control.”