Pharmacodynamic equivalence of a decapeptyl 3-month SR formulation with the 28-day SR formulation in patients with advanced prostate cancer.

Teillac P, Heyns CF, Kaisary AV, Bouchot O, Blumberg J

Hormone research19 Oct 2004Cited by 18 (Europe PMC)

PMID15499224DOI10.1159/000081629PepBankPUB-15499224

Publisher page PubMedAsk about this study

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

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone7

In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Triptorelin (Trelstar, Decapeptyl).

01HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In advanced prostate cancer, chemical castration rates were equivalent with the three-month and 28-day triptorelin formulations.
In plain wordsIn advanced prostate cancer, chemical castration rates were equivalent with the three-month and 28-day triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeChemical castration rate
Study
n = 131
Comparator
28-day triptorelin SR formulation
Outcome group
Sex hormones and fertility · Endocrine and hormones
Measurements
Chemical castration rate at D84
98%
3-month formulation (n = 63)
Chemical castration rate at D84
96%
28-day formulation (n = 68)
Source sentences
Summary
Chemical castration rates were 98 and 96% in the 3-month and 28-day formulation groups, respectively, with confidence interval (two-sided 94.2% CI) of [-8.1%; 9.6%].
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68).
In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Triptorelin (Trelstar, Decapeptyl).
Report a problemFND-1549922401
02HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In advanced prostate cancer, time to chemical castration did not differ significantly between the three-month and 28-day triptorelin formulations.
In plain wordsIn advanced prostate cancer, time to chemical castration did not differ significantly between the three-month and 28-day triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeTime to chemical castration
Study
n = 131
Comparator
28-day triptorelin SR formulation
Outcome group
Sex hormones and fertility · Endocrine and hormones
Measurements
Median time to chemical castration
18.8 days
3-month formulation
Median time to chemical castration
18.5 days
28-day formulation
Source sentences
Summary
Median times to reach chemical castration were 18.8 and 18.5 days (p = 0.86, log rank), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68).
In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Triptorelin (Trelstar, Decapeptyl).
Report a problemFND-1549922402
03HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In advanced prostate cancer, mean peak testosterone levels met equivalence criteria for the two triptorelin formulations.
In plain wordsIn advanced prostate cancer, mean peak testosterone levels met equivalence criteria for the two triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeTestosterone peak plasma level
Study
n = 131
Comparator
28-day triptorelin SR formulation
Outcome group
Sex hormones and fertility · Endocrine and hormones
Source sentences
Summary
Ratios for mean peak plasma levels and AUC(91) of the two formulations for both testosterone and LH fell within the [0.80; 1.25] equivalence interval.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68).
In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Triptorelin (Trelstar, Decapeptyl).
Report a problemFND-1549922403
04HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In advanced prostate cancer, testosterone exposure met equivalence criteria for the two triptorelin formulations.
In plain wordsIn advanced prostate cancer, testosterone exposure met equivalence criteria for the two triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeTestosterone AUC
Study
n = 131
Comparator
28-day triptorelin SR formulation
Outcome group
Sex hormones and fertility · Endocrine and hormones
Source sentences
Summary
Ratios for mean peak plasma levels and AUC(91) of the two formulations for both testosterone and LH fell within the [0.80; 1.25] equivalence interval.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68).
In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Triptorelin (Trelstar, Decapeptyl).
Report a problemFND-1549922404
05HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In advanced prostate cancer, mean peak LH levels met equivalence criteria for the two triptorelin formulations.
In plain wordsIn advanced prostate cancer, mean peak LH levels met equivalence criteria for the two triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeLH peak plasma level
Study
n = 131
Comparator
28-day triptorelin SR formulation
Outcome group
Sex hormones and fertility · Endocrine and hormones
Source sentences
Summary
Ratios for mean peak plasma levels and AUC(91) of the two formulations for both testosterone and LH fell within the [0.80; 1.25] equivalence interval.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68).
In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Triptorelin (Trelstar, Decapeptyl).
Report a problemFND-1549922405
06HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In advanced prostate cancer, LH exposure met equivalence criteria for the two triptorelin formulations.
In plain wordsIn advanced prostate cancer, LH exposure met equivalence criteria for the two triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeLH AUC
Study
n = 131
Comparator
28-day triptorelin SR formulation
Outcome group
Sex hormones and fertility · Endocrine and hormones
Source sentences
Summary
Ratios for mean peak plasma levels and AUC(91) of the two formulations for both testosterone and LH fell within the [0.80; 1.25] equivalence interval.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68).
In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Triptorelin (Trelstar, Decapeptyl).
Report a problemFND-1549922406
07HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In advanced prostate cancer, PSA decreases did not differ significantly between the three-month and 28-day triptorelin formulations.
In plain wordsIn advanced prostate cancer, PSA decreases did not differ significantly between the three-month and 28-day triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changePSA decrease
Study
n = 131
Comparator
28-day triptorelin SR formulation
Outcome group
Tumor growth · Cancer
Measurements
Mean PSA decrease from baseline at D91
91%
3-month formulation
Mean PSA decrease from baseline at D91
91.7%
28-day formulation
Source sentences
Summary
Mean PSA decreases from baseline at D91 were 91.0 and 91.7%, respectively (p = 0.73).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with documented locally advanced or metastatic prostate cancer were randomized to receive one injection of the 3-month formulation (n = 63) or three injections at 28-day intervals of the 28-day formulation (n = 68).
In this study, Triptorelin (Trelstar, Decapeptyl) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Triptorelin (Trelstar, Decapeptyl).
Report a problemFND-1549922407

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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

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