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Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty.
- Source :
-
The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2012 May; Vol. 97 (5), pp. 1572-80. Date of Electronic Publication: 2012 Feb 16. - Publication Year :
- 2012
-
Abstract
- Context: GnRH agonist (GnRHa) monthly injections are frequently used in the treatment of central precocious puberty (CPP). The 3-month leuprolide depot 11.25- and 30-mg formulations are newly approved treatment options.<br />Objective: The aim of the study was to investigate the safety and efficacy of leuprolide acetate 3-month depot formulations for the treatment of CPP in children.<br />Design: This was a phase III, randomized, open-label, dose-ranging 6-month study.<br />Setting: Twenty-two U.S. medical centers (including Puerto Rico) participated.<br />Patients: Children diagnosed with CPP (n = 84), who were either treatment naive or previously treated with GnRHa, were recruited. Chronological age at onset of pubertal signs was less than 8 yr in girls and less than 9 yr in boys, and bone age was advanced over chronological age at least 1 yr.<br />Intervention: Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months.<br />Main Outcome Measures: Biochemical [peak-stimulated LH, estradiol (girls), and testosterone (boys)] and anthropometric (growth rate, bone age acceleration, pubertal progression) parameters and safety were assessed.<br />Results: Peak-stimulated LH was suppressed in the 11.25- and 30-mg dose groups in 78.4 and 95.2%, respectively, of children from months 2 through 6. There were nine treatment failures (peak-stimulated LH >4 IU/liter) in the 11.25-mg group and two in the 30-mg group. Basal sex steroid suppression, growth rates, pubertal progression, bone age advancement, and adverse events were similar with either dose.<br />Conclusions: Treatment with leuprolide acetate 3-month depot formulations (11.25 and 30 mg) effectively suppressed the GnRH axis, was well tolerated, and may positively impact patient convenience and compliance.
- Subjects :
- Child
Child, Preschool
Dose-Response Relationship, Drug
Estradiol blood
Female
Follicle Stimulating Hormone blood
Humans
Infant
Leuprolide administration & dosage
Leuprolide adverse effects
Luteinizing Hormone blood
Male
Puberty, Precocious blood
Testosterone blood
Treatment Outcome
Leuprolide therapeutic use
Puberty, Precocious drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1945-7197
- Volume :
- 97
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- The Journal of clinical endocrinology and metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 22344198
- Full Text :
- https://doi.org/10.1210/jc.2011-2704