Efficacy and safety of leuprolide acetate 3-month depot 11.25 milligrams or 30 milligrams for the treatment of central precocious puberty.

Lee PA, Klein K, Mauras N, Neely EK, Bloch CA, Larsen L, Mattia-Goldberg C, Chwalisz K

The Journal of clinical endocrinology and metabolism16 Feb 2012Cited by 52 (Europe PMC)

PMID22344198DOI10.1210/jc.2011-2704PepBankPUB-22344198

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialOther
In children with central precocious puberty, sex steroid suppression, growth, pubertal progression, bone age advancement and adverse events were similar between leuprolide doses.
In plain wordsIn children with early puberty, hormone suppression, growth, puberty progression, bone age and adverse events were similar with both leuprolide doses.
Peptide
Leuprolide
Outcome
Direction not reportedSex steroid suppression, growth, pubertal progression, bone age and adverse events
Study
n = 84
Comparator
Leuprolide 30 mg every 3 months
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · intramuscular · 6 monthsAs given in this study (human).
Source sentences
Summary
Basal sex steroid suppression, growth rates, pubertal progression, bone age advancement, and adverse events were similar with either dose.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, randomized, open-label, dose-ranging 6-month study.
Summary · context
Children diagnosed with CPP (n = 84), who were either treatment naive or previously treated with GnRHa, were recruited.
Summary · context
Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months.
Report a problemFND-2234419805
02HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, leuprolide 11.25 mg suppressed peak-stimulated LH in 78.4% from months 2 through 6.
In plain wordsIn children with early puberty, leuprolide 11.25 mg suppressed stimulated LH in 78.4% from months 2 through 6.
Peptide
Leuprolide
Outcome
DecreasePeak-stimulated LH suppression at 11.25 mg
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · intramuscular · 6 monthsAs given in this study (human).
Measurements
Children with suppressed peak-stimulated LH, months 2 through 6
78.4%
leuprolide 11.25-mg group
Source sentences
Summary
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.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, randomized, open-label, dose-ranging 6-month study.
Summary · context
Children diagnosed with CPP (n = 84), who were either treatment naive or previously treated with GnRHa, were recruited.
Summary · context
Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months.
Report a problemFND-2234419801
03HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, leuprolide 30 mg suppressed peak-stimulated LH in 95.2% from months 2 through 6.
In plain wordsIn children with early puberty, leuprolide 30 mg suppressed stimulated LH in 95.2% from months 2 through 6.
Peptide
Leuprolide
Outcome
DecreasePeak-stimulated LH suppression at 30 mg
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
30 mg every 3 months · intramuscular · 6 monthsAs given in this study (human).
Measurements
Children with suppressed peak-stimulated LH, months 2 through 6
95.2%
leuprolide 30-mg group
Source sentences
Summary
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.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, randomized, open-label, dose-ranging 6-month study.
Summary · context
Children diagnosed with CPP (n = 84), who were either treatment naive or previously treated with GnRHa, were recruited.
Summary · context
Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months.
Report a problemFND-2234419802
04HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, nine leuprolide 11.25-mg recipients had treatment failure with peak-stimulated LH >4 IU/liter.
In plain wordsIn children with early puberty, nine leuprolide 11.25-mg recipients had treatment failure with stimulated LH >4 IU/liter.
Peptide
Leuprolide
Outcome
Not applicableTreatment failures at 11.25 mg
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · intramuscular · 6 monthsAs given in this study (human).
Measurements
Treatment failures (peak-stimulated LH > 4 IU/liter)
9 children
leuprolide 11.25-mg group
Source sentences
Summary
There were nine treatment failures (peak-stimulated LH >4 IU/liter) in the 11.25-mg group and two in the 30-mg group.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, randomized, open-label, dose-ranging 6-month study.
Summary · context
Children diagnosed with CPP (n = 84), who were either treatment naive or previously treated with GnRHa, were recruited.
Summary · context
Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months.
Report a problemFND-2234419803
05HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, two leuprolide 30-mg recipients had treatment failure with peak-stimulated LH >4 IU/liter.
In plain wordsIn children with early puberty, two leuprolide 30-mg recipients had treatment failure with stimulated LH >4 IU/liter.
Peptide
Leuprolide
Outcome
Not applicableTreatment failures at 30 mg
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
30 mg every 3 months · intramuscular · 6 monthsAs given in this study (human).
Measurements
Treatment failures (peak-stimulated LH > 4 IU/liter)
2 children
leuprolide 30-mg group
Source sentences
Summary
There were nine treatment failures (peak-stimulated LH >4 IU/liter) in the 11.25-mg group and two in the 30-mg group.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, randomized, open-label, dose-ranging 6-month study.
Summary · context
Children diagnosed with CPP (n = 84), who were either treatment naive or previously treated with GnRHa, were recruited.
Summary · context
Leuprolide acetate depot (11.25 or 30 mg) was administered im every 3 months.
Report a problemFND-2234419804

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00635817

A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty

Abbottn = 84Jun 2008 to Jun 2010

Puberty, Precocious

Trial page ClinicalTrials.govUpdated 2 Nov 2011

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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