Efficacy and safety of diphereline 11.25 mg, microrelin 11.25 mg, and microrelin 3.75 mg in premenopausal patients with breast cancer: a non-inferiority randomized clinical trial.

Najafi S, Ansari M, Omidi Z, Olfatbakhsh A, Moghadam S, Hashemi EO, Najafi N, Haghighat S

BMC cancer10 Nov 2023

PMID37950162PMCIDPMC10638790DOI10.1186/s12885-023-11614-7PepBankPUB-37950162

Summary

BackgroundDiphereline is a Gonadotropin-Releasing Hormone agonist commonly used in patients with breast cancer. This study aimed to compare the efficacy and safety of one-month and three-month Microrelin injections produced by Homa Pharmed Company with three-month Diphereline injections manufactured by IPSEN, France.MethodsThe study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy. The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg). The participants' menopausal symptoms, estradiol, and FSH serum levels were recorded in three-month intervals for one year. The efficacy of each medication and its side effects were compared among the three groups by statistical analysis during the one-year follow-up.ResultsThe study included 133 patients with breast cancer. A decreasing trend in the serum levels of FSH and estradiol and an increasing trend of menopausal symptoms were recorded during the study. No specific side effects leading to drug disruption, hospitalization, or exclusion from the study were observed. Adjusting the effect of study group and time showed no significant changes in estradiol levels between groups B (p = 0.506) and C (p = 0.607) and group A. Also, serum FSH changes between groups B (p = 0.132) and C (p = 0.104) compared to group A were not significant. Moreover, the menopausal symptoms during the one-year follow-up did not significantly increase in group B (p = 0.108) and C (p = 0.113) compared to group A.ConclusionsIt can be concluded that injections of both Microrelin 11.25 mg and 3.75 mg, produced by Homa Pharmed, Iran, are non-inferior in terms of effectiveness and incidence of menopausal symptoms compared to Diphereline, manufactured by IPSEN, France.Trial registrationIRCT.ir, IRCT20201227049847N1; Registered on 09/01/2021.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study10

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In women with breast cancer, estradiol changes did not differ between Microrelin 11.25 mg and Diphereline 11.25 mg.
In plain wordsIn women with breast cancer, estradiol changes were similar with Microrelin 11.25 mg and Diphereline 11.25 mg.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeEstradiol, Microrelin 11.25 mg versus Diphereline
Study
n: not reported in source
Comparator
Diphereline 11.25 mg
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mgAs given in this study (human).
Source sentences
Summary
Adjusting the effect of study group and time showed no significant changes in estradiol levels between groups B (p = 0.506) and C (p = 0.607) and group A.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
Show in the study text Report a problemFND-3795016205
02HumanRandomized controlled trialEfficacy outcome
In women with breast cancer, estradiol changes did not differ between Microrelin 3.75 mg and Diphereline 11.25 mg.
In plain wordsIn women with breast cancer, estradiol changes were similar with Microrelin 3.75 mg and Diphereline 11.25 mg.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeEstradiol, Microrelin 3.75 mg versus Diphereline
Study
n: not reported in source
Comparator
Diphereline 11.25 mg
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mgAs given in this study (human).
Source sentences
Summary
Adjusting the effect of study group and time showed no significant changes in estradiol levels between groups B (p = 0.506) and C (p = 0.607) and group A.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
Show in the study text Report a problemFND-3795016206
03HumanRandomized controlled trialEfficacy outcome
In women with breast cancer, FSH changes did not differ between Microrelin 11.25 mg and Diphereline 11.25 mg.
In plain wordsIn women with breast cancer, FSH changes were similar with Microrelin 11.25 mg and Diphereline 11.25 mg.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeFSH, Microrelin 11.25 mg versus Diphereline
Study
n: not reported in source
Comparator
Diphereline 11.25 mg
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mgAs given in this study (human).
Source sentences
Summary
Also, serum FSH changes between groups B (p = 0.132) and C (p = 0.104) compared to group A were not significant.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
Show in the study text Report a problemFND-3795016207
04HumanRandomized controlled trialEfficacy outcome
In women with breast cancer, FSH changes did not differ between Microrelin 3.75 mg and Diphereline 11.25 mg.
In plain wordsIn women with breast cancer, FSH changes were similar with Microrelin 3.75 mg and Diphereline 11.25 mg.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeFSH, Microrelin 3.75 mg versus Diphereline
Study
n: not reported in source
Comparator
Diphereline 11.25 mg
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
11.25 mg · injectionAs given in this study (human).
Source sentences
Summary
Also, serum FSH changes between groups B (p = 0.132) and C (p = 0.104) compared to group A were not significant.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
Show in the study text Report a problemFND-3795016208
05HumanRandomized controlled trialSafety outcome
In women with breast cancer, menopausal symptoms did not significantly increase with Microrelin 11.25 mg versus Diphereline 11.25 mg.
In plain wordsIn women with breast cancer, menopausal symptoms did not significantly increase with Microrelin 11.25 mg compared with Diphereline 11.25 mg.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeMenopausal symptoms, Microrelin 11.25 mg versus Diphereline
Study
n: not reported in source
Comparator
Diphereline 11.25 mg
Outcome group
Adverse events · Endocrine and hormones
Studied dose
11.25 mg · injectionAs given in this study (human).
Source sentences
Summary
Moreover, the menopausal symptoms during the one-year follow-up did not significantly increase in group B (p = 0.108) and C (p = 0.113) compared to group A.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
Show in the study text Report a problemFND-3795016209
06HumanRandomized controlled trialSafety outcome
In women with breast cancer, menopausal symptoms did not significantly increase with Microrelin 3.75 mg versus Diphereline 11.25 mg.
In plain wordsIn women with breast cancer, menopausal symptoms did not significantly increase with Microrelin 3.75 mg compared with Diphereline 11.25 mg.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
No significant changeMenopausal symptoms, Microrelin 3.75 mg versus Diphereline
Study
n: not reported in source
Comparator
Diphereline 11.25 mg
Outcome group
Adverse events · Endocrine and hormones
Studied dose
11.25 mg · injectionAs given in this study (human).
Source sentences
Summary
Moreover, the menopausal symptoms during the one-year follow-up did not significantly increase in group B (p = 0.108) and C (p = 0.113) compared to group A.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
Show in the study text Report a problemFND-3795016210

