drugset / Trial / NCT00635817
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2008-06
- Primary completion
- 2010-01
- Completion
- 2010-06
Publications
- Lim CN, Al Yacoub ON, Mostafa NM, Salem AH. Fixed Dosing of Leuprolide Acetate, a GnRH Agonist, in Children with Central Precocious Puberty: A Population Pharmacokinetic Justification. Paediatr Drugs. 2026 May;28(3):295-305. doi: 10.1007/s40272-025-00733-2. Epub 2026 Mar 13.
- Lee PA, Klein K, Mauras N, Neely EK, Bloch CA, Larsen L, Mattia-Goldberg C, Chwalisz K. Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty. J Clin Endocrinol Metab. 2012 May;97(5):1572-80. doi: 10.1210/jc.2011-2704. Epub 2012 Feb 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leuprolide | Other / unclassified | 11.25 mg | Intramuscular |
| Subject | Leuprolide | Other / unclassified | 30 mg | Intramuscular |