title: Treatment of central precocious puberty by subcutaneous injections of leuprorelin 3-month depot (11.25 mg).
abstract: Depot GnRH agonists are widely used for the treatment of precocious puberty. Leuprorelin 3-month depot is currently used in adults but has not been evaluated in children. We evaluated the efficacy of this new formulation (11.25 mg every 3 months), for the suppression of gonadotropic activation and pubertal signs in children with central precocious puberty. We included 44 children (40 girls) with early-onset pubertal development in a 6-month open trial. The inclusion criteria were clinical pubertal development before the age of 8 (girls) or 10 (boys), advanced bone age, enlarged uterus (>36 mm), testosterone more than 1.7 nmol/liter (boys), and pubertal response of LH to GnRH (peak >5 IU/liter). The principal criterion for efficacy assessment, GnRH-stimulated LH peak less than 3 IU/liter, was met in 81 of 85 (95%) of the tests performed at months 3 and 6. The remaining four values were slightly above the threshold. The levels of sex steroids were also significantly reduced and clinical pubertal development was arrested. Plasma leuprorelin levels, measured every 30 d, were essentially stable after d 60. Local intolerance was noted after 10 of 86 injections (12%), and was mild in four cases, moderate in five cases, and severe in one. Among these 10 events, 4 consisted in local pain at injection's site. In conclusion, leuprorelin 3-month depot efficiently inhibits the gonadotropic axis in 95% of children with central precocious puberty studied for a 6-month period. This regimen allows the reduction of the number of yearly injections from 12 to 4.
authors.affiliation: Groupe Hospitalier Cochin-Saint Vincent de Paul, Faculté Cochin-Université Paris V and Institut National de la Santé et de la Recherche Médicale U342, Paris 75014, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Carel
authors.forename: Najiba
authors.initials: N
authors.lastname: Lahlou
authors.forename: Orlando
authors.initials: O
authors.lastname: Jaramillo
authors.forename: Vincent
authors.initials: V
authors.lastname: Montauban
authors.forename: Cécile
authors.initials: C
authors.lastname: Teinturier
authors.forename: Michel
authors.initials: M
authors.lastname: Colle
authors.forename: Christel
authors.initials: C
authors.lastname: Lucas
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Chaussain
mesh_terms: D002648:Child; D003692:Delayed-Action Preparations; D004958:Estradiol / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D007987:Gonadotropin-Releasing Hormone / Q000097:blood; D006801:Humans; D007279:Injections, Subcutaneous; D016729:Leuprolide / Q000008:administration & dosage / Q000627:therapeutic use*; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D011629:Puberty, Precocious / Q000097:blood / Q000188:drug therapy*; D013739:Testosterone / Q000097:blood; D013997:Time Factors
chemical_list: D003692:Delayed-Action Preparations; D007987:Gonadotropin-Releasing Hormone; D013739:Testosterone; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D016729:Leuprolide