A Randomized Trial of 1- and 3-Month Depot Leuprolide Doses in the Treatment of Central Precocious Puberty

• Published in: The Journal of pediatrics Vol. 159; no. 6; pp. 982 - 987.e1
• Main Authors: Fuld, Kimberly, Chi, Carolyn, Neely, E. Kirk
• Format: Journal Article
• Language: English
• Published: Maryland Heights, MO Elsevier Inc 01.12.2011; Mosby, Inc; Elsevier
• Subjects: acetates; administration & dosage; Biological and medical sciences; Child; Delayed-Action Preparations; Drug Administration Schedule; drug therapy; estradiol; Female; follicle-stimulating hormone; General aspects; gonadotropin-releasing hormone; Gynecology. Andrology. Obstetrics; Humans; Leuprolide; Leuprolide - administration & dosage; luteinizing hormone; Male; Medical sciences; Pediatrics; Puberal and climacteric disorders (male and female); puberty; Puberty, Precocious; Puberty, Precocious - drug therapy; therapeutics; Time Factors; LC-MS/MS; CPP; IM; PAH; DL; FSH; GnRH; LH; E2; Intramuscularly; Liquid chromatography/tandem mass spectrometry; Estradiol; Depot preparations of leuprolide acetate; Predicted adult height; Luteinizing hormone; Gonadotropin-releasing hormone; Central precocious puberty; Follicle stimulating hormone; Endocrinopathy; Antineoplastic agent; Pediatrics; Agonist; Leuprorelin; Peptides; Gonadotropin RH; Nonapeptide; Precocious puberty; Hypothalamic hormone; Randomization; Treatment; Analog; Clinical trial; Hormone releasing factor; Dose
• ISSN: 0022-3476; 1097-6833; 1097-6833
• DOI: 10.1016/j.jpeds.2011.05.036

To compare 1-month and 3-month depot formulations of leuprolide acetate (DL), a gonadotropin-releasing hormone analog, in the treatment of central precocious puberty (CPP). Subjects with CPP naïve to therapy were randomized to 7.5 mg of 1-month DL, 11.25 mg of 3-month DL, or 22.5 mg of 3-month DL. Stimulated luteinizing hormone (LH) and follicle-stimulating hormone (FSH) and estradiol levels, growth velocity, and bone age progression were examined in a 2-year period. Forty-nine female and 5 male subjects with CPP were randomized. Mean stimulated LH and FSH levels during treatment were higher in the low-dose 11.25-mg 3-month DL group, and more LH levels >4 IU/L were observed, in comparison with the other two dose groups. Mean LH and FSH levels in the 22.5-mg 3-month group were not different from the monthly DL. No differences in estradiol levels, growth velocity, or bone age progression were observed in dosing groups. All DL doses resulted in prompt and effective suppression of puberty, but higher LH and FSH levels were seen with the 11.25-mg 3-month DL dose. Multi-monthly DL is effective in treating CPP, but higher dosing may be required in some circumstances.