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Study · Non-randomized trial · n = 72 · 2014

8 results

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

Lee PA, Klein K, Mauras N, Lev-Vaisler T, Bacher P

The Journal of clinical endocrinology and metabolism13 Jun 2014Cited by 34 (Europe PMC)

PMID24926950 (opens in a new tab)DOI10.1210/jc.2013-4471 (opens in a new tab)PepBankPUB-24926950
Publisher pagePubMedAsk about this study
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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 study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In children with central precocious puberty, adverse events were comparable between leuprolide 11.25 mg and 30 mg groups.

    In plain wordsIn children with early puberty, adverse events were similar with the two leuprolide doses.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedAdverse events between doses
    Study

    n = 72

    Comparator
    Leuprolide 30 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    11.25 mg · intramuscular every 3 months · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    AEs were comparable between groups, with injection site pain being the most common (26.4% overall).
    3 context sentences
    Summary · context
    Open-label, 36-month extension.
    Summary · context
    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.
    Summary · context
    Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.
  2. 02HumanNon-randomized trialSafety outcome

    In children with central precocious puberty, injection site pain was the most common adverse event with leuprolide, affecting 26.4% overall.

    In plain wordsIn children with early puberty, 26.4% reported injection site pain during leuprolide treatment.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedInjection site pain
    Study

    n = 72

    Outcome group
    Pain · Skin and wound
    Studied dose
    11.25 or 30 mg · intramuscular every 3 months · 36 monthsAs given in this study (human).

    Measurements

    Injection site pain incidence
    26.4%
    overall, most common adverse event

    Source sentences

    Summary
    AEs were comparable between groups, with injection site pain being the most common (26.4% overall).
    3 context sentences
    Summary · context
    Open-label, 36-month extension.
    Summary · context
    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.
    Summary · context
    Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.
  3. 03HumanNon-randomized trialSafety outcome

    In children with central precocious puberty, no adverse event caused leuprolide discontinuation.

    In plain wordsIn children with early puberty, no adverse event caused treatment discontinuation with leuprolide.

    Peptide
    Leuprolide
    Outcome
    Not applicableAdverse event discontinuations
    Study

    n = 72

    Outcome group
    Adverse events · Whole body
    Studied dose
    11.25 or 30 mg · intramuscular every 3 months · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    No AE led to discontinuation of study drug.
    3 context sentences
    Summary · context
    Open-label, 36-month extension.
    Summary · context
    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.
    Summary · context
    Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.
  4. 04HumanNon-randomized trialSafety outcome

    In children with central precocious puberty, leuprolide safety over 36 months was comparable to the 6-month pivotal study.

    In plain wordsIn children with early puberty, leuprolide safety over 36 months was similar to the earlier study.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedLong-term safety profile
    Study

    n = 72

    Comparator
    6-month pivotal study
    Outcome group
    Adverse events · Whole body
    Studied dose
    11.25 or 30 mg · intramuscular every 3 months · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    The safety profile over 36 months was comparable to that observed during the 6-month pivotal study.
    3 context sentences
    Summary · context
    Open-label, 36-month extension.
    Summary · context
    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.
    Summary · context
    Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.
  5. 05HumanNon-randomized trialEfficacy outcome

    In children with central precocious puberty, 36 of 38 receiving leuprolide 30 mg maintained LH below 4 mIU/mL after day 1.

    In plain wordsIn children with early puberty, 36 of 38 receiving leuprolide 30 mg maintained low LH levels.

    Peptide
    Leuprolide
    Outcome
    Not applicableMaintained LH suppression
    Study

    n = 38

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    30 mg · intramuscular every 3 months · 36 monthsAs given in this study (human).

    Measurements

    Subjects with LH < 4 mIU/mL after day 1 at all time points
    36 subjects
    leuprolide 30-mg group, n = 38

    Source sentences

    Summary
    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.
    3 context sentences
    Summary · context
    Open-label, 36-month extension.
    Summary · context
    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.
    Summary · context
    Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.
  6. 06HumanNon-randomized trialEfficacy outcome

    In children with central precocious puberty, 29 of 34 receiving leuprolide 11.25 mg maintained LH below 4 mIU/mL after day 1.

    In plain wordsIn children with early puberty, 29 of 34 receiving leuprolide 11.25 mg maintained low LH levels.

    Peptide
    Leuprolide
    Outcome
    Not applicableMaintained LH suppression
    Study

    n = 34

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    11.25 mg · intramuscular every 3 months · 36 monthsAs given in this study (human).

    Measurements

    Subjects with LH < 4 mIU/mL after day 1 at all time points
    29 subjects
    leuprolide 11.25-mg group, n = 34

    Source sentences

    Summary
    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.
    3 context sentences
    Summary · context
    Open-label, 36-month extension.
    Summary · context
    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.
    Summary · context
    Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.
  7. 07HumanNon-randomized trialEfficacy outcome

    In children with central precocious puberty, all seven with LH suppression escape maintained prepubertal sex steroid concentrations during leuprolide therapy.

    In plain wordsIn seven children with early puberty and LH escape, sex steroid levels remained prepubertal during leuprolide therapy.

    Peptide
    Leuprolide
    Outcome
    Not applicableSex steroid suppression despite LH escape
    Study

    n = 7

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    11.25 or 30 mg · intramuscular every 3 months · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    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.
    3 context sentences
    Summary · context
    Open-label, 36-month extension.
    Summary · context
    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.
    Summary · context
    Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.
  8. 08HumanNon-randomized trialEfficacy outcome

    In children with central precocious puberty, all seven with LH suppression escape showed no pubertal progression during leuprolide therapy.

    In plain wordsIn seven children with early puberty and LH escape, puberty did not progress during leuprolide therapy.

    Peptide
    Leuprolide
    Outcome
    No significant changePubertal progression despite LH escape
    Study

    n = 7

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    11.25 or 30 mg · intramuscular every 3 months · 36 monthsAs given in this study (human).

    Source sentences

    Summary
    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.
    3 context sentences
    Summary · context
    Open-label, 36-month extension.
    Summary · context
    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.
    Summary · context
    Leuprolide acetate depot (11.25 or 30 mg) administered im every 3 months.

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 postedNCT00667446

Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

AbbVie (prior sponsor, Abbott)n = 72Dec 2008 to Jan 2013

Precocious · Leuprolide Acetate · Luteinizing Hormone (LH) · Gonadotrophin-releasing Hormone Agonist (GnRHa) · Tanner Staging · Depot Formulation · Suppression of LH · Central Precocious Puberty (CPP) · Gonadotrophin-releasing Hormone (GnRH) · Lupron · GnRH Analog · Pediatrics Central Precocious Puberty

Trial pageClinicalTrials.govUpdated 9 Jan 2014

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. 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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