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A Phase I, Open-label, Randomized, Three-period, Crossover, Single-center Trial to Assess the Bioequivalence of the Co-administration of 900 IU of Follitropin Alfa (Gonal-f) and 450 IU of Lutropin Alfa (Luveris) Versus the Fixed Combination of 900 IU Follitropin Alfa and 450 IU Lutropin Alfa in Pergoveris, Administered SC as Liquid and FD Formulation, in Pituitary Suppressed Healthy Premenopausal Female Chinese Participants

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A Phase I, Open-label, Randomized, Three-period, Crossover, Single-center Trial to Assess the Bioequivalence of the Co-administration of 900 IU of Follitropin Alfa (Gonal-f) and 450 IU of Lutropin Alfa (Luveris) Versus the Fixed Combination of 900 IU Follitropin Alfa and 450 IU Lutropin Alfa in Pergoveris, Administered SC as Liquid and FD Formulation, in Pituitary Suppressed Healthy Premenopausal Female Chinese Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jun 2022

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At a glance

  • Drugs Follitropin alfa/lutropin alfa (Primary) ; Lutropin alfa (Primary) ; Follitropin alfa
  • Indications Female infertility
  • Focus Pharmacokinetics
  • Sponsors Merck KGaA

    • Most Recent Events

    • 14 Jun 2022 Status changed from recruiting to completed.
    • 21 Apr 2022 Planned End Date changed from 2 Feb 2022 to 20 May 2022.
    • 21 Apr 2022 Planned primary completion date changed from 2 Feb 2022 to 20 May 2022.
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