At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 84 enrolled
Drug / intervention
Leuprolide acetate 11.25 mg +1 moredrug
Likely dose
Leuprolide acetate 11.25 mgfrom 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, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulations in Children With Central Precocious Puberty
In Brief
A Phase 3 clinical trial evaluating Leuprolide acetate 11.25 mg and Leuprolide acetate 30 mg for Puberty, Precocious. Completed, enrolled 84 participants across 25 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPuberty, Precocious
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartJun 2008
Primary CompletionJan 2010
Study CompletionJun 2010
TodayJul 2026
First PostedMar 14, 2008
Enrollment StartJun 1, 2008
Primary CompletionJan 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.3 years ago
Interventions
Leuprolide acetate 11.25 mgdrug
Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.
Leuprolide acetate 30 mgdrug
Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.