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document
36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty . CONTEXT We have recently demonstrated short-term ( 6-month ) efficacy and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with central precocious puberty ( CPP ) . OBJECTIVE To assess long-term ( 36-month ) hypothalamic-pituitary-gonadal axis suppression and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with CPP . DESIGN Open-label , 36-month extension . SETTING Twenty pediatric endocrine centers . PATIENTS Seventy-two children ( mean age , 8.5 ± 1.6 y ; 65 females ) with CPP completed and showed maintenance of LH suppression after a 6-month lead-in study . INTERVENTION Leuprolide acetate depot ( 11.25 or 30 mg ) administered im every 3 months . MAIN OUTCOME MEASURES Peak-stimulated LH , estradiol , T , growth rate , pubertal progression , and adverse events ( AEs ) . RESULTS Twenty-nine of 34 subjects in the 11.25-mg group and 36 of 38 subjects in the 30-mg group had LH values < 4 mIU/mL after day 1 at all time points . All seven subjects who escaped LH suppression at any time still maintained sex steroid concentrations at prepubertal levels and showed no signs of pubertal progression . AEs were comparable between groups , with injection site pain being the most common ( 26.4 % overall ) . No AE led to discontinuation of study drug . The safety profile over 36 months was comparable to that observed during the 6-month pivotal study . CONCLUSIONS The two doses of leuprolide acetate 3-month depot were associated with an acceptable safety profile and provided maintenance of LH suppression in the majority of children with CPP during the 36 months of the study or until readiness for puberty .
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Intervention_Pharmacological
leuprolide acetate 3-month depot
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Intervention_Pharmacological
leuprolide acetate 3-month depot
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Intervention_Pharmacological
leuprolide acetate 3-month depot
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Outcome_Physical
hypothalamic-pituitary-gonadal axis suppression
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Outcome_Other
safety
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Outcome_Physical
showed maintenance of LH suppression
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Outcome_Physical
Peak-stimulated LH
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Outcome_Physical
estradiol
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Outcome_Physical
T
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Outcome_Physical
growth rate
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Outcome_Physical
pubertal progression
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Outcome_Adverse-effects
adverse events ( AEs )
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Outcome_Other
had
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Outcome_Physical
LH values
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Outcome_Physical
LH suppression
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Outcome_Physical
maintained sex steroid concentrations
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Outcome_Physical
of pubertal progression
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Outcome_Adverse-effects
AEs
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Outcome_Pain
with injection site pain
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Outcome_Adverse-effects
No AE
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Outcome_Other
The safety profile
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Outcome_Other
an acceptable safety profile
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Outcome_Physical
provided maintenance of LH suppression