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Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

NCT00667446 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-01-09

Study results available
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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).

Conditions

  • Precocious
  • 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

Interventions

DRUG

Leuprolide Acetate 3 Month Depot

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Peter Bacher, MD · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00667446 on ClinicalTrials.gov