NCT00635817 is a Phase 3 clinical trial of Leuprolide acetate 11.25 mg in Puberty, Precocious, sponsored by Abbott.

Who is sponsoring NCT00635817?

NCT00635817 is sponsored by Abbott.

What drugs are being tested in NCT00635817?

Interventions in NCT00635817: Leuprolide acetate 11.25 mg, Leuprolide acetate 30 mg.

What condition does NCT00635817 study?

NCT00635817 studies Puberty, Precocious.

Is NCT00635817 still recruiting?

NCT00635817 is currently completed. Last updated 25 October 2011.

Are results published for NCT00635817?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2011-10-25 · How we verify

NCT00635817

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 25 October 2011

What this trial tests

Phase 3 trial testing Leuprolide acetate 11.25 mg in Puberty, Precocious in 84 participants. Completed in 1 June 2010.

Timeline

1 June 2008

Primary endpoint
1 January 2010

1 June 2010

Quick facts

Lead sponsor	Abbott
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	1 June 2008
Primary completion	1 January 2010
Estimated completion	1 June 2010
Sites	25 locations across United States, Puerto Rico

Drugs / interventions tested

Leuprolide acetate 11.25 mg — full drug profile →
Leuprolide acetate 30 mg — full drug profile →

Conditions studied

Puberty, Precocious — all drugs for Puberty, Precocious →

Sponsor

Abbott — full company profile →

Who can join

Adults 2 to 11, any sex, with Puberty, Precocious. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6
Time frame: Month 2 through 6
Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone \>= 4 mIU/mL were censored at their last measurement of peak-stimulated l

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Fixed Dosing of Leuprolide Acetate, a GnRH Agonist, in Children with Central Precocious Puberty: A Population Pharmacokinetic Justification.
Lim CN, Al Yacoub ON, Mostafa NM, Salem AH. · · 2026 · PMID 41824265 · DOI 10.1007/s40272-025-00733-2

Verify or expand the search:

Other recruiting trials for Puberty, Precocious

Currently open trials in the same condition.

NCT06263868 — First Observatory of Precocious Puberty. · recruiting
NCT06083415 — Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context · NA · recruiting
NCT04884620 — The 3rd COPENHAGEN Puberty Study · recruiting

Other Abbott trials

Trials by the same sponsor.

NCT06217393 — Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia · Phase 3 · completed
NCT05370703 — A Clinical Study to Evaluate the Effect of Mobile Applications "My A:Care" and "Smart Coach" on the Lipid-lowering Treat · completed
NCT05519514 — Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects · Phase 1 · completed
NCT04784208 — A Study to Determine the Validity and Sensitivity of 'Questionnaire to Screen for HYpothyroidism' (Q'SHY) · unknown
NCT05175131 — Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00635817 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott
Last refreshed: 25 October 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00635817.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing