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

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

Completed
Phase of Trial: Phase I

Latest Information Update: 29 Jun 2017

At a glance

  • Drugs Hydroxyprogesterone (Primary) ; Hydroxyprogesterone (Primary)
  • Indications Preterm labour
  • Focus Pharmacokinetics
  • Sponsors AMAG Pharmaceuticals
  • Most Recent Events

    • 26 Jun 2017 According to an AMAG Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) has accepted the supplemental new drug application (sNDA) for Makena (hydroxyprogesterone caproate injection) subcutaneous auto-injector to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.
    • 26 Jun 2017 Status changed from active, no longer recruiting to completed.
    • 17 Apr 2017 According to an AMAG Pharmaceuticals media release, the company has submitted a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) for Makena (hydroxyprogesterone caproate injection) subcutaneous auto-injector to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past. The application is based on results from this trial.
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