Treatment of leiomyomata uteri with leuprolide acetate depot: a double-blind, placebo-controlled, multicenter study. The Leuprolide Study Group.

Friedman AJ, Hoffman DI, Comite F, Browneller RW, Miller JD

Obstetrics and gynecology1 May 1991Cited by 112 (Europe PMC)

PMID1901638PepBankPUB-01901638

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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In women with leiomyomata, uterine volume reduction above 25% occurred in 77% with leuprolide versus 9% with placebo.
In plain wordsIn women with fibroids, substantial uterine shrinkage was more common with leuprolide than placebo.
Peptide
Leuprolide
Outcome
IncreaseUterine volume reduction above 25%
Study
n = 128
Comparator
Placebo
Outcome group
Uterine volume · Reproductive and sexual health
Studied dose
3.75 mg every 4 weeks · intramuscular · 24 weeksAs given in this study (human).
Measurements
Patients with >25% volume reduction
77%
leuprolide
Patients with >25% volume reduction
9%
placebo
Source sentences
Summary
Seventy-seven percent of leuprolide-treated patients had a more than 25% reduction in uterine volume, compared with 9% of placebo-treated controls.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to evaluate efficacy and safety parameters in women with leiomyomata uteri treated with the GnRH agonist leuprolide acetate depot, 3.75 mg intramuscularly every 4 weeks for 24 weeks.
Summary · context
One hundred twenty-eight patients were enrolled in a randomized, double-blind, placebo-controlled multicenter study involving 13 investigative centers.
Report a problemFND-0190163803
02HumanNon-randomized trialEfficacy outcome
In women with leiomyomata and menorrhagia, 37 of 38 patients (97%) had symptom resolution at the final visit with leuprolide.
In plain wordsIn women with fibroids and heavy menstrual bleeding, 37 of 38 had bleeding resolution at the final visit with leuprolide.
Peptide
Leuprolide
Outcome
DecreaseMenorrhagia resolution
Study
n = 38
Outcome group
Menstrual bleeding · Reproductive and sexual health
Studied dose
3.75 mg every 4 weeks · intramuscularAs given in this study (human).
Measurements
Menorrhagia resolution
37 patients
38 presenting with menorrhagia
Menorrhagia resolution
97%
final visit
Source sentences
Summary
Of 38 leuprolide-treated patients presenting with menorrhagia, 37 (97%) had resolution of this symptom at the time of the final visit.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to evaluate efficacy and safety parameters in women with leiomyomata uteri treated with the GnRH agonist leuprolide acetate depot, 3.75 mg intramuscularly every 4 weeks for 24 weeks.
Summary · context
One hundred twenty-eight patients were enrolled in a randomized, double-blind, placebo-controlled multicenter study involving 13 investigative centers.
Report a problemFND-0190163806
03HumanNon-randomized trialEfficacy outcome
In women with leiomyomata, mean uterine volume decreased by 36% after 12 weeks of leuprolide.
In plain wordsIn women with fibroids, mean uterine volume decreased after 12 weeks of leuprolide.
Peptide
Leuprolide
Outcome
DecreaseUterine volume at week 12
Study
n: not reported in source
Outcome group
Uterine volume · Reproductive and sexual health
Studied dose
3.75 mg every 4 weeks · intramuscular · 12 weeksAs given in this study (human).
Measurements
Uterine volume decrease
36%
12 weeks
Source sentences
Summary
Mean uterine volume decreased by 36% at 12 weeks and 45% at 24 weeks of leuprolide therapy.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to evaluate efficacy and safety parameters in women with leiomyomata uteri treated with the GnRH agonist leuprolide acetate depot, 3.75 mg intramuscularly every 4 weeks for 24 weeks.
Summary · context
One hundred twenty-eight patients were enrolled in a randomized, double-blind, placebo-controlled multicenter study involving 13 investigative centers.
Report a problemFND-0190163801
04HumanNon-randomized trialEfficacy outcome
In women with leiomyomata, mean uterine volume decreased by 45% after 24 weeks of leuprolide.
In plain wordsIn women with fibroids, mean uterine volume decreased after 24 weeks of leuprolide.
Peptide
Leuprolide
Outcome
DecreaseUterine volume at week 24
Study
n: not reported in source
Outcome group
Uterine volume · Reproductive and sexual health
Studied dose
3.75 mg every 4 weeks · intramuscular · 24 weeksAs given in this study (human).
Measurements
Uterine volume decrease
45%
24 weeks
Source sentences
Summary
Mean uterine volume decreased by 36% at 12 weeks and 45% at 24 weeks of leuprolide therapy.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to evaluate efficacy and safety parameters in women with leiomyomata uteri treated with the GnRH agonist leuprolide acetate depot, 3.75 mg intramuscularly every 4 weeks for 24 weeks.
Summary · context
One hundred twenty-eight patients were enrolled in a randomized, double-blind, placebo-controlled multicenter study involving 13 investigative centers.
Report a problemFND-0190163802
05HumanNon-randomized trialEfficacy outcome
