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A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)

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Trial Profile

A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2024

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At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Precocious puberty
  • Focus Registrational; Therapeutic Use
  • Sponsors AbbVie

Most Recent Events

  • 13 Dec 2023 Status changed from active, no longer recruiting to completed.
  • 09 Sep 2022 Timeframe for primary endpoint reduced from 48 weeks to 24 weeks.
  • 15 Jan 2021 Status changed from recruiting to active, no longer recruiting.

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