[Efficacy and safety of triptorelin acetate microspheres for injection versus triptorelin acetate for injection in Chinese patients with endometriosis: a multicenter, randomized, double-blind, phase Ⅲ non-inferiority clinical trial].

Zhao AM, Wang Y, Yang WW, Liang ZQ, Shen FJ, Li CZ, Wei ZT, Sheng XJ, Yuan W, Li Q, Ming F, Zheng YH and 36 more

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Lu XY, Ye H, Li JJ, Lye B, Ruan HJ, Zhang YZ, Li YX, Li WR, Yang HK, Zheng YL, Dong XJ, Lu H, Hou SY, Yan P, Ge YQ, Kang JL, Wang LN, Zhang HY, Hu Y, Zhao RF, Wang YL, Zhang SY, Han LP, Sang L, Cui MH, Zhai JJ, Lu D, Zheng Y, Guo YZ, Chen ML, Sun LP, Lu J, Guo SJ, Zhang XH, Feng W, Yang LH

Zhonghua fu chan ke za zhi1 Jan 2026

PMID41611266DOI10.3760/cma.j.cn112141-20250421-00161PepBankPUB-41611266

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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 study14

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with endometriosis, left and right ovarian endometrioma diameters did not change significantly from baseline with standard triptorelin injection.
In plain wordsIn patients with endometriosis, ovarian endometrioma diameters did not change significantly during standard triptorelin treatment.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeOvarian endometrioma diameter (left and right) with standard injection
Study
n = 196
Analysis
Secondary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
Dose not stated · intramuscularAs given in this study (human).
Source sentences
Summary
In the control group, neither left nor right ovarian endometrioma diameters showed significant changes from baseline (all P>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
Report a problemFND-4161126613
02HumanRandomized controlled trialEfficacy outcome
In patients with endometriosis, right ovarian endometrioma diameter decreased from baseline at week 24 with triptorelin microspheres.
In plain wordsIn patients with endometriosis, right ovarian endometrioma diameter decreased during triptorelin microsphere treatment.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseRight ovarian endometrioma diameter with microspheres
Study
n: not reported in source
Analysis
Secondary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
Dose not stated · intramuscular · 6 doses, once every 4 weeksAs given in this study (human).
Source sentences
Summary
In the experimental group, only the diameter of the right ovarian endometrioma showed a significant decrease from baseline at week 24 post-treatment (P=0.016).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
Report a problemFND-4161126610
03HumanRandomized controlled trialEfficacy outcome
In patients with endometriosis, left ovarian endometrioma diameter did not decrease significantly with triptorelin microspheres at week 24.
In plain wordsIn patients with endometriosis, left ovarian endometrioma diameter did not decrease significantly during triptorelin microsphere treatment.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeLeft ovarian endometrioma diameter with microspheres
Study
n: not reported in source
Analysis
Secondary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
Dose not stated · intramuscular · 6 doses, once every 4 weeksAs given in this study (human).
Source sentences
Summary
In the experimental group, only the diameter of the right ovarian endometrioma showed a significant decrease from baseline at week 24 post-treatment (P=0.016).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
Report a problemFND-4161126611
04HumanRandomized controlled trialEfficacy outcome
In patients with endometriosis, left ovarian endometrioma diameter did not change significantly from baseline with standard triptorelin injection.
In plain wordsIn patients with endometriosis, left ovarian endometrioma diameter did not change significantly during standard triptorelin treatment.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeLeft ovarian endometrioma diameter with standard injection
Study
n: not reported in source
Analysis
Secondary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
Dose not stated · intramuscular · 6 doses, once every 4 weeksAs given in this study (human).
Source sentences
Summary
In the control group, neither left nor right ovarian endometrioma diameters showed significant changes from baseline (all P>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
Report a problemFND-4161126612

Studies that did not test the peptide alone10

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).

05HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, triptorelin microspheres met the non-inferiority criterion for estradiol suppression versus triptorelin acetate injection.
In plain wordsIn patients with endometriosis, triptorelin microspheres met the non-inferiority criterion for estradiol suppression versus standard triptorelin injection.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeEstradiol suppression at week 12
Study
n = 366
Comparator
triptorelin acetate for injection
Analysis
Primary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Measurements
Estradiol suppression
97.3%
microspheres
Estradiol suppression
98.4%
control
Rate difference, estradiol suppression
−1.1%
microspheres minus control
95% CI of rate difference
−4.8 to 2.3%
microspheres minus control
Source sentences
Summary
For the primary efficacy endpoint, the percentages of subjects with suppressed estradiol levels at week 12 in the experimental and control groups were 97.3% (177/182) and 98.4% (181/184), respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
The rate difference was -1.1% (95%CI: -4.8% to 2.3%), the lower limit of the 95%CI for the rate difference was greater than the non-inferiority margin of -10%.
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126601
06HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialSafety outcome
In patients with endometriosis, adverse drug reaction incidence was similar between triptorelin microspheres and standard injection.
In plain wordsIn patients with endometriosis, adverse drug reactions were similarly frequent with both triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeAdverse drug reactions
Study
n = 392
Comparator
triptorelin acetate for injection
Analysis
Secondary
Outcome group
Adverse events · Reproductive and sexual health
Measurements
Adverse drug reactions
77.6%
microspheres
Adverse drug reactions
78.6%
control
Source sentences
Summary
The overall incidence of adverse drug reactions was similar between the experimental and control groups [77.6% (152/196) vs 78.6% (154/196), respectively; P>0.05].
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126614
07HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, dysmenorrhea scores decreased from baseline with both triptorelin formulations, without significant between-group differences.
In plain wordsIn patients with endometriosis, menstrual pain scores decreased with both triptorelin formulations, without significant differences between them.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeDysmenorrhea VAS
Study
n: not reported in source
Comparator
triptorelin acetate for injection
Analysis
Secondary
Outcome group
Pain · Reproductive and sexual health
Source sentences
Summary
Compared to baseline, visual analog scale (VAS) scores for dysmenorrhea and non-menstrual pelvic pain decreased at all post-treatment time points in both groups, with no statistically significant differences between two groups (all P>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126602
08HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, non-menstrual pelvic pain decreased from baseline with both triptorelin formulations, without significant between-group differences.
In plain wordsIn patients with endometriosis, non-menstrual pelvic pain decreased with both triptorelin formulations, without significant differences between them.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeNon-menstrual pelvic pain VAS
Study
n: not reported in source
Comparator
triptorelin acetate for injection
Analysis
Secondary
Outcome group
Pain · Reproductive and sexual health
Source sentences
Summary
Compared to baseline, visual analog scale (VAS) scores for dysmenorrhea and non-menstrual pelvic pain decreased at all post-treatment time points in both groups, with no statistically significant differences between two groups (all P>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126603
09HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, amenorrhea rates did not differ significantly between triptorelin formulations at weeks 8, 12, and 24.
In plain wordsIn patients with endometriosis, amenorrhea rates were similar between triptorelin formulations.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeAmenorrhea rates
Study
n: not reported in source
Comparator
triptorelin acetate for injection
Analysis
Secondary
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Source sentences
Summary
No significant differences were observed in amenorrhea rates between two groups at week 8, 12, and 24 post-treatment (all P>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126607
10HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, estradiol decreased significantly from baseline with both triptorelin formulations, without significant between-group differences.
In plain wordsIn patients with endometriosis, estradiol decreased with both triptorelin formulations, without significant differences between them.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeEstradiol levels
Study
n: not reported in source
Comparator
triptorelin acetate for injection
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Source sentences
Summary
Estradiol, luteinizing hormone, and follicle stimulating hormone levels significantly decreased from baseline at all post-treatment time points in both groups (all PP>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126604
11HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, luteinizing hormone decreased significantly from baseline with both triptorelin formulations, without significant between-group differences.
In plain wordsIn patients with endometriosis, luteinizing hormone decreased with both triptorelin formulations, without significant differences between them.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeLuteinizing hormone levels
Study
n: not reported in source
Comparator
triptorelin acetate for injection
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Source sentences
Summary
Estradiol, luteinizing hormone, and follicle stimulating hormone levels significantly decreased from baseline at all post-treatment time points in both groups (all PP>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126605
12HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, follicle-stimulating hormone decreased significantly from baseline with both triptorelin formulations, without significant between-group differences.
In plain wordsIn patients with endometriosis, follicle-stimulating hormone decreased with both triptorelin formulations, without significant differences between them.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeFollicle-stimulating hormone levels
Study
n: not reported in source
Comparator
triptorelin acetate for injection
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Source sentences
Summary
Estradiol, luteinizing hormone, and follicle stimulating hormone levels significantly decreased from baseline at all post-treatment time points in both groups (all PP>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126606
13HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, menstruation recovered earlier after discontinuing triptorelin microspheres than after standard triptorelin injection.
In plain wordsIn patients with endometriosis, periods returned earlier after stopping triptorelin microspheres than after standard triptorelin injection.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseTime to menstruation recovery
Study
n: not reported in source
Comparator
triptorelin acetate for injection
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Source sentences
Summary
However, the time to menstruation recovery after drug discontinuation was significantly earlier in the experimental group than that in the control group (P=0.003).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126608
14HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialEfficacy outcome
In patients with endometriosis, CA125 decreased significantly from baseline with both triptorelin formulations, without significant between-group differences.
In plain wordsIn patients with endometriosis, CA125 decreased with both triptorelin formulations, without significant differences between them.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeCA125 levels
Study
n: not reported in source
Comparator
triptorelin acetate for injection
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Source sentences
Summary
Carbohydrate antigen 125 levels significantly decreased from baseline at week 12 and 24 post-treatment in both groups (all PP>0.05).
3 context sentences(design, population, supporting numbers)
Summary · context
A total of 392 patients with endometriosis were prospectively enrolled from 47 research centers across China between October 25, 2021, and February 14, 2023.
Summary · context
Participants were randomly assigned in a 1∶1 ratio to either the experimental group (n=196) or the control group (n=196).
Summary · context
Both groups received intramuscular injections of the respective drugs once every 4 weeks for a total of 6 doses.
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-4161126609

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 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.

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