title: Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty.
abstract: BACKGROUND
  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.
  
  
  METHODS
  This was a phase III, randomized, open-label, dose-ranging 6-month study.
  
  
  METHODS
  Twenty-two U.S. medical centers (including Puerto Rico) participated.
  
  
  METHODS
  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.
  
  
  METHODS
  Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months.
  
  
  METHODS
  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.
authors.affiliation: Penn State College of Medicine, The Milton S. Hershey Medical Center, P.O. Box 850, Hershey, Pennsylvania 17033-0850, USA. plee@psu.edu
authors.forename: Peter A
authors.initials: PA
authors.lastname: Lee
authors.forename: Karen
authors.initials: K
authors.lastname: Klein
authors.forename: Nelly
authors.initials: N
authors.lastname: Mauras
authors.forename: E Kirk
authors.initials: EK
authors.lastname: Neely
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Bloch
authors.forename: Lois
authors.initials: L
authors.lastname: Larsen
authors.forename: Cynthia
authors.initials: C
authors.lastname: Mattia-Goldberg
authors.forename: Kristof
authors.initials: K
authors.lastname: Chwalisz
mesh_terms: D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007223:Infant; D016729:Leuprolide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D011629:Puberty, Precocious / Q000097:blood / Q000188:drug therapy*; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome
chemical_list: D013739:Testosterone; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D016729:Leuprolide