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A randomised, controlled, assessor-blind, parallel groups, multicentre, multinational trial comparing the efficacy and safety of FE 999049 with follitropin alfa (GONAL-F) in controlled ovarian stimulation in women undergoing an assisted reproductive technology programme

Trial Profile

A randomised, controlled, assessor-blind, parallel groups, multicentre, multinational trial comparing the efficacy and safety of FE 999049 with follitropin alfa (GONAL-F) in controlled ovarian stimulation in women undergoing an assisted reproductive technology programme

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2018

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At a glance

  • Drugs Follitropin delta (Primary) ; Follitropin alfa
  • Indications Female infertility
  • Focus Registrational; Therapeutic Use
  • Acronyms ESTHER-1
  • Sponsors Ferring Pharmaceuticals
  • Most Recent Events

    • 29 Oct 2018 According to the Ferring Pharmaceuticals media release, based on the results of this study, REKOVELLE (follitropin delta injection) is now available in Canada for women undergoing assisted reproductive technologies such as in vitro fertilization (IVF).
    • 10 Oct 2018 Results of a pooled analysis assessing the neonatal outcome and incidence of congenital malformations following treatment with follitropin delta in phase III studies (ESTHER-1 and -2) presented at the American Society for Reproductive Medicine Scientific Congress 2018
    • 02 Jul 2018 Results published in the Ferring Pharmaceuticals Media Release
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