36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty

Peter A. Lee, Karen Klein, Nelly Mauras, Tali Lev-Vaisler, Peter Bacher

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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 showednosigns 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.

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). Copyright

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.

Original languageEnglish (US)
Pages (from-to)3153-3159
Number of pages7
JournalJournal of Clinical Endocrinology and Metabolism
Volume99
Issue number9
DOIs
StatePublished - Sep 1 2014

Fingerprint

Leuprolide
Safety
Maintenance
Pediatrics
Therapeutics
Puberty
Labels
Estradiol
Steroids
Outcome Assessment (Health Care)
Pain
Injections
Central Precocious Puberty
Growth
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

@article{7b2553349274464795da58647a40e9ac,
title = "36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty",
abstract = "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 showednosigns 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.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). CopyrightObjective: 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.",
author = "Lee, {Peter A.} and Karen Klein and Nelly Mauras and Tali Lev-Vaisler and Peter Bacher",
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36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty. / Lee, Peter A.; Klein, Karen; Mauras, Nelly; Lev-Vaisler, Tali; Bacher, Peter.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 99, No. 9, 01.09.2014, p. 3153-3159.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty

AU - Lee, Peter A.

AU - Klein, Karen

AU - Mauras, Nelly

AU - Lev-Vaisler, Tali

AU - Bacher, Peter

PY - 2014/9/1

Y1 - 2014/9/1

N2 - 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 showednosigns 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.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). CopyrightObjective: 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.

AB - 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 showednosigns 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.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). CopyrightObjective: 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.

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