Mithra Announces Positive Top-Line Results of Estelle® Phase III Oral Contraceptive Study in EU/Russia

  • Primary efficacy endpoint indicates excellent contraceptive efficacy, with a Pearl Index (PI) of 0.48 per 100 women, exceeding efficacy goals
  • Key secondary endpoints achieved, including outstanding bleeding profile, cycle control, quality of life and safety and tolerability
  • Estelle® Phase III stsudy in US/Canada on track to report top-line results in Q1 2019
  • Data further support Estelle® as a novel, next-generation combined oral contraceptive for women

Liège, Belgium, 8 August 2018, 07:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that its Phase III Estelle® study conducted in Europe and Russia successfully met its primary efficacy endpoint. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.