Mithra Announces First Subject Completes Estelle® Phase III Study

  • Estelle® Phase III studies remain on track to report top line results in Q3 2018 and Q1 2019 in Europe/Russia and the US/Canada respectively

Liège, Belgium, 18 August 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that the first European study subject has successfully completed 13 cycles of Estelle® and the end of study physician visit in the E4 Freedom Phase III study program. 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.

Recruitment Completed in Estelle® Population PK Substudy

  • Study to determine impact of demographic characteristics on the absorption, distribution and excretion of Estelle®
  • PK study is part of the Estelle® Phase III program in the US/Canada, which remains on track to report top line results in Q1 2019

Liège, Belgium, 09 August 2017– Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that it has completed recruitment in the population PK substudy for Estelle®. This trial is part of the Estelle® Phase III E4 Freedom program currently ongoing in Europe/Russia and in the US/Canada, with results expected in Q3 2018 and Q1 2019, respectively. Estelle® is Mithra’s combined oral contraceptive (COC) candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).