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Study · Randomized controlled trial · n = 55 · 2020

4 results

Ulipristal acetate vs gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Short-term results of a double-blind randomized controlled trial.

de Milliano I, Huirne JAF, Thurkow AL, Radder C, Bongers MY, van Vliet H, van de Lande J, van de Ven PM, Hehenkamp WJK

Acta obstetricia et gynecologica Scandinavica27 Sept 2019Cited by 21 (Europe PMC)

PMID31468503 (opens in a new tab)PMCIDPMC6973004 (opens in a new tab)DOI10.1111/aogs.13713 (opens in a new tab)PepBankPUB-31468503
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Summary

IntroductionLaparoscopic myomectomy can be difficult when fibroids are large and numerous. This may result in extensive intraoperative bleeding and the need for a conversion to a laparotomy. Medical pretreatment prior to surgery might reduce these risks by decreasing fibroid size and vascularization of the fibroid. We compared pretreatment with ulipristal acetate (UPA) vs gonadotropin-releasing hormone agonists (GnRHa) prior to laparoscopic myomectomy on several intra- and postoperative outcomes.Material and methodsWe performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands. Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks. The primary outcome was intraoperative blood loss. Secondary outcomes were reduction of fibroid volume, suturing time, total surgery time and surgical ease.ResultsThirty women received UPA and 25 women leuprolide acetate. Non-inferiority of UPA regarding intraoperative blood loss was not demonstrated. When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348-1025] vs 280 mL[100-500]; P = 0.011) and suturing time of the first fibroid was statistically significantly longer (40 minutes [28-48] vs 22 minutes [14-33]; P = 0.003) compared with GnRHa. Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (-7.2% [-35.5 to 54.1] vs -38.4% [-71.5 to -19.3]; P = 0.001). Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa.ConclusionsNon-inferiority of UPA in terms of intraoperative blood loss could not be established, possibly due to the preliminary termination of the study. Pretreatment with GnRHa was more favorable than UPA in terms of fibroid volume reduction, intraoperative blood loss, hemoglobin drop directly postoperatively, suturing time of the first fibroid and several subjective surgical ease parameters.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In women undergoing laparoscopic myomectomy, leuprolide produced lower median blood loss than ulipristal acetate: 280 versus 525 mL (P = 0.011).

    In plain wordsIn women undergoing myomectomy, blood loss was lower with leuprolide than ulipristal acetate.

    Peptide
    Leuprolide
    Outcome
    DecreaseIntraoperative blood loss
    Study

    n = 55

    Comparator
    Ulipristal acetate
    Analysis
    Primary
    Outcome group
    Surgical outcomes · Reproductive and sexual health
    Studied dose
    Dose not stated · intramuscular · single injection; 12-week pretreatment periodAs given in this study (human).

    Measurements

    Median blood loss
    280 mL
    leuprolide
    Median blood loss
    525 mL
    ulipristal
    P
    0.011
    between groups

    Source sentences

    Summary
    When pretreated with UPA, median intraoperative blood loss was statistically significantly higher (525 mL [348-1025] vs 280 mL[100-500]; P = 0.011)
    3 context sentences
    Summary · context
    We performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands.
    Summary · context
    Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks.
    Summary · context
    Thirty women received UPA and 25 women leuprolide acetate.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In women undergoing myomectomy, leuprolide shortened median first-fibroid suturing time versus ulipristal acetate: 22 versus 40 minutes (P = 0.003).

    In plain wordsIn women undergoing myomectomy, suturing took less time with leuprolide than ulipristal acetate.

    Peptide
    Leuprolide
    Outcome
    DecreaseFirst fibroid suturing time
    Study

    n = 55

    Comparator
    Ulipristal acetate
    Analysis
    Secondary
    Outcome group
    Surgical outcomes · Reproductive and sexual health
    Studied dose
    Dose not stated · intramuscular · single injection; 12-week pretreatment periodAs given in this study (human).

    Measurements

    Median first-fibroid suturing time
    22 minutes
    leuprolide (GnRHa)
    Median first-fibroid suturing time
    40 minutes
    ulipristal acetate
    P
    0.003
    between groups

    Source sentences

    Summary
    and suturing time of the first fibroid was statistically significantly longer (40 minutes [28-48] vs 22 minutes [14-33]; P = 0.003) compared with GnRHa.
    3 context sentences
    Summary · context
    We performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands.
    Summary · context
    Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks.
    Summary · context
    Thirty women received UPA and 25 women leuprolide acetate.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In women undergoing myomectomy, fibroid volume fell more with leuprolide than ulipristal acetate: -38.4% versus -7.2% (P = 0.001).

    In plain wordsIn women undergoing myomectomy, leuprolide reduced fibroid volume more than ulipristal acetate.

    Peptide
    Leuprolide
    Outcome
    DecreasePreoperative fibroid volume change
    Study

    n = 55

    Comparator
    Ulipristal acetate
    Analysis
    Secondary
    Outcome group
    Tumor growth · Reproductive and sexual health
    Studied dose
    Dose not stated · intramuscular · single injection; 12-week pretreatment periodAs given in this study (human).

    Measurements

    Median fibroid volume change
    −38.4%
    leuprolide (GnRHa)
    Median fibroid volume change
    −7.2%
    ulipristal acetate
    P
    0.001
    between groups

    Source sentences

    Summary
    Pretreatment with UPA showed smaller reduction in fibroid volume preoperatively compared with GnRHa (-7.2% [-35.5 to 54.1] vs -38.4% [-71.5 to -19.3]; P = 0.001).
    3 context sentences
    Summary · context
    We performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands.
    Summary · context
    Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks.
    Summary · context
    Thirty women received UPA and 25 women leuprolide acetate.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In women undergoing myomectomy, surgery was judged less difficult after leuprolide than after ulipristal acetate.

    In plain wordsIn women undergoing myomectomy, surgery was easier after leuprolide than after ulipristal acetate.

    Peptide
    Leuprolide
    Outcome
    DecreaseSubjective surgical difficulty
    Study

    n = 55

    Comparator
    Ulipristal acetate
    Analysis
    Secondary
    Outcome group
    Surgical outcomes · Reproductive and sexual health
    Studied dose
    Dose not stated · intramuscular · single injection; 12-week pretreatment periodAs given in this study (human).

    Source sentences

    Summary
    Laparoscopic myomectomies in women pretreated with UPA were subjectively judged more difficult than in women pretreated with GnRHa.
    3 context sentences
    Summary · context
    We performed a non-inferiority double-blind randomized controlled trial in nine hospitals in the Netherlands.
    Summary · context
    Women were randomized between daily oral UPA for 12 weeks and single placebo injection or single intramuscular injection with leuprolide acetate and daily placebo tablets for 12 weeks.
    Summary · context
    Thirty women received UPA and 25 women leuprolide acetate.

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.

  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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