Efficacy and safety of histrelin subdermal implant in children with central precocious puberty: a multicenter trial.

Eugster EA, Clarke W, Kletter GB, Lee PA, Neely EK, Reiter EO, Saenger P, Shulman D, Silverman L, Flood L, Gray W, Tierney D

The Journal of clinical endocrinology and metabolism27 Feb 2007Cited by 71 (Europe PMC)

PMID17327379DOI10.1210/jc.2006-2479PepBankPUB-17327379

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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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanNon-randomized trialSafety outcome
No significant adverse events occurred in children receiving histrelin implants.
In plain wordsNo significant adverse events occurred in children receiving histrelin implants.
Peptide
Histrelin
Outcome
Not applicableSignificant adverse events
Study
n = 36
Outcome group
Adverse events · Whole body
Studied dose
50 mg · subcutaneous implant · 1 yearAs given in this study (human).
Source sentences
Summary
No significant adverse events occurred.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, open-label, prospective study of 1-yr duration.
Summary · context
A 50-mg histrelin implant was inserted sc in the inner upper arm.
Report a problemFND-1732737906
02HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, suppression of peak LH and sex steroid levels was maintained throughout the one-year histrelin implant study.
In plain wordsIn children with central precocious puberty, suppression of LH and sex hormones was maintained during one year of histrelin implant treatment.
Peptide
Histrelin
Outcome
Not applicableMaintenance of peak LH and sex steroid suppression
Study
n = 36
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subcutaneous implant · 1 yearAs given in this study (human).
Source sentences
Summary
Suppression was maintained throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
The subdermal histrelin implant achieves and maintains excellent suppression of peak LH and sex steroid levels for 1 yr in children with CPP.
Summary · context
This was a phase III, open-label, prospective study of 1-yr duration.
Summary · context
A 50-mg histrelin implant was inserted sc in the inner upper arm.
Report a problemFND-1732737907
03HumanNon-randomized trialEfficacy outcome
In naïve children with CPP, histrelin reduced peak LH from 28.2 to 0.8 mIU/ml by 1 month (P < 0.0001).
In plain wordsIn treatment-naïve children with CPP, histrelin reduced peak LH by 1 month.
Peptide
Histrelin
Outcome
DecreasePeak LH in naïve children
Study
n = 20
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subcutaneous implantAs given in this study (human).
Measurements
Peak LH at baseline (mean, SD 19.97)
28.2 mIU/ml
naive children
Peak LH by 1 month (mean, SD 0.39)
0.8 mIU/ml
naive children
Source sentences
Summary
By 1 month, peak LH fell from 28.2 +/- 19.97 (naive) to 0.8 +/- 0.39 mIU/ml (P < 0.0001) and from 2.1 +/- 2.15 (previously treated) to 0.5 +/- 0.32 mIU/ml (P < 0.0056).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, open-label, prospective study of 1-yr duration.
Summary · context
A 50-mg histrelin implant was inserted sc in the inner upper arm.
Report a problemFND-1732737901
04HumanNon-randomized trialEfficacy outcome
In previously treated children with CPP, histrelin reduced peak LH from 2.1 to 0.5 mIU/ml by 1 month (P < 0.0056).
In plain wordsIn previously treated children with CPP, histrelin reduced peak LH by 1 month.
Peptide
Histrelin
Outcome
DecreasePeak LH in previously treated children
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subcutaneous implantAs given in this study (human).
Measurements
Peak LH at baseline (mean, SD 2.15)
2.1 mIU/ml
previously treated children
Peak LH by 1 month (mean, SD 0.32)
0.5 mIU/ml
previously treated children
Source sentences
Summary
By 1 month, peak LH fell from 28.2 +/- 19.97 (naive) to 0.8 +/- 0.39 mIU/ml (P < 0.0001) and from 2.1 +/- 2.15 (previously treated) to 0.5 +/- 0.32 mIU/ml (P < 0.0056).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, open-label, prospective study of 1-yr duration.
Summary · context
A 50-mg histrelin implant was inserted sc in the inner upper arm.
Report a problemFND-1732737902
05HumanNon-randomized trialEfficacy outcome
In naïve girls with CPP, histrelin reduced estradiol from 24.5 to 5.9 pg/ml (P = 0.0016).
In plain wordsIn treatment-naïve girls with CPP, histrelin reduced estradiol.
Peptide
Histrelin
Outcome
DecreaseEstradiol in naïve girls
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subcutaneous implantAs given in this study (human).
Measurements
Estradiol before suppression (mean, SD 22.27)
24.5 pg/ml
naive children
Estradiol after suppression (mean, SD 2.37)
5.9 pg/ml
naive children
Source sentences
Summary
Estradiol suppressed from 24.5 +/- 22.27 (naive) to 5.9 +/- 2.37 pg/ml (P = 0.0016) and remained suppressed in previously treated subjects, as did testosterone.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase III, open-label, prospective study of 1-yr duration.
Summary · context
A 50-mg histrelin implant was inserted sc in the inner upper arm.
Report a problemFND-1732737903
06HumanNon-randomized trialEfficacy outcome
In previously treated girls with CPP, estradiol remained suppressed during histrelin treatment.
In plain wordsIn previously treated girls with CPP, estradiol remained suppressed during histrelin treatment.
Peptide
Histrelin
Outcome
Not applicableEstradiol suppression in previously treated girls
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subcutaneous implant · 1 yearAs given in this study (human).
Source sentences
Summary
Estradiol suppressed from 24.5 +/- 22.27 (naive) to 5.9 +/- 2.37 pg/ml (P = 0.0016) and remained suppressed in previously treated subjects, as did testosterone.
3 context sentences(design, population, supporting numbers)
Summary · context
Suppression was maintained throughout the study.
Summary · context
This was a phase III, open-label, prospective study of 1-yr duration.
Summary · context
A 50-mg histrelin implant was inserted sc in the inner upper arm.
Report a problemFND-1732737904
07HumanNon-randomized trialEfficacy outcome
In previously treated boys with CPP, testosterone remained suppressed during histrelin treatment.
In plain wordsIn previously treated boys with CPP, testosterone remained suppressed during histrelin treatment.
Peptide
Histrelin
Outcome
Not applicableTestosterone suppression
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
50 mg · subcutaneous implant · 1 yearAs given in this study (human).
Source sentences
Summary
Estradiol suppressed from 24.5 +/- 22.27 (naive) to 5.9 +/- 2.37 pg/ml (P = 0.0016) and remained suppressed in previously treated subjects, as did testosterone.
3 context sentences(design, population, supporting numbers)
Summary · context
Suppression was maintained throughout the study.
Summary · context
This was a phase III, open-label, prospective study of 1-yr duration.
Summary · context
A 50-mg histrelin implant was inserted sc in the inner upper arm.
Report a problemFND-1732737905

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

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 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:37 UTC
Study data updated · source update from Europe PMC
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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