At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 64 enrolled
Drug / intervention
Leuprolide Acetate 45 mgdrug
Likely dose
Leuprolide Acetate 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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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
In Brief
A Phase 3 clinical trial evaluating Leuprolide Acetate 45 mg for Precocious Puberty, Central. Completed, enrolled 64 participants across 20 sites in 6 countries.
Detailed Summary
This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrecocious Puberty, Central
CountriesArgentina, Canada, Chile, Mexico, New Zealand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartAug 2015
Primary CompletionSep 2018
TodayJul 2026
First PostedMay 25, 2015
Enrollment StartAug 31, 2015
Primary CompletionSep 5, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.1 years ago
Interventions
Leuprolide Acetate 45 mgdrug
Subcutaneous injection