drugset / Trial / NCT03695237

A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

NCT03695237

Phase 3 Completed 45 enrolled AbbVie
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.

Timeline

Start
2018-10-24
Primary completion
2021-05-06
Completion
2023-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Leuprolide Other / unclassified 45 mg Intramuscular