Multicenter clinical trial of leuprolide acetate depot (Luphere depot 3.75 mg) for efficacy and safety in girls with central precocious puberty.

Abstract

PurposeWe 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.MethodsA 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.ConclusionThe leuprolide 3.75 mg (Luphere depot) is useful and safety for treating children with central precocious puberty.