CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 55 enrolled
Drug / intervention
Lupron (leuprolide acetate)drug
Likely dose
Lupron (leuprolide acetate) 300 mcg/kgfrom 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.

Search/NCT00660010
NCT00660010Phase 3Completed
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Study of Lupron Depot In The Treatment of Central Precocious Puberty

Abbott·interventional·Posted Apr 17, 2008·Updated Apr 12, 2011

In Brief

A Phase 3 clinical trial evaluating Lupron (leuprolide acetate) for Puberty, Precocious. Completed, enrolled 55 participants across 9 sites.

Detailed Summary

The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and effective in treating children with Central Precocious Puberty (CPP), and to assess long term effects of leuprolide acetate treatment after therapy is discontinued.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPuberty, Precocious
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartJan 1, 1991
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 18.3 yearsPosted 18.2 years ago

Interventions

Lupron (leuprolide acetate)drug

Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.