At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 45 enrolled
Drug / intervention
Leuprolide Acetate (LA)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Leuprolide Acetate (LA) for Central Precocious Puberty (CPP). Completed, enrolled 45 participants across 18 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Precocious Puberty (CPP)
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartOct 2018
Primary CompletionMay 2021
Study CompletionNov 2023
TodayJul 2026
First PostedOct 4, 2018
Enrollment StartOct 24, 2018
Primary CompletionMay 6, 2021
Study CompletionNov 29, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.7 years ago
Interventions
Leuprolide Acetate (LA)drug
Administered intramuscularly as an injection