Open-label, Single-arm, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of COL-1620 8% Vaginal Progesterone Gel for Luteal Phase Support in In-vitro Fertilization and Embryo Transfer (IVF/ET) Cycles in Japanese Women

Trial Profile

Open-label, Single-arm, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of COL-1620 8% Vaginal Progesterone Gel for Luteal Phase Support in In-vitro Fertilization and Embryo Transfer (IVF/ET) Cycles in Japanese Women

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jul 2016

At a glance

  • Drugs Progesterone (Primary) ; Chorionic gonadotropin; Follicle stimulating hormones; Gonadotropin releasing hormone modulators
  • Indications Infertility
  • Focus Therapeutic Use
  • Sponsors Merck KGaA
  • Most Recent Events

    • 05 Jul 2016 According to Juniper Pharmaceuticals media release, the company has announced the company has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for OneCrinone 90 mg (progesterone) for the indication of luteal phase supplementation in assisted reproductive treatment.
    • 24 Nov 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 07 Jul 2014 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.
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