Studies that did not test the peptide alone4

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).

07HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialActivity measurement
In premenopausal women with breast cancer, serum FSH decreased during the study across the three groups (Diphereline 11.25 mg and two Microrelin regimens).
In plain wordsIn women with breast cancer, FSH fell during the study across all three treatment groups.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseFSH trend across formulations
Study
n = 133
Outcome group
Sex hormones and fertility · Endocrine and hormones
Source sentences
Summary
A decreasing trend in the serum levels of FSH and estradiol and an increasing trend of menopausal symptoms were recorded during the study.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
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).
Show in the study text Report a problemFND-3795016201
08HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialActivity measurement
In premenopausal women with breast cancer, serum estradiol decreased during the study across the three groups (Diphereline 11.25 mg and two Microrelin regimens).
In plain wordsIn women with breast cancer, estradiol fell during the study across all three treatment groups.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
DecreaseEstradiol trend across formulations
Study
n = 133
Outcome group
Sex hormones and fertility · Endocrine and hormones
Source sentences
Summary
A decreasing trend in the serum levels of FSH and estradiol and an increasing trend of menopausal symptoms were recorded during the study.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
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).
Show in the study text Report a problemFND-3795016202
09HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialSafety outcome
In premenopausal women with breast cancer, menopausal symptoms increased during the study across the three groups (Diphereline 11.25 mg and two Microrelin regimens).
In plain wordsIn women with breast cancer, menopausal symptoms increased during the study across all three treatment groups.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
IncreaseMenopausal symptom trend across formulations
Study
n = 133
Outcome group
Adverse events · Endocrine and hormones
Source sentences
Summary
A decreasing trend in the serum levels of FSH and estradiol and an increasing trend of menopausal symptoms were recorded during the study.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
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).
Show in the study text Report a problemFND-3795016203
10HumanNot a test of Triptorelin (Trelstar, Decapeptyl) aloneRandomized controlled trialSafety outcome
In premenopausal women with breast cancer, no side effects leading to drug disruption, hospitalization, or study exclusion were observed across the three groups (Diphereline 11.25 mg and two Microrelin regimens).
In plain wordsIn women with breast cancer, no side effects caused drug disruption, hospitalization, or study exclusion in any of the three groups.
Peptide
Triptorelin (Trelstar, Decapeptyl)
Outcome
Not applicableTreatment-disrupting side effects
Study
n = 133
Outcome group
Adverse events · Endocrine and hormones
Source sentences
Summary
No specific side effects leading to drug disruption, hospitalization, or exclusion from the study were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy.
Summary · context
The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg).
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).
Show in the study text Report a problemFND-3795016204

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

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