A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment.

Trial Profile

A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment.

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jul 2018

At a glance

  • Drugs Follitropin alfa (Primary)
  • Indications Infertility
  • Focus Registrational; Therapeutic Use
  • Sponsors FINOX
  • Most Recent Events

    • 10 Jul 2018 According to a Gedeon Richter media release, the European marketing authorisation (EMA) for BEMFOLA was supported by the data from this study.
    • 01 Mar 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 21 Nov 2012 New source identified and integrated (German Clinical Trials Register: DRKS00004132).
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