Open-Label, Parallel-Group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 mcg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Human Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-Ovulation Secondary to Hypothalamic-Pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa

Trial Profile

Open-Label, Parallel-Group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 mcg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Human Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-Ovulation Secondary to Hypothalamic-Pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2016

At a glance

  • Drugs MSJ 0011 (Primary) ; Chorionic gonadotropin
  • Indications Anovulation; Ovulation disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Merck KGaA
  • Most Recent Events

    • 26 Jun 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 23 Nov 2014 According to the ClinicalTrials.gov record, planned end date changed from 1 Dec 2014 to 1 Jan 2015.
    • 23 Nov 2014 According to the ClinicalTrials.gov record, status changed from recruiting to active, no longer recruiting.
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