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An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty

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Trial Profile

An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2024

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At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Precocious puberty
  • Focus Therapeutic Use
  • Sponsors Tolmar

Most Recent Events

  • 24 Nov 2020 According to a TOLMAR Pharmaceuticals media release, results from were published in the Journal of Clinical Endocrinology and Metabolism.
  • 04 May 2020 According to a Tolmar Pharmaceuticals media release, based on the data of this study, the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for FENSOLVI (leuprolide acetate) for injectable suspension for the treatment of pediatric patients two years of age and older with central precocious puberty (CPP).
  • 06 Sep 2018 Status changed from active, no longer recruiting to completed.

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