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

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2017

At a glance

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

    • 27 Nov 2017 According to the Ferring Pharmaceuticals media release, based on the data from ESTHER programme, Swissmedic has approved Rekovelle(follitropin delta) for use in controlled stimulation for induction of the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).
    • 06 Feb 2017 Status changed from active, no longer recruiting to completed.
    • 25 Jan 2017 This trial has been completed in Italy as per European Clinical Trials Database record.
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