In women with leiomyomata, mean uterine volume returned to pretreatment size 24 weeks after leuprolide cessation.
In plain wordsIn women with fibroids, uterine volume returned to pretreatment size 24 weeks after leuprolide stopped.
Peptide
Leuprolide
Outcome
No significant changeUterine volume after cessation
Study
n: not reported in source
Comparator
Pretreatment uterine volume
Outcome group
Uterine volume · Reproductive and sexual health
Studied dose
3.75 mg every 4 weeks · intramuscular · 24 weeksAs given in this study (human).
Source sentences
Summary
Mean uterine volume returned to pre-treatment size 24 weeks after cessation of leuprolide treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to evaluate efficacy and safety parameters in women with leiomyomata uteri treated with the GnRH agonist leuprolide acetate depot, 3.75 mg intramuscularly every 4 weeks for 24 weeks.
Summary · context
One hundred twenty-eight patients were enrolled in a randomized, double-blind, placebo-controlled multicenter study involving 13 investigative centers.
Report a problemFND-0190163804
06HumanNon-randomized trialEfficacy outcome
In women with leiomyomata, most patients had symptom resolution or improvement after 24 weeks of leuprolide.
In plain wordsIn women with fibroids, most patients had fewer or no fibroid-related symptoms after 24 weeks of leuprolide.
Peptide
Leuprolide
Outcome
DecreaseFibroid-related symptoms
Study
n: not reported in source
Outcome group
Fibroid symptoms · Reproductive and sexual health
Studied dose
3.75 mg every 4 weeks · intramuscular · 24 weeksAs given in this study (human).
Source sentences
Summary
The majority of patients had resolution or improvement of their fibroid-related symptoms after 24 weeks of leuprolide treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to evaluate efficacy and safety parameters in women with leiomyomata uteri treated with the GnRH agonist leuprolide acetate depot, 3.75 mg intramuscularly every 4 weeks for 24 weeks.
Summary · context
One hundred twenty-eight patients were enrolled in a randomized, double-blind, placebo-controlled multicenter study involving 13 investigative centers.
Report a problemFND-0190163805
07HumanNon-randomized trialSafety outcome
In women with leiomyomata, 95% experienced hypoestrogenism-related side effects with leuprolide.
In plain wordsIn women with fibroids, most women had side effects related to low estrogen during leuprolide treatment.
Peptide
Leuprolide
Outcome
Not applicableHypoestrogenism-related side effects
Study
n: not reported in source
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
3.75 mg every 4 weeks · intramuscularAs given in this study (human).
Measurements
Side effects
95%
hypoestrogenism-related
Source sentences
Summary
Although 95% of women treated with leuprolide acetate experienced some side effects related to hypoestrogenism, only five patients (8%) terminated treatment prematurely.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to evaluate efficacy and safety parameters in women with leiomyomata uteri treated with the GnRH agonist leuprolide acetate depot, 3.75 mg intramuscularly every 4 weeks for 24 weeks.
Summary · context
One hundred twenty-eight patients were enrolled in a randomized, double-blind, placebo-controlled multicenter study involving 13 investigative centers.
Report a problemFND-0190163807
08HumanNon-randomized trialSafety outcome
In women with leiomyomata, five patients (8%) terminated leuprolide treatment prematurely.
In plain wordsIn women with fibroids, five patients stopped leuprolide treatment early.
Peptide
Leuprolide
Outcome
Not applicablePremature treatment termination
Study
n: not reported in source
Outcome group
Adverse events · Reproductive and sexual health
Studied dose
3.75 mg every 4 weeks · intramuscularAs given in this study (human).
Measurements
Premature termination
5 patients
leuprolide
Premature termination
8%
leuprolide
Source sentences
Summary
Although 95% of women treated with leuprolide acetate experienced some side effects related to hypoestrogenism, only five patients (8%) terminated treatment prematurely.
2 context sentences(design, population, supporting numbers)
Summary · context
The purpose of this study was to evaluate efficacy and safety parameters in women with leiomyomata uteri treated with the GnRH agonist leuprolide acetate depot, 3.75 mg intramuscularly every 4 weeks for 24 weeks.
Summary · context
One hundred twenty-eight patients were enrolled in a randomized, double-blind, placebo-controlled multicenter study involving 13 investigative centers.
Report a problemFND-0190163808

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

WithdrawnPhase 3NCT02736435

Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound

Thunder Bay Regional Health Research Instituten = 018 Jan 2018 to 18 Jan 2018

Uterine Leiomyoma

Trial page ClinicalTrials.govUpdated 6 Feb 2018

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

Subjects

Terms as the source lists them.

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