At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 72 enrolled
Drug / intervention
Leuprolide Acetate 3 Month Depotdrug
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 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty
In Brief
A Phase 3 clinical trial evaluating Leuprolide Acetate 3 Month Depot for Precocious and 11 related conditions. Completed, enrolled 72 participants across 20 sites in 2 countries.
Detailed Summary
The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrecocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa), Tanner Staging, Depot Formulation, Suppression of LH, Central Precocious Puberty (CPP), Gonadotrophin-releasing Hormone (GnRH), Lupron, GnRH Analog, Pediatrics Central Precocious Puberty
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartDec 2008
Primary CompletionOct 2012
Study CompletionJan 2013
TodayJul 2026
First PostedApr 28, 2008
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.2 years ago
Interventions
Leuprolide Acetate 3 Month Depotdrug