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Study · Randomized controlled trial · n = 183 · 2021

9 results

Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study.

Osuga Y, Seki Y, Tanimoto M, Kusumoto T, Kudou K, Terakawa N

Fertility and sterility7 Sept 2020Cited by 67 (Europe PMC)

PMID32912633 (opens in a new tab)DOI10.1016/j.fertnstert.2020.07.055 (opens in a new tab)PepBankPUB-32912633
Publisher pagePubMedAsk about this study
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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 study9

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In women with endometriosis-associated pain, pain score changed by -10.6 mm with leuprorelin versus -6.2 mm with relugolix 10 mg.

    In plain wordsIn women with endometriosis-associated pain, pain score changed by -10.6 mm with leuprorelin versus -6.2 mm with relugolix 10 mg.

    Peptide
    Leuprolide
    Outcome
    DecreasePelvic pain versus relugolix 10 mg
    Study

    n = 183

    Comparator
    Relugolix 10 mg
    Analysis
    Primary
    Outcome group
    Pain · Reproductive and sexual health
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Measurements

    Mean change in mean VAS pelvic pain score
    −10.6 mm
    leuprorelin
    Mean change in mean VAS pelvic pain score
    −6.2 mm
    relugolix 10 mg

    Source sentences

    Summary
    The mean changes in mean visual analog scale score for pelvic pain were -3.8 mm in the placebo group; -6.2, -8.1, and -10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and -10.6 mm in the leuprorelin group.
    4 context sentences
    Summary · context
    Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment.
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In women with endometriosis-associated pain, pain score changed by -10.6 mm with leuprorelin versus -10.4 mm with relugolix 40 mg.

    In plain wordsIn women with endometriosis-associated pain, pain score changed by -10.6 mm with leuprorelin versus -10.4 mm with relugolix 40 mg.

    Peptide
    Leuprolide
    Outcome
    DecreasePelvic pain versus relugolix 40 mg
    Study

    n = 183

    Comparator
    Relugolix 40 mg
    Analysis
    Primary
    Outcome group
    Pain · Reproductive and sexual health
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Measurements

    Mean change in mean VAS pelvic pain score
    −10.6 mm
    leuprorelin
    Mean change in mean VAS pelvic pain score
    −10.4 mm
    relugolix 40 mg

    Source sentences

    Summary
    The mean changes in mean visual analog scale score for pelvic pain were -3.8 mm in the placebo group; -6.2, -8.1, and -10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and -10.6 mm in the leuprorelin group.
    4 context sentences
    Summary · context
    Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment.
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In women with endometriosis-associated pain, pain score changed by -10.6 mm with leuprorelin versus -8.1 mm with relugolix 20 mg.

    In plain wordsIn women with endometriosis-associated pain, pain score changed by -10.6 mm with leuprorelin versus -8.1 mm with relugolix 20 mg.

    Peptide
    Leuprolide
    Outcome
    DecreasePelvic pain versus relugolix 20 mg
    Study

    n = 180

    Comparator
    Relugolix 20 mg
    Analysis
    Primary
    Outcome group
    Pain · Reproductive and sexual health
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Measurements

    Mean change in mean VAS pelvic pain score
    −10.6 mm
    leuprorelin
    Mean change in mean VAS pelvic pain score
    −8.1 mm
    relugolix 20 mg

    Source sentences

    Summary
    The mean changes in mean visual analog scale score for pelvic pain were -3.8 mm in the placebo group; -6.2, -8.1, and -10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and -10.6 mm in the leuprorelin group.
    4 context sentences
    Summary · context
    Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment.
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In women with endometriosis-associated pain, mean pelvic pain score changed by -10.6 mm with leuprorelin versus -3.8 mm with placebo.

    In plain wordsIn women with endometriosis-associated pain, pain score changed by -10.6 mm with leuprorelin versus -3.8 mm with placebo.

    Peptide
    Leuprolide
    Outcome
    DecreasePelvic pain versus placebo
    Study

    n = 177

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Pain · Reproductive and sexual health
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Measurements

    Mean change in mean VAS pelvic pain score
    −10.6 mm
    leuprorelin
    Mean change in mean VAS pelvic pain score
    −3.8 mm
    placebo

    Source sentences

    Summary
    The mean changes in mean visual analog scale score for pelvic pain were -3.8 mm in the placebo group; -6.2, -8.1, and -10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and -10.6 mm in the leuprorelin group.
    4 context sentences
    Summary · context
    Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment.
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
  5. 05HumanRandomized controlled trialSafety outcome

    In women with endometriosis, hot flush frequency with leuprorelin was comparable with relugolix 40 mg.

    In plain wordsIn women with endometriosis, hot flush frequency with leuprorelin was comparable with relugolix 40 mg.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedHot flush
    Study

    n = 183

    Comparator
    Relugolix 40 mg
    Outcome group
    Adverse events · Reproductive and sexual health
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.
    3 context sentences
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
  6. 06HumanRandomized controlled trialSafety outcome

    In women with endometriosis, metrorrhagia frequency with leuprorelin was comparable with relugolix 40 mg.

    In plain wordsIn women with endometriosis, metrorrhagia frequency with leuprorelin was comparable with relugolix 40 mg.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedMetrorrhagia
    Study

    n = 183

    Comparator
    Relugolix 40 mg
    Outcome group
    Adverse events · Reproductive and sexual health
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.
    3 context sentences
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
  7. 07HumanRandomized controlled trialSafety outcome

    In women with endometriosis, menorrhagia frequency with leuprorelin was comparable with relugolix 40 mg.

    In plain wordsIn women with endometriosis, menorrhagia frequency with leuprorelin was comparable with relugolix 40 mg.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedMenorrhagia
    Study

    n = 183

    Comparator
    Relugolix 40 mg
    Outcome group
    Adverse events · Reproductive and sexual health
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.
    3 context sentences
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
  8. 08HumanRandomized controlled trialSafety outcome

    In women with endometriosis, irregular menstruation frequency with leuprorelin was comparable with relugolix 40 mg.

    In plain wordsIn women with endometriosis, irregular menstruation frequency with leuprorelin was comparable with relugolix 40 mg.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedIrregular menstruation
    Study

    n = 183

    Comparator
    Relugolix 40 mg
    Outcome group
    Adverse events · Reproductive and sexual health
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.
    3 context sentences
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
  9. 09HumanRandomized controlled trialSafety outcome

    In women with endometriosis, bone mineral density decrease frequency with leuprorelin was comparable with relugolix 40 mg.

    In plain wordsIn women with endometriosis, bone mineral density decrease frequency with leuprorelin was comparable with relugolix 40 mg.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedBone mineral density decrease
    Study

    n = 183

    Comparator
    Relugolix 40 mg
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    3.75 mg monthly · subcutaneous injection · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.
    3 context sentences
    Summary · context
    Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
    Summary · context
    Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
    Summary · context
    During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.

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 2NCT01458301

Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

Takedan = 487Oct 2011 to Aug 2013

Endometriosis

Trial pageClinicalTrials.govUpdated 25 Feb 2014

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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