Oral Gonadotropin-Releasing Hormone Antagonist Relugolix Compared With Leuprorelin Injections for Uterine Leiomyomas: A Randomized Controlled Trial.

Osuga Y, Enya K, Kudou K, Tanimoto M, Hoshiai H

Obstetrics and gynecology1 Mar 2019Cited by 70 (Europe PMC)

PMID30741797DOI10.1097/aog.0000000000003141PepBankPUB-30741797

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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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In women with uterine leiomyomas, PBAC below 10 at weeks 6-12 occurred in 83.1% with leuprorelin versus 82.2% with relugolix (relugolix-leuprorelin difference -0.9%, 95% CI -10.10 to 8.35); noninferiority of relugolix was shown.
In plain wordsIn women with fibroids, relugolix met noninferiority criteria versus leuprorelin for bleeding control at weeks 6-12.
Peptide
Leuprolide
Outcome
IncreasePBAC score below 10 at weeks 6-12
Study
n = 281
Comparator
Relugolix 40 mg daily
Analysis
Primary
Outcome group
Menstrual Bleeding · Reproductive and sexual health
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Measurements
PBAC <10 at weeks 6-12
83.1%
leuprorelin
PBAC <10 at weeks 6-12
82.2%
relugolix
Relugolix-leuprorelin difference
−0.9%
between groups
95% CI range
−10.1 to 8.35%
difference
Noninferiority margin
−15%
prespecified
P
0.001
noninferiority test
Source sentences
Summary
The proportion of patients with total pictorial blood loss assessment chart score of less than 10 for weeks 6-12 was 82.2% in the relugolix group and 83.1% in the leuprorelin group, demonstrating noninferiority of relugolix compared with leuprorelin (relugolix-leuprorelin difference -0.9%; 95% CI: -…
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179701
02HumanRandomized controlled trialEfficacy outcome
In women with uterine leiomyomas, myoma volume reductions were comparable with leuprorelin and relugolix.
In plain wordsIn women with fibroids, leuprorelin and relugolix reduced fibroid volume similarly.
Peptide
Leuprolide
Outcome
Direction not reportedMyoma volume reduction
Study
n = 281
Comparator
Relugolix 40 mg daily
Analysis
Secondary
Outcome group
Tumor growth · Reproductive and sexual health
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Source sentences
Summary
Reductions in myoma and uterine volumes and increases in hemoglobin levels were comparable in the two groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179702
03HumanRandomized controlled trialEfficacy outcome
In women with uterine leiomyomas, uterine volume reductions were comparable with leuprorelin and relugolix.
In plain wordsIn women with fibroids, leuprorelin and relugolix reduced uterine volume similarly.
Peptide
Leuprolide
Outcome
Direction not reportedUterine volume reduction
Study
n = 281
Comparator
Relugolix 40 mg daily
Analysis
Secondary
Outcome group
Tumor growth · Reproductive and sexual health
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Source sentences
Summary
Reductions in myoma and uterine volumes and increases in hemoglobin levels were comparable in the two groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179703
04HumanRandomized controlled trialEfficacy outcome
In women with uterine leiomyomas, hemoglobin increases were comparable with leuprorelin and relugolix.
In plain wordsIn women with fibroids, leuprorelin and relugolix increased hemoglobin similarly.
Peptide
Leuprolide
Outcome
Direction not reportedHemoglobin increase
Study
n = 281
Comparator
Relugolix 40 mg daily
Analysis
Secondary
Outcome group
Blood Counts · Whole body
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Source sentences
Summary
Reductions in myoma and uterine volumes and increases in hemoglobin levels were comparable in the two groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179704
05HumanRandomized controlled trialEfficacy outcome
In women with uterine leiomyomas, early bleeding control occurred in 31.7% with leuprorelin versus 64.2% with relugolix.
In plain wordsIn women with fibroids, early bleeding control was less frequent with leuprorelin than relugolix.
Peptide
Leuprolide
Outcome
DecreasePBAC score below 10 at weeks 2-6
Study
n = 281
Comparator
Relugolix 40 mg daily
Outcome group
Menstrual Bleeding · Reproductive and sexual health
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Measurements
PBAC <10 at weeks 2-6
31.7%
