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document
Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty . CONTEXT GnRH agonist ( GnRHa ) monthly injections are frequently used in the treatment of central precocious puberty ( CPP ) . The 3-month leuprolide depot 11.25- and 30-mg formulations are newly approved treatment options . OBJECTIVE The aim of the study was to investigate the safety and efficacy of leuprolide acetate 3-month depot formulations for the treatment of CPP in children . DESIGN This was a phase III , randomized , open-label , dose-ranging 6-month study . SETTING Twenty-two U.S. medical centers ( including Puerto Rico ) participated . PATIENTS Children diagnosed with CPP ( n = 84 ) , who were either treatment naive or previously treated with GnRHa , were recruited . Chronological age at onset of pubertal signs was less than 8 yr in girls and less than 9 yr in boys , and bone age was advanced over chronological age at least 1 yr . INTERVENTION Leuprolide acetate depot ( 11.25 or 30 mg ) was administered im every 3 months . MAIN OUTCOME MEASURES Biochemical [ peak-stimulated LH , estradiol ( girls ) , and testosterone ( boys ) ] and anthropometric ( growth rate , bone age acceleration , pubertal progression ) parameters and safety were assessed . RESULTS Peak-stimulated LH was suppressed in the 11.25- and 30-mg dose groups in 78.4 and 95.2 % , respectively , of children from months 2 through 6 . There were nine treatment failures ( peak-stimulated LH > 4 IU/liter ) in the 11.25-mg group and two in the 30-mg group . Basal sex steroid suppression , growth rates , pubertal progression , bone age advancement , and adverse events were similar with either dose . CONCLUSIONS Treatment with leuprolide acetate 3-month depot formulations ( 11.25 and 30 mg ) effectively suppressed the GnRH axis , was well tolerated , and may positively impact patient convenience and compliance .
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Intervention_Pharmacological
leuprolide acetate 3-month
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Intervention_Pharmacological
3-month leuprolide depot 11.25-
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Intervention_Pharmacological
leuprolide acetate 3-month
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Intervention_Pharmacological
Leuprolide acetate depot
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Intervention_Pharmacological
leuprolide acetate
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Outcome_Other
Efficacy and safety
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Outcome_Physical
Biochemical [ peak-stimulated LH , estradiol ( girls ) , and testosterone ( boys ) ] and anthropometric ( growth rate , bone age acceleration , pubertal progression ) parameters
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Outcome_Physical
Basal sex steroid suppression
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Outcome_Physical
growth rates
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Outcome_Physical
pubertal progression
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Outcome_Physical
bone age advancement
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Outcome_Adverse-effects
adverse events