Document Detail


Three-month sustained-release triptorelin (11.25 mg) in the treatment of central precocious puberty.
MedLine Citation:
PMID:  16382000     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Depot GnRH agonists are commonly used in the treatment of central precocious puberty (CPP). The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP. DESIGN: This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly. METHODS: Children with a clinical onset of pubertal development before the age of 8 years (girls) or 9 years (boys), pubertal response of LH to GnRH > or = 7 IU/l, advanced bone age > 1 year, enlarged uterus (> or = 36 mm) and testosterone level > or = 0.5 ng/ml (boys), were included. Suppression of gonadotropic activation, as determined from serum LH, FSH, estradiol or testosterone, and pubertal signs were assessed at Months 3, 6 and 12. RESULTS: GnRH-stimulated peak LH < or = 3 IU/l, the main efficacy criterion, was met in 53 out of 62 (85%), 60 out of 62 (97%) and 56 out of 59 (95%) of the children at Months 3, 6 and 12 respectively. Serum FSH and sex steroids were also significantly reduced, while pubertal development regressed in most patients. Mean residual triptorelin levels were stable from Month 3 through to Month 12. The triptorelin 3-month depot was well tolerated. Severe injection pain was experienced in only one instance. Five girls experienced mild-to-moderate or severe (one girl) withdrawal bleeding. CONCLUSIONS: The triptorelin 3-month depot efficiently suppresses the pituitary-gonadal axis and pubertal development in children with CPP. This formulation allows a 3-fold reduction, over the once-a-month depot, in the number of i.m. injections required each year.
Authors:
Jean-Claude Carel; Joëlle Blumberg; Christine Seymour; Catherine Adamsbaum; Najiba Lahlou;
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  European journal of endocrinology / European Federation of Endocrine Societies     Volume:  154     ISSN:  0804-4643     ISO Abbreviation:  Eur. J. Endocrinol.     Publication Date:  2006 Jan 
Date Detail:
Created Date:  2005-12-29     Completed Date:  2006-03-10     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9423848     Medline TA:  Eur J Endocrinol     Country:  England    
Other Details:
Languages:  eng     Pagination:  119-24     Citation Subset:  IM    
Affiliation:
Department of Pediatric Endocrinology and INSERM U561, Groupe Hospitalier Cochin-Saint Vincent de Paul and Faculté Cochin-Université Paris V, 75014 Paris, France. carel@paris5.inserm.fr
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MeSH Terms
Descriptor/Qualifier:
Child
Delayed-Action Preparations / administration & dosage
Estradiol / blood
Female
Follicle Stimulating Hormone / blood
Gonadotropin-Releasing Hormone / diagnostic use
Humans
Luteinizing Hormone / blood
Male
Puberty, Precocious / drug therapy*
Testosterone / blood
Triptorelin / administration & dosage,  adverse effects,  therapeutic use*
Chemical
Reg. No./Substance:
0/Delayed-Action Preparations; 33515-09-2/Gonadotropin-Releasing Hormone; 50-28-2/Estradiol; 57773-63-4/Triptorelin; 58-22-0/Testosterone; 9002-67-9/Luteinizing Hormone; 9002-68-0/Follicle Stimulating Hormone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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