Long-Term Continuous Suppression With Once-Yearly Histrelin Subcutaneous Implants for the Treatment of Central Precocious Puberty: A Final Report of a Phase 3 Multicenter Trial.

Silverman LA, Neely EK, Kletter GB, Lewis K, Chitra S, Terleckyj O, Eugster EA

The Journal of clinical endocrinology and metabolism24 Mar 2015Cited by 44 (Europe PMC)

PMID25803268PMCIDPMC4504932DOI10.1210/jc.2014-3031PepBankPUB-25803268

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.

01HumanNon-randomized trialEfficacy outcome
In treatment-naive children with central precocious puberty, histrelin maintained hormonal suppression throughout the study.
In plain wordsIn previously untreated children with central precocious puberty, histrelin maintained hormone suppression throughout the study.
Peptide
Histrelin
Outcome
Not applicableHormonal suppression in treatment-naive children
Study
n = 20
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · up to 6 yearsAs given in this study (human).
Source sentences
Summary
Hormonal suppression was maintained throughout the study in patients who had prior GnRHa therapy (n = 16) and in treatment-naive patients (n = 20).
3 context sentences(design, population, supporting numbers)
Summary · context
Hormone levels and auxologic parameters were measured periodically for up to 6 years of treatment and up to 1 year of posttreatment follow-up.
Summary · context
This was a phase 3, prospective, open-label study.
Summary · context
Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.
Report a problemFND-2580326802
02HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty and prior GnRHa therapy, histrelin maintained hormonal suppression throughout the study.
In plain wordsIn children previously treated for central precocious puberty, histrelin maintained hormone suppression throughout the study.
Peptide
Histrelin
Outcome
Not applicableHormonal suppression after prior GnRHa therapy
Study
n = 16
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · subcutaneous · up to 6 yearsAs given in this study (human).
Source sentences
Summary
Hormonal suppression was maintained throughout the study in patients who had prior GnRHa therapy (n = 16) and in treatment-naive patients (n = 20).
3 context sentences(design, population, supporting numbers)
Summary · context
Hormone levels and auxologic parameters were measured periodically for up to 6 years of treatment and up to 1 year of posttreatment follow-up.
Summary · context
This was a phase 3, prospective, open-label study.
Summary · context
Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.
Report a problemFND-2580326801
03HumanNon-randomized trialEfficacy outcome
In treatment-naive children receiving histrelin, bone age to chronological age ratio fell from 1.417 at baseline to 1.18 at 48 months (P < .01).
In plain wordsIn previously untreated children receiving histrelin, bone age relative to chronological age decreased from baseline at 48 months.
Peptide
Histrelin
Outcome
DecreaseBone age to chronological age ratio at 48 months
Study
n = 8
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Bone age to chronological age ratio at baseline
1.417 ratio
treatment-naive children, n = 20
Bone age to chronological age ratio at 48 months
1.18 ratio
treatment-naive children, n = 8
Source sentences
Summary
Bone age to chronological age ratio decreased from 1.417 (n = 20) at baseline to 1.18 (n = 8) at 48 months in treatment-naive children (P < .01).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 3, prospective, open-label study.
Summary · context
Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.
Report a problemFND-2580326803
04HumanNon-randomized trialEfficacy outcome
In girls receiving histrelin, predicted adult height increased from 151.9 cm at baseline to 166.5 cm at month 60 (P < .05).
In plain wordsIn girls receiving histrelin, predicted adult height increased from baseline at month 60.
Peptide
Histrelin
Outcome
IncreasePredicted adult height in girls at month 60
Study
n = 6
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Predicted adult height at baseline
151.9 cm
girls, n = 6
Predicted adult height at month 60
166.5 cm
girls, n = 6
Source sentences
Summary
Predicted adult height in girls increased from 151.9 cm at baseline to 166.5 cm at month 60 (n = 6; P < .05), with a 10.7-cm height gain observed among treatment-naive children (n = 5).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 3, prospective, open-label study.
Summary · context
Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.
Report a problemFND-2580326804
05HumanNon-randomized trialEfficacy outcome
In treatment-naive children receiving histrelin, the study observed a 10.7-cm predicted height gain.
In plain wordsIn previously untreated children receiving histrelin, predicted height increased by 10.7 cm.
Peptide
Histrelin
Outcome
IncreasePredicted height gain in treatment-naive children
Study
n = 5
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Height gain
10.7 cm
treatment-naive children, n = 5
Source sentences
Summary
Predicted adult height in girls increased from 151.9 cm at baseline to 166.5 cm at month 60 (n = 6; P < .05), with a 10.7-cm height gain observed among treatment-naive children (n = 5).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 3, prospective, open-label study.
Summary · context
Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.
Report a problemFND-2580326805
06HumanNon-randomized trialSafety outcome
In children receiving histrelin for central precocious puberty, no adverse effect on growth was observed with hormonal suppression.
In plain wordsIn children receiving histrelin, the study observed no adverse effect on growth.
Peptide
Histrelin
Outcome
Not applicableAdverse effect on growth
Study
n: not reported in source
Outcome group
Adverse events · Musculoskeletal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
No adverse effect on growth or recovery of the hypothalamic-pituitary-gonadal axis was observed with hormonal suppression.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 3, prospective, open-label study.
Summary · context
Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.
Report a problemFND-2580326806
07HumanNon-randomized trialSafety outcome
In children receiving histrelin, no adverse effect on hypothalamic-pituitary-gonadal axis recovery was observed with hormonal suppression.
In plain wordsIn children receiving histrelin, the study observed no adverse effect on recovery of the reproductive hormone system.
Peptide
Histrelin
Outcome
Not applicableRecovery of hypothalamic-pituitary-gonadal axis
Study
n: not reported in source
Outcome group
Adverse events · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
No adverse effect on growth or recovery of the hypothalamic-pituitary-gonadal axis was observed with hormonal suppression.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 3, prospective, open-label study.
Summary · context
Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.
Report a problemFND-2580326807
08HumanNon-randomized trialSafety outcome
In children with central precocious puberty, the histrelin implant was generally well tolerated during long-term therapy.
In plain wordsIn children with central precocious puberty, the histrelin implant was generally well tolerated during long-term treatment.
Peptide
Histrelin
Outcome
Not applicableLong-term tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
The histrelin implant was generally well tolerated during long-term therapy.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase 3, prospective, open-label study.
Summary · context
Thirty-six children with CPP who participated in a phase 3, open-label study and required further GnRHa therapy were eligible to continue treatment receiving a new implant upon removal of the prior 12-month histrelin implant during a long-term extension phase.
Report a problemFND-2580326808

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 page ClinicalTrials.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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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