Original ArticleA Randomized Trial of 1- and 3-Month Depot Leuprolide Doses in the Treatment of Central Precocious Puberty
Section snippets
Methods
Beginning in 2005, all patients in the Pediatric Endocrine Clinic at Lucile Packard Children’s Hospital at Stanford who were commencing GnRH analog therapy for CPP were invited to participate in the study. CPP in girls was defined clinically as onset of breast development before 8.0 years of age. CPP in boys was defined as Tanner 2 genital stage and testicular volume >4 cc before 9.0 years of age. Minimal laboratory inclusion criterion was a random LH level >0.3 IU/L12, 13 or aqueous
Results
Characteristics of the 54 enrolled subjects are shown in Table I. Mean age at the start of DL therapy for all subjects was 8.1 ± 1.9 years, including 4 patients with diagnoses other than precocious puberty, who were older on average. Most subjects in all groups had a diagnosis of idiopathic CPP. There were no significant differences in starting age, height, weight, and bone age when comparing the 3 dose groups. The initial mean stimulated LH and E2 levels also did not differ in dose groups.
Discussion
GnRH analogs are standard for treatment of CPP, and their efficacy and safety are well established.1, 2, 3, 4 We demonstrate in a direct randomized trial that 3-month DL has similar efficacy and safety compared with the monthly form. With either of the 3-month DL preparations, stimulated LH and serum E2 concentrations declined approximately 10-fold from baseline to the first follow-up visit and were sustained in that range for 2 years. Bone age advancement and growth velocity were comparably
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E.N. has received research support from and has been a consultant, advisory board member, or both for Abbott and Endo Pharmaceuticals. The other authors declare no conflicts of interest.