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Study · Non-randomized trial · n = 36 · 2013

6 results

Random unstimulated pediatric luteinizing hormone levels are not reliable in the assessment of pubertal suppression during histrelin implant therapy.

Neely EK, Silverman LA, Geffner ME, Danoff TM, Gould E, Thornton PS

International journal of pediatric endocrinology2 Dec 2013Cited by 26 (Europe PMC)

PMID24295437 (opens in a new tab)PMCIDPMC4220797 (opens in a new tab)DOI10.1186/1687-9856-2013-20 (opens in a new tab)PepBankPUB-24295437
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Summary

BackgroundGonadotropin-releasing hormone agonist (GnRHa)-stimulated luteinizing hormone (LH) is the standard hormonal assessment for both diagnosis and therapeutic monitoring of children with central precocious puberty (CPP). Use of unstimulated (random) LH levels may be helpful in diagnosis and has gained popularity in monitoring GnRHa therapy despite lack of validation against stimulated values. The objective of this investigation was to assess the suitability of random LH for monitoring pubertal suppression during GnRHa treatment.MethodsData from a multi-year, multicenter, open-label trial of annual histrelin implants for CPP was used for our analysis. Children meeting clinical and hormonal criteria for CPP, either naïve to GnRHa therapy or previously treated with another GnRHa for at least 6 months who were being treated at academic pediatric centers were included in the study. Subjects received a single 50-mg subcutaneous histrelin implant annually until final explant at an age determined at the discretion of each investigator. Monitoring visits for physical examination and GnRHa-stimulation testing were performed at regular intervals. The main outcome measure was pubertal suppression during treatment defined by peak LH < 4 mIU/mL after GnRHa stimulation.ResultsDuring histrelin treatment, 36 children underwent a total of 308 monitoring GnRHa stimulation tests. Unstimulated and peak LH levels were positively correlated (r = 0.798), and both declined from the first to second year of treatment. Mean ± SD peak LH level during therapy was 0.62 ± 0.43 mIU/mL (range, 0.06-2.3), well below the normal prepubertal mean. Mean random LH was 0.35 ± 0.25 mIU/mL (range, 0.04-1.5), 10-fold higher than the normal prepubertal mean. The random LH levels were above the prepubertal upper threshold (<0.3 mIU/mL) in 48.4% of all tests and in 88.9% of subjects at some point during therapy.ConclusionsIn contrast with GnRHa-stimulated LH, unstimulated LH values frequently fail to demonstrate suppression to prepubertal values during GnRHa therapy for CPP, despite otherwise apparent pubertal suppression, and are thus unsuitable for therapeutic monitoring.Trial registrationClinicalTrial.gov NCT00779103.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In children receiving histrelin for CPP, mean peak LH was 0.62 ± 0.43 mIU/mL (range 0.06-2.3).

    In plain wordsIn children receiving histrelin for CPP, mean peak LH was 0.62 mIU/mL.

    Peptide
    Histrelin
    Outcome
    Not applicablePeak LH during therapy
    Study

    n = 36

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    50 mg annually · subcutaneousAs given in this study (human).

    Measurements

    Mean peak LH during therapy
    0.62 mIU/mL
    SD 0.43, 36 children
    Peak LH range during therapy
    0.06 to 2.3 mIU/mL
    range 0.06 to 2.3

    Source sentences

    Summary
    Mean ± SD peak LH level during therapy was 0.62 ± 0.43 mIU/mL (range, 0.06-2.3), well below the normal prepubertal mean.
    2 context sentences
    Summary · context
    Data from a multi-year, multicenter, open-label trial of annual histrelin implants for CPP was used for our analysis.
    Summary · context
    Subjects received a single 50-mg subcutaneous histrelin implant annually until final explant at an age determined at the discretion of each investigator.
  2. 02HumanNon-randomized trialEfficacy outcome

    In children receiving histrelin for CPP, mean random LH was 0.35 ± 0.25 mIU/mL (range 0.04-1.5), 10-fold the normal prepubertal mean.

    In plain wordsIn children receiving histrelin for CPP, mean random LH was 10-fold the normal prepubertal mean.

    Peptide
    Histrelin
    Outcome
    IncreaseRandom LH during therapy
    Study

    n = 36

    Comparator
    Normal prepubertal mean
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    50 mg annually · subcutaneousAs given in this study (human).

