Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study.

Harada T, Osuga Y, Suzuki Y, Fujisawa M, Fukui M, Kitawaki J

Fertility and sterility8 Dec 2021Cited by 47 (Europe PMC)

PMID34895700DOI10.1016/j.fertnstert.2021.11.013PepBankPUB-34895700

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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In women with endometriosis-associated pain, maximum pelvic pain score changed by -57.5 ± 1.4 with leuprorelin versus -52.6 ± 1.3 with relugolix.
In plain wordsIn women with endometriosis-associated pain, pelvic pain score changed by -57.5 with leuprorelin versus -52.6 with relugolix.
Peptide
Leuprolide
Outcome
DecreasePelvic pain score
Study
n: not reported in source
Comparator
Relugolix 40 mg
Analysis
Primary
Outcome group
Pain · Reproductive and sexual health
Studied dose
3.75 or 1.88 mg every 4 weeks · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Change in maximum VAS pelvic pain score
−57.5 score
leuprorelin
Variation
1.4 score
leuprorelin
Change in maximum VAS pelvic pain score
−52.6 score
relugolix 40 mg
Variation
1.3 score
relugolix 40 mg
Source sentences
Summary
Changes in the maximum visual analog scale score were -52.6 ± 1.3 for REL and -57.5 ± 1.4 for LEU.
4 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the change in the maximum visual analog scale score for pelvic pain from baseline until 28 days before the end of treatment.
Summary · context
Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.
Summary · context
Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.
Summary · context
In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.
Report a problemFND-3489570001
02HumanRandomized controlled trialEfficacy outcome
In women with endometriosis, ovarian endometrioma decreased by 14.10 ± 18.81 cm³ with leuprorelin versus 12.26 ± 17.52 cm³ with relugolix.
In plain wordsIn women with endometriosis, ovarian endometrioma volume decreased by 14.10 cm³ with leuprorelin versus 12.26 cm³ with relugolix.
Peptide
Leuprolide
Outcome
DecreaseOvarian endometrioma volume
Study
n: not reported in source
Comparator
Relugolix 40 mg
Outcome group
Endometriosis lesions · Reproductive and sexual health
Studied dose
3.75 or 1.88 mg every 4 weeks · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Volume decrease
14.1 cm³
leuprorelin
Variation
18.81 cm³
leuprorelin
Volume decrease
12.26 cm³
relugolix
Variation
17.52 cm³
relugolix
Source sentences
Summary
Ovarian endometrioma decreased by 12.26 ± 17.52 cm³ for REL and 14.10 ± 18.81 cm³ for LEU.
3 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.
Summary · context
Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.
Summary · context
In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.
Report a problemFND-3489570002
03HumanRandomized controlled trialSafety outcome
In women with endometriosis, 4.3% discontinued leuprorelin because of treatment-emergent adverse events, compared with 2.9% receiving relugolix.
In plain wordsIn women with endometriosis, adverse events led to discontinuation in 4.3% receiving leuprorelin versus 2.9% receiving relugolix.
Peptide
Leuprolide
Outcome
IncreaseDiscontinuation due to adverse events
Study
n: not reported in source
Comparator
Relugolix
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
3.75 or 1.88 mg every 4 weeks · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Discontinuation from TEAEs
4.3%
leuprorelin
Discontinuation from TEAEs
2.9%
relugolix
Source sentences
Summary
Discontinuations from treatment emergent adverse events were 2.9% for REL and 4.3% for LEU.
3 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.
Summary · context
Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.
Summary · context
In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.
Report a problemFND-3489570007
04HumanNon-randomized trialSafety outcome
In women with endometriosis, drug-related hot flush occurred in more than 10% receiving leuprorelin.
In plain wordsIn women with endometriosis, drug-related hot flush occurred in more than 10% receiving leuprorelin.
Peptide
Leuprolide
Outcome
Not applicableHot flush
Study
n: not reported in source
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
3.75 or 1.88 mg every 4 weeks · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Incidence of drug-related TEAE (hot flush)
> 10%
leuprorelin group
Source sentences
Summary
Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage.
3 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.
Summary · context
Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.
Summary · context
In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.
Report a problemFND-3489570003
05HumanNon-randomized trialSafety outcome
In women with endometriosis, drug-related metrorrhagia occurred in more than 10% receiving leuprorelin.
In plain wordsIn women with endometriosis, drug-related metrorrhagia occurred in more than 10% receiving leuprorelin.
Peptide
Leuprolide
Outcome
Not applicableMetrorrhagia
Study
n: not reported in source
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
3.75 or 1.88 mg every 4 weeks · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Incidence of drug-related TEAE (metrorrhagia)
> 10%
leuprorelin group
Source sentences
Summary
Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage.
3 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.
Summary · context
Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.
Summary · context
In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.
Report a problemFND-3489570004
06HumanNon-randomized trialSafety outcome
In women with endometriosis, drug-related headache occurred in more than 10% receiving leuprorelin.
In plain wordsIn women with endometriosis, drug-related headache occurred in more than 10% receiving leuprorelin.
Peptide
Leuprolide
Outcome
Not applicableHeadache
Study
n: not reported in source
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
3.75 or 1.88 mg every 4 weeks · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Incidence of drug-related TEAE (headache)
> 10%
leuprorelin group
Source sentences
Summary
Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage.
3 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.
Summary · context
Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.
Summary · context
In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.
Report a problemFND-3489570005
07HumanNon-randomized trialSafety outcome
In women with endometriosis, drug-related genital hemorrhage occurred in more than 10% receiving leuprorelin.
In plain wordsIn women with endometriosis, drug-related genital hemorrhage occurred in more than 10% receiving leuprorelin.
Peptide
Leuprolide
Outcome
Not applicableGenital hemorrhage
Study
n: not reported in source
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
3.75 or 1.88 mg every 4 weeks · subcutaneous · 24 weeksAs given in this study (human).
Measurements
Incidence of drug-related TEAE (genital hemorrhage)
> 10%
leuprorelin group
Source sentences
Summary
Drug-related treatment emergent adverse events with an incidence of >10% for both groups were hot flush, metrorrhagia, headache, and genital hemorrhage.
3 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study in Japanese patients.
Summary · context
Women aged ≥20 years with regular menstrual cycles (25-38 days) experiencing endometriosis or ovarian endometrioma and reporting pelvic pain.
Summary · context
In the LEU group, 3.75 or 1.88 mg of LEU was subcutaneously injected every 4 weeks for 24 weeks.
Report a problemFND-3489570006

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT03931915

Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis

ASKA Pharmaceutical Co., Ltd.n = 3358 May 2019 to 28 Sept 2020

Endometriosis

Trial page ClinicalTrials.govUpdated 11 Dec 2020

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, 16:37 UTC
First added · source update from Europe PMC

PepBank is a research reference. Talk to a doctor before you use any peptide.

Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study.

Summary

Results from this study7

Registered trials1

Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis

Version history

Subjects

Publication types

MeSH terms

Keywords