leuprorelin
PBAC <10 at weeks 2-6
64.2%
relugolix
Relugolix-leuprorelin difference
32.5%
between groups
95% CI range
20.95 to 44.13%
difference
Source sentences
Summary
Relugolix was associated with an earlier effect on menstrual bleeding than leuprorelin (pictorial blood loss assessment chart score of less than 10, 64.2% vs 31.7% [relugolix-leuprorelin difference 32.5%; 95% CI: 20.95-44.13%] for weeks 2-6
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179705
06HumanRandomized controlled trialEfficacy outcome
In women with uterine leiomyomas, a zero bleeding score occurred in 21.8% with leuprorelin versus 52.6% with relugolix during weeks 2-6.
In plain wordsIn women with fibroids, absence of early menstrual bleeding was less frequent with leuprorelin than relugolix.
Peptide
Leuprolide
Outcome
DecreasePBAC score zero at weeks 2-6
Study
n = 281
Comparator
Relugolix 40 mg daily
Outcome group
Menstrual Bleeding · Reproductive and sexual health
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Measurements
PBAC score 0 at weeks 2-6
21.8%
leuprorelin
PBAC score 0 at weeks 2-6
52.6%
relugolix
Relugolix-leuprorelin difference
30.7%
between groups
95% CI range
19.45 to 42%
difference
Source sentences
Summary
and pictorial blood loss assessment chart score of 0, 52.6% vs 21.8% [30.7%; 95% CI: 19.45-42.00%] for weeks 2-6)
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179706
07HumanRandomized controlled trialEfficacy outcome
In women with uterine leiomyomas, median menses recovery took 65 days after leuprorelin versus 37 days after relugolix discontinuation.
In plain wordsIn women with fibroids, periods returned later after leuprorelin than relugolix treatment.
Peptide
Leuprolide
Outcome
IncreaseTime to menses recovery
Study
n = 281
Comparator
Relugolix 40 mg daily
Outcome group
Menstrual Bleeding · Reproductive and sexual health
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Measurements
Median time to menses recovery
65 days
leuprorelin
Q1-Q3
54 to 77 days
leuprorelin
Median time to menses recovery
37 days
relugolix
Q1-Q3
32 to 46 days
relugolix
Source sentences
Summary
and faster recovery of menses after treatment discontinuation (relugolix median [Q1, Q3], 37 days [32.0, 46.0]; leuprorelin median, 65 days [54.0, 77.0]).
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179707
08HumanRandomized controlled trialSafety outcome
In women with uterine leiomyomas, adverse events were similar with leuprorelin and relugolix.
In plain wordsIn women with fibroids, adverse events were similar with leuprorelin and relugolix.
Peptide
Leuprolide
Outcome
Direction not reportedAdverse events
Study
n = 281
Comparator
Relugolix 40 mg daily
Outcome group
Adverse events · Whole body
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Source sentences
Summary
Adverse events and bone mineral density loss were similar between relugolix and leuprorelin treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179708
09HumanRandomized controlled trialSafety outcome
In women with uterine leiomyomas, bone mineral density loss was similar with leuprorelin and relugolix.
In plain wordsIn women with fibroids, bone density loss was similar with leuprorelin and relugolix.
Peptide
Leuprolide
Outcome
Direction not reportedBone mineral density loss
Study
n = 281
Comparator
Relugolix 40 mg daily
Outcome group
Bone and joint · Musculoskeletal
Studied dose
1.88 mg or 3.75 mg monthly · injection · 24 weeksAs given in this study (human).
Source sentences
Summary
Adverse events and bone mineral density loss were similar between relugolix and leuprorelin treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In a double-blind, double-dummy trial, premenopausal women with uterine leiomyomas and heavy menstrual bleeding defined as a pictorial blood loss assessment chart score of at least 120 were randomized in a 1:1 ratio
Summary · context
to relugolix (40 mg, oral, once daily) or leuprorelin acetate (1.88 mg or 3.75 mg, monthly injection) for 24 weeks.
Report a problemFND-3074179709

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02655237

A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

Takedan = 2815 Mar 2016 to 25 Sept 2017

Uterine Fibroids

Trial page ClinicalTrials.govUpdated 22 Mar 2019

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

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