    Measurements

    Mean random LH during therapy
    0.35 mIU/mL
    SD 0.25, 36 children
    Random LH range during therapy
    0.04 to 1.5 mIU/mL
    range 0.04 to 1.5
    Mean random LH versus normal prepubertal mean
    10 fold
    higher than normal prepubertal mean

    Source sentences

    Summary
    Mean random LH was 0.35 ± 0.25 mIU/mL (range, 0.04-1.5), 10-fold higher than the normal prepubertal mean.
    2 context sentences
    Summary · context
    Data from a multi-year, multicenter, open-label trial of annual histrelin implants for CPP was used for our analysis.
    Summary · context
    Subjects received a single 50-mg subcutaneous histrelin implant annually until final explant at an age determined at the discretion of each investigator.
  3. 03HumanNon-randomized trialEfficacy outcome

    During histrelin treatment for CPP, random LH exceeded the prepubertal threshold in 48.4% of tests.

    In plain wordsDuring histrelin treatment for CPP, random LH exceeded the prepubertal threshold in 48.4% of tests.

    Peptide
    Histrelin
    Outcome
    Not applicableRandom LH above threshold per test
    Study

    n = 36

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    50 mg annually · subcutaneousAs given in this study (human).

    Measurements

    Tests with random LH above prepubertal threshold
    48.4%
    all tests; threshold <0.3 mIU/mL

    Source sentences

    Summary
    The random LH levels were above the prepubertal upper threshold (<0.3 mIU/mL) in 48.4% of all tests and in 88.9% of subjects at some point during therapy.
    2 context sentences
    Summary · context
    Data from a multi-year, multicenter, open-label trial of annual histrelin implants for CPP was used for our analysis.
    Summary · context
    Subjects received a single 50-mg subcutaneous histrelin implant annually until final explant at an age determined at the discretion of each investigator.
  4. 04HumanNon-randomized trialEfficacy outcome

    During histrelin treatment for CPP, random LH exceeded the prepubertal threshold in 88.9% of subjects at some point.

    In plain wordsDuring histrelin treatment for CPP, 88.9% of children had random LH above the prepubertal threshold at some point.

    Peptide
    Histrelin
    Outcome
    Not applicableRandom LH above threshold per subject
    Study

    n = 36

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    50 mg annually · subcutaneousAs given in this study (human).

    Measurements

    Subjects with random LH above prepubertal threshold at some point
    88.9%
    during therapy; threshold <0.3 mIU/mL

    Source sentences

    Summary
    The random LH levels were above the prepubertal upper threshold (<0.3 mIU/mL) in 48.4% of all tests and in 88.9% of subjects at some point during therapy.
    2 context sentences
    Summary · context
    Data from a multi-year, multicenter, open-label trial of annual histrelin implants for CPP was used for our analysis.
    Summary · context
    Subjects received a single 50-mg subcutaneous histrelin implant annually until final explant at an age determined at the discretion of each investigator.
  5. 05HumanNon-randomized trialEfficacy outcome

    In children receiving histrelin for CPP, unstimulated LH declined from the first to second treatment year.

    In plain wordsIn children receiving histrelin for CPP, unstimulated LH declined from the first to second year.

    Peptide
    Histrelin
    Outcome
    DecreaseUnstimulated LH over time
    Study

    n: not reported in source

    Comparator
    First treatment year
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    50 mg annually · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Unstimulated and peak LH levels were positively correlated (r = 0.798), and both declined from the first to second year of treatment.
    2 context sentences
    Summary · context
    Data from a multi-year, multicenter, open-label trial of annual histrelin implants for CPP was used for our analysis.
    Summary · context
    Subjects received a single 50-mg subcutaneous histrelin implant annually until final explant at an age determined at the discretion of each investigator.
  6. 06HumanNon-randomized trialEfficacy outcome

    In children receiving histrelin for CPP, peak LH declined from the first to second treatment year.

    In plain wordsIn children receiving histrelin for CPP, peak LH declined from the first to second year.

    Peptide
    Histrelin
    Outcome
    DecreasePeak LH over time
    Study

    n: not reported in source

    Comparator
    First treatment year
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    50 mg annually · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Unstimulated and peak LH levels were positively correlated (r = 0.798), and both declined from the first to second year of treatment.
    2 context sentences
    Summary · context
    Data from a multi-year, multicenter, open-label trial of annual histrelin implants for CPP was used for our analysis.
    Summary · context
    Subjects received a single 50-mg subcutaneous histrelin implant annually until final explant at an age determined at the discretion of each investigator.

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 postedNCT00779103

Histrelin Subcutaneous Implant in Children With Central Precocious Puberty

Endo USA Inc., a Keenova Therapeutics Companyn = 36Sept 2004 to Apr 2012

Central Precocious Puberty

Trial pageClinicalTrials.govUpdated 8 Jan 2021

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, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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