Multicenter clinical trial of leuprolide acetate depot (Luphere depot 3.75 mg) for efficacy and safety in girls with central precocious puberty.
10.6065/apem.2013.18.4.173
- Author:
You Jin KIM
1
;
Hae Sang LEE
;
Young Jun LEE
;
Jung Sub LIM
;
Se Young KIM
;
Eun Young KIM
;
Dong Kyu JIN
;
Il Tae HWANG
;
Jin Soon HWANG
Author Information
1. Department of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea. pedhwang@ajou.ac.kr
- Publication Type:Clinical Trial ; Multicenter Study ; Original Article
- Keywords:
Leuprolide acetate;
Central precocious puberty;
Treatment outcome
- MeSH:
Child;
Eating;
Female*;
Gonadotropin-Releasing Hormone;
Humans;
Leuprolide*;
Luteinizing Hormone;
Puberty, Precocious*;
Treatment Outcome;
Surveys and Questionnaires
- From:Annals of Pediatric Endocrinology & Metabolism
2013;18(4):173-178
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: 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< or =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< or =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. CONCLUSION: The leuprolide 3.75 mg (Luphere depot) is useful and safety for treating children with central precocious puberty.
