Three-month sustained-release triptorelin (11.25 mg) in the treatment of central precocious puberty.

Carel JC, Blumberg J, Seymour C, Adamsbaum C, Lahlou N

European journal of endocrinology1 Jan 2006Cited by 43 (Europe PMC)

PMID16382000DOI10.1530/eje.1.02056PepBankPUB-16382000

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 study10

10 results from studies that gave the peptide. 10 results from people.

01HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, triptorelin achieved stimulated peak LH at or below 3 IU/l in 85% at month 3.
In plain wordsIn children with early puberty, triptorelin suppressed stimulated LH to the target in 85% at month 3.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseLH suppression at month 3
Study
n = 62
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Measurements
LH suppression response
85%
month 3
Responders
53 children
month 3
Source sentences
Summary
GnRH-stimulated peak LH < or = 3 IU/l, the main efficacy criterion, was met in 53 out of 62 (85%), 60 out of 62 (97%) and 56 out of 59 (95%) of the children at Months 3, 6 and 12 respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200001
02HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, triptorelin achieved stimulated peak LH at or below 3 IU/l in 97% at month 6.
In plain wordsIn children with early puberty, triptorelin suppressed stimulated LH to the target in 97% at month 6.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseLH suppression at month 6
Study
n = 62
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Measurements
LH suppression response
97%
month 6
Responders
60 children
month 6
Source sentences
Summary
GnRH-stimulated peak LH < or = 3 IU/l, the main efficacy criterion, was met in 53 out of 62 (85%), 60 out of 62 (97%) and 56 out of 59 (95%) of the children at Months 3, 6 and 12 respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200002
03HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, triptorelin achieved stimulated peak LH at or below 3 IU/l in 95% at month 12.
In plain wordsIn children with early puberty, triptorelin suppressed stimulated LH to the target in 95% at month 12.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseLH suppression at month 12
Study
n = 59
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Measurements
LH suppression response
95%
month 12
Responders
56 children
month 12
Source sentences
Summary
GnRH-stimulated peak LH < or = 3 IU/l, the main efficacy criterion, was met in 53 out of 62 (85%), 60 out of 62 (97%) and 56 out of 59 (95%) of the children at Months 3, 6 and 12 respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200003
04HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, serum FSH significantly decreased during triptorelin treatment.
In plain wordsIn children with early puberty, serum FSH fell significantly during triptorelin treatment.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseSerum FSH
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Source sentences
Summary
Serum FSH and sex steroids were also significantly reduced, while pubertal development regressed in most patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200004
05HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, serum sex steroids significantly decreased during triptorelin treatment.
In plain wordsIn children with early puberty, sex steroid levels fell significantly during triptorelin treatment.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseSerum sex steroids
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Source sentences
Summary
Serum FSH and sex steroids were also significantly reduced, while pubertal development regressed in most patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200005
06HumanNon-randomized trialEfficacy outcome
In children with central precocious puberty, pubertal development regressed in most patients during triptorelin treatment.
In plain wordsIn children with early puberty, pubertal development regressed in most patients during triptorelin treatment.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreasePubertal development
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Source sentences
Summary
Serum FSH and sex steroids were also significantly reduced, while pubertal development regressed in most patients.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200006
07HumanNon-randomized trialPharmacokinetics
In children with central precocious puberty, mean residual triptorelin levels remained stable from month 3 through month 12.
In plain wordsIn children with early puberty, residual triptorelin levels remained stable from month 3 through month 12.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeResidual triptorelin levels
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Source sentences
Summary
Mean residual triptorelin levels were stable from Month 3 through to Month 12.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200007
08HumanNon-randomized trialSafety outcome
The triptorelin depot was well tolerated in children with central precocious puberty.
In plain wordsChildren with early puberty tolerated the triptorelin depot well.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableOverall tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Source sentences
Summary
The triptorelin 3-month depot was well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200008
09HumanNon-randomized trialSafety outcome
In children with central precocious puberty, severe injection pain occurred on one occasion during triptorelin treatment.
In plain wordsIn children with early puberty, severe injection pain occurred once during triptorelin treatment.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableSevere injection pain
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Measurements
Severe injection pain
1 instance
whole study
Source sentences
Summary
Severe injection pain was experienced in only one instance.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200009
10HumanNon-randomized trialSafety outcome
Five girls receiving triptorelin had mild-to-moderate or severe withdrawal bleeding, with severe bleeding in one girl.
In plain wordsIn children with early puberty, five girls had withdrawal bleeding during triptorelin treatment, and one of them had severe bleeding.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableWithdrawal bleeding
Study
n: not reported in source
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
11.25 mg every 3 months · 12 monthsAs given in this study (human).
Measurements
Girls with withdrawal bleeding
5 girls
mild-to-moderate or severe
Girls with severe withdrawal bleeding
1 girl
severe
Source sentences
Summary
Five girls experienced mild-to-moderate or severe (one girl) withdrawal bleeding.
2 context sentences(design, population, supporting numbers)
Summary · context
The triptorelin 11.25 mg 3-month depot, currently used in adult indications, had not previously been evaluated in CPP.
Summary · context
This was a multicenter, open-label, 12 month trial conducted in 64 CPP children (54 girls and 10 boys), treated quarterly.
Report a problemFND-1638200010

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 not yet recruiting · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 4NCT06487143

Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityn = 134est. 1 Jul 2024 to est. 30 Dec 2026

Central Precocious Puberty

Trial page ClinicalTrials.govUpdated 5 Jul 2024

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
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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