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A Multi-Center, Randomized, Open-Label Study Comparing Bioavailability When Preservative-free Makena (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women

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Trial Profile

A Multi-Center, Randomized, Open-Label Study Comparing Bioavailability When Preservative-free Makena (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Hydroxyprogesterone (Primary) ; Hydroxyprogesterone
  • Indications Preterm labour
  • Focus Pharmacokinetics; Registrational
  • Sponsors AMAG Pharmaceuticals

    • Most Recent Events

    • 27 Nov 2017 Primary endpoint (Comparison of the maximum plasma concentration (Cmax)) has not been met as per the results published in the Clinical Therapeutics.
    • 27 Nov 2017 Primary endpoint (Comparison of areas under the curve (AUC) to the last time with a concentration LLOQ [AUC0-t] and to infinity [AUCinf])has been met as per the results published in the Clinical Therapeutics.
    • 27 Nov 2017 Results assessing bioavailability of hydroxyprogesterone caproate administered as a subcutaneous injection published in the Clinical Therapeutics
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