title: Multicenter clinical trial of leuprolide acetate depot (Luphere depot 3.75 mg) for efficacy and safety in girls with central precocious puberty.
abstract: OBJECTIVE
  We evaluated the efficacy, safety and psychological aspect of monthly administrations of the gonadotropin-releasing hormone agonists (GnRHa), leuprolide acetate depot (Luphere depot 3.75 mg), in patients with precocious puberty.
  
  
  METHODS
  A total of 54 girls with central precocious puberty were administered with leuprolide acetate (Luphere depot 3.75 mg) every four weeks over 24 weeks. We evaluated the percentage of children exhibiting a suppressed luteinizing hormone (LH) response to GnRH (LH peak≤3 IU/L), peak LH/follicle stimulating hormone (FSH) ratio of GnRH stimulation test less than 1, change in bone age/chronologic age ratio, change in the Tanner stage and change in eating habit and psychological aspect.
  
  
  RESULTS
  (1) The percentage of children exhibiting a suppressed LH response to GnRH, defined as an LH peak≤3 IU/L at 24 weeks was 96.3 % (52/54). (2) The percentage of children exhibiting peak LH/FSH ratio<1 at 24 weeks of the study was 94.4 % (51/54). (3) The ratio of bone age and chronological age significantly declined from 1.27±0.07 to 1.24±0.01 after the 6 months of the study. (4) The mean Tanner stage manifested a significant change 2.3±0.48 at baseline, down to 1.70±0.61 at 24 weeks. (5) Based on the questionnaires, the score for eating habits showed a significant change from the baseline 34.0±6.8 to 31.3±6.8. (6) The psychological assessment did not exhibit a significant difference except with scores for sociability, problem behavior total score and other problems.
  
  
  CONCLUSIONS
  The leuprolide 3.75 mg (Luphere depot) is useful and safety for treating children with central precocious puberty.
authors.affiliation: Department of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.
authors.forename: You Jin
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Hae Sang
authors.initials: HS
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Korea University Ansan Hospital, Ansan, Korea.
authors.forename: Young Jun
authors.initials: YJ
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Korea.
authors.forename: Jung Sub
authors.initials: JS
authors.lastname: Lim
authors.affiliation: Department of Pediatrics, Bundang Jesang Hospital, Seongnam, Korea.
authors.forename: Se Young
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Chosun University School of Medicine, Gwangju, Korea.
authors.forename: Eun Young
authors.initials: EY
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Samsung Medical Center, Seoul, Korea.
authors.forename: Dong Kyu
authors.initials: DK
authors.lastname: Jin
authors.affiliation: Department of Pediatrics, Hallym University Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
authors.forename: Il Tae
authors.initials: IT
authors.lastname: Hwang
authors.affiliation: Department of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Jin Soon
authors.initials: JS
authors.lastname: Hwang
keywords: Central precocious puberty; Leuprolide acetate; Treatment outcome