An Open-label, Randomized, Two-period, Two-sequence Crossover Trial to Assess the Bioequivalence of the Liquid Formulation Versus the Freeze-dried Formulation of 900 IU r-hFSH and 450 IU r-hLH in Pergoveris, Administered Subcutaneously in Pituitary Suppressed Healthy Premenopausal Female Subjects

Trial Profile

An Open-label, Randomized, Two-period, Two-sequence Crossover Trial to Assess the Bioequivalence of the Liquid Formulation Versus the Freeze-dried Formulation of 900 IU r-hFSH and 450 IU r-hLH in Pergoveris, Administered Subcutaneously in Pituitary Suppressed Healthy Premenopausal Female Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 16 Dec 2016

At a glance

  • Drugs Follitropin alfa/lutropin alfa (Primary)
  • Indications Female infertility
  • Focus Pharmacokinetics
  • Sponsors Merck KGaA
  • Most Recent Events

    • 07 Dec 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 12 Aug 2015 Planned End Date changed from 1 Jul 2015 to 1 Feb 2016, according to ClinicalTrials.gov record.
    • 12 Aug 2015 Planned primary completion date changed from 1 Jul 2015 to 1 Oct 2015, according to ClinicalTrials.gov record.
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