Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty

TitleEfficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty
Publication TypeJournal Article
Year of Publication2012
AuthorsLee, P. A., Klein K., Mauras N., Neely E. K., Bloch C. A., Larsen L., Mattia-Goldberg C., & Chwalisz K.
JournalThe Journal of clinical endocrinology and metabolism
Volume97
Issue5
Pagination1572-80
Date Published2012 May
ISSN1945-7197
KeywordsChild; Child, Preschool; Dose-Response Relationship, Drug; Estradiol; Female; Follicle Stimulating Hormone; Humans; Infant; Leuprolide; Luteinizing Hormone; Male; Puberty, Precocious; Testosterone; Treatment Outcome
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.
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.
DESIGN: This was a phase III, randomized, open-label, dose-ranging 6-month study.
SETTING: Twenty-two U.S. medical centers (including Puerto Rico) participated.
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.
INTERVENTION: Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months.
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.
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.
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.









DOI10.1210/jc.2011-2704
Alternate JournalJ. Clin. Endocrinol. Metab
Refereed DesignationRefereed