F-16 schreef op 3 mei 2018 07:41:
Press Release
Mithra Announces Last Subject Visit in Estelle® Phase III Study in EU/Russia and Completion of Endometrial Substudy
3 May 2018
Estelle® Phase III studies remain on track to report top-line results in Q3 2018 from Europe/Russia and Q1 2019 from US/Canada
Endometrial safety substudy expected to report results in Q3 2018
Liège, Belgium, 3 May 2018 – 7:30 AM – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the last subject in the European/Russian Phase III Estelle® study has now completed her last study visit. Mithra also announces that the endometrial safety substudy has completed recruitment. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP), and is currently being tested in two Phase III trials in Europe/Russia and in the US/Canada.