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A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty

NCT00635817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2011-11-02

Study results available
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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).

Conditions

  • Puberty, Precocious

Interventions

DRUG

Leuprolide acetate 11.25 mg

Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.

DRUG

Leuprolide acetate 30 mg

Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.

Sponsors & Collaborators

Principal Investigators

  • Peter Bacher, MD, · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-01-31
Completion
2010-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

Companies

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 NCT00635817 on ClinicalTrials.gov