title: 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty.
abstract: BACKGROUND
  We have recently demonstrated short-term (6-month) efficacy and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with central precocious puberty (CPP).
  
  
  OBJECTIVE
  To assess long-term (36-month) hypothalamic-pituitary-gonadal axis suppression and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with CPP.
  
  
  METHODS
  Open-label, 36-month extension.
  
  
  METHODS
  Twenty pediatric endocrine centers.
  
  
  METHODS
  Seventy-two children (mean age, 8.5 ± 1.6 y; 65 females) with CPP completed and showed maintenance of LH suppression after a 6-month lead-in study.
  
  
  METHODS
  Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.
  
  
  METHODS
  Peak-stimulated LH, estradiol, T, growth rate, pubertal progression, and adverse events (AEs).
  
  
  RESULTS
  Twenty-nine of 34 subjects in the 11.25-mg group and 36 of 38 subjects in the 30-mg group had LH values < 4 mIU/mL after day 1 at all time points. All seven subjects who escaped LH suppression at any time still maintained sex steroid concentrations at prepubertal levels and showed no signs of pubertal progression. AEs were comparable between groups, with injection site pain being the most common (26.4% overall). No AE led to discontinuation of study drug. The safety profile over 36 months was comparable to that observed during the 6-month pivotal study.
  
  
  CONCLUSIONS
  The two doses of leuprolide acetate 3-month depot were associated with an acceptable safety profile and provided maintenance of LH suppression in the majority of children with CPP during the 36 months of the study or until readiness for puberty.
authors.affiliation: Penn State School of Medicine (P.A.L.), Hershey, Pennsylvania 17033; Indiana University School of Medicine (P.A.L.), Indianapolis, Indiana 46202; University of California San Diego (K.K.), San Diego, California 92093; Nemours Children's Clinic (N.M.), Jacksonville, Florida 32207; and AbbVie (T.L.-V., P.B.), North Chicago, Illinois 60064.
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: Tali
authors.initials: T
authors.lastname: Lev-Vaisler
authors.forename: Peter
authors.initials: P
authors.lastname: Bacher
mesh_terms: D000728:Androgens / Q000097:blood; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects; D016729:Leuprolide / Q000008:administration & dosage* / Q000009:adverse effects*; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D011629:Puberty, Precocious / Q000188:drug therapy*; D012741:Sexual Maturation / Q000187:drug effects
chemical_list: D000728:Androgens; D018931:Antineoplastic Agents, Hormonal; D007987:Gonadotropin-Releasing Hormone; D004958:Estradiol; D007986:Luteinizing Hormone; D016729:Leuprolide