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NCT00667446 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Precocious and Leuprolide Acetate, sponsored by AbbVie (prior sponsor, Abbott).

Completed
Registry status
Phase 3
Development phase
72
Enrollment target
20
Study locations

NCT00667446: Completed Phase 3 study of Precocious and Leuprolide Acetate, sponsored by AbbVie (prior sponsor, Abbott).

NCT00667446 is a Phase 3 study of Precocious and Leuprolide Acetate that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00667446, a Phase 3 study of Precocious and Leuprolide Acetate, has completed, sponsored by AbbVie (prior sponsor, Abbott).

COMPLETED
Registry status
Phase 3
Development phase
72 participants
Enrollment target
20
Study locations

Study 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).

Primary Outcome

Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH \< 4 mIU/mL. Peak-stimulated LH refers to the maximum LH concentration measured 30 and 60 minutes after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test. Participants who failed suppression at previous visit and prematurely discontinued were counted as having failed future visits also. Final visit is the participant's last visit closest to Month 36.

Conditions Studied

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

Interventions

  • DRUG Leuprolide Acetate 3 Month Depot

Study Locations (20)

Other

  • Site Reference ID/Investigator# 23182 - Bayamón
  • Site Reference ID/Investigator# 21721 - Ponce
  • Site Reference ID/Investigator# 25908 - Rio Piedras
  • Site Reference ID/Investigator# 23082 - San Juan

California

  • Site Reference ID/Investigator# 14922 - Long Beach
  • Site Reference ID/Investigator# 26043 - Los Angeles
  • Site Reference ID/Investigator# 20802 - San Diego

Florida

  • Site Reference ID/Investigator# 18181 - Jacksonville
  • Site Reference ID/Investigator# 26364 - Pensacola

Minnesota

  • Site Reference ID/Investigator# 23643 - Minneapolis
  • Site Reference ID/Investigator# 23502 - Saint Paul

Oklahoma

  • Site Reference ID/Investigator# 23802 - Oklahoma City
  • Site Reference ID/Investigator# 13324 - Tulsa

Alabama

  • Site Reference ID/Investigator# 13521 - Birmingham

Colorado

  • Site Reference ID/Investigator# 22425 - Greenwood Village

Indiana

  • Site Reference ID/Investigator# 26983 - Indianapolis

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2008-12
Est. Completion 2013-01
Phase Phase 3
AbbVie (prior sponsor, Abbott)

88 total trials

What the finished NCT00667446 record still lists

NCT00667446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).

The record links to 10 conditions, with Precocious appearing as the primary indexed condition, and to 1 intervention - of which Leuprolide Acetate 3 Month Depot is the first listed.

NCT00667446 names 20 study sites across 12 states, led by Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00667446 about?

NCT00667446 is a clinical study titled "Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty". 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).

What is the current status of trial NCT00667446?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2008-12. Estimated completion is 2013-01.

What conditions does trial NCT00667446 study?

This clinical trial studies the following conditions: Precocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa), Tanner Staging.

What interventions are being tested in trial NCT00667446?

The interventions under investigation include: Leuprolide Acetate 3 Month Depot (DRUG).

Who is sponsoring clinical trial NCT00667446?

This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00667446 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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How this trial's enrollment target compares

Where NCT00667446's enrollment target sits among peer trials

72 1780th of 2000 higher than 217 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00667446, the US trial registry maintained by the National Library of Medicine. NCT00667446 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.