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Study · Randomized controlled trial · n = 265 · 1995

6 results

GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: a randomized controlled trial. Leuprolide Acetate Study Group.

Stovall TG, Muneyyirci-Delale O, Summitt RL Jr, Scialli AR

Obstetrics and gynecology1 Jul 1995Cited by 53 (Europe PMC)

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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with leiomyomas, leuprolide plus iron reduced uterine volume significantly compared with placebo plus iron (P < .01).

    In plain wordsLeuprolide plus iron reduced uterine volume more than placebo plus iron.

    Peptide
    Leuprolide
    Outcome
    DecreaseUterine volume
    Study

    n = 265

    Comparator
    Placebo plus oral iron
    Outcome group
    Tumor growth · Reproductive and sexual health
    Studied dose
    7.5 mg or 3.75 mg · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Gonadotropin-releasing hormone agonist-treated patients had a significant reduction in uterine and myoma volume when compared with the placebo group (P < .01).
    4 context sentences
    Summary · context
    This was a phase III, stratified, randomized, double-blind, placebo-controlled, parallel-group, 12-week multicenter study.
    Summary · context
    Patients within each stratum were randomized to one of three treatment arms: leuprolide acetate depot 7.5 mg, leuprolide acetate depot 3.75 mg, or placebo.
    Summary · context
    All patients received iron orally.
    Summary · context
    Response was defined as a hemoglobin level of 12 g/dL or more and a hematocrit value of 36% or greater.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with leiomyomas, leuprolide plus iron reduced myoma volume significantly compared with placebo plus iron (P < .01).

    In plain wordsLeuprolide plus iron reduced myoma volume more than placebo plus iron.

    Peptide
    Leuprolide
    Outcome
    DecreaseMyoma volume
    Study

    n = 265

    Comparator
    Placebo plus oral iron
    Outcome group
    Tumor growth · Reproductive and sexual health
    Studied dose
    7.5 mg or 3.75 mg · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Gonadotropin-releasing hormone agonist-treated patients had a significant reduction in uterine and myoma volume when compared with the placebo group (P < .01).
    4 context sentences
    Summary · context
    This was a phase III, stratified, randomized, double-blind, placebo-controlled, parallel-group, 12-week multicenter study.
    Summary · context
    Patients within each stratum were randomized to one of three treatment arms: leuprolide acetate depot 7.5 mg, leuprolide acetate depot 3.75 mg, or placebo.
    Summary · context
    All patients received iron orally.
    Summary · context
    Response was defined as a hemoglobin level of 12 g/dL or more and a hematocrit value of 36% or greater.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with leiomyoma-associated anemia, 74% responded to leuprolide 7.5 mg plus iron versus 46% with placebo plus iron (P < .001).

    In plain wordsAnemia response was higher with leuprolide 7.5 mg plus iron than placebo plus iron.

    Peptide
    Leuprolide
    Outcome
    IncreaseAnemia response
    Study

    n: not reported in source

    Comparator
    Placebo plus oral iron
    Outcome group
    Anemia · Reproductive and sexual health
    Studied dose
    7.5 mg · 12 weeksAs given in this study (human).

    Measurements

    Response
    74%
    leuprolide 7.5 mg
    Response
    46%
    placebo

    Source sentences

    Summary
    Using our response criteria, a significantly greater number of patients in both leuprolide acetate groups (combined strata) responded to therapy than did those in the placebo group: 74% in each leuprolide acetate group versus 46% in the placebo group (P < .001).
    4 context sentences
    Summary · context
    This was a phase III, stratified, randomized, double-blind, placebo-controlled, parallel-group, 12-week multicenter study.
    Summary · context
    Patients within each stratum were randomized to one of three treatment arms: leuprolide acetate depot 7.5 mg, leuprolide acetate depot 3.75 mg, or placebo.
    Summary · context
    All patients received iron orally.
    Summary · context
    Response was defined as a hemoglobin level of 12 g/dL or more and a hematocrit value of 36% or greater.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with leiomyoma-associated anemia, 74% responded to leuprolide 3.75 mg plus iron versus 46% with placebo plus iron (P < .001).

    In plain wordsAnemia response was higher with leuprolide 3.75 mg plus iron than placebo plus iron.

    Peptide
    Leuprolide
    Outcome
    IncreaseAnemia response
    Study

    n: not reported in source

    Comparator
    Placebo plus oral iron
    Outcome group
    Anemia · Reproductive and sexual health
    Studied dose
    3.75 mg · 12 weeksAs given in this study (human).

    Measurements

    Response
    74%
    leuprolide 3.75 mg
    Response
    46%
    placebo

    Source sentences

    Summary
    Using our response criteria, a significantly greater number of patients in both leuprolide acetate groups (combined strata) responded to therapy than did those in the placebo group: 74% in each leuprolide acetate group versus 46% in the placebo group (P < .001).
    4 context sentences
    Summary · context
    This was a phase III, stratified, randomized, double-blind, placebo-controlled, parallel-group, 12-week multicenter study.
    Summary · context
    Patients within each stratum were randomized to one of three treatment arms: leuprolide acetate depot 7.5 mg, leuprolide acetate depot 3.75 mg, or placebo.
    Summary · context
    All patients received iron orally.
    Summary · context
    Response was defined as a hemoglobin level of 12 g/dL or more and a hematocrit value of 36% or greater.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with leiomyomas, hot flashes occurred more often with leuprolide plus iron than placebo plus iron (P < .001).

    In plain wordsHot flashes occurred more often with leuprolide plus iron than placebo plus iron.

    Peptide
    Leuprolide
    Outcome
    IncreaseHot flashes
    Study

    n: not reported in source

    Comparator
    Placebo plus oral iron
    Outcome group
    Adverse events · Reproductive and sexual health
    Studied dose
    7.5 mg or 3.75 mg · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Hot flashes and vaginitis were reported significantly more often (P < .001) in the leuprolide acetate-treated groups than in the placebo group.
    4 context sentences
    Summary · context
    This was a phase III, stratified, randomized, double-blind, placebo-controlled, parallel-group, 12-week multicenter study.
    Summary · context
    Patients within each stratum were randomized to one of three treatment arms: leuprolide acetate depot 7.5 mg, leuprolide acetate depot 3.75 mg, or placebo.
    Summary · context
    All patients received iron orally.
    Summary · context
    Response was defined as a hemoglobin level of 12 g/dL or more and a hematocrit value of 36% or greater.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with leiomyomas, vaginitis occurred more often with leuprolide plus iron than placebo plus iron (P < .001).

    In plain wordsVaginitis occurred more often with leuprolide plus iron than placebo plus iron.

    Peptide
    Leuprolide
    Outcome
    IncreaseVaginitis
    Study

    n: not reported in source

    Comparator
    Placebo plus oral iron
    Outcome group
    Adverse events · Reproductive and sexual health
    Studied dose
    7.5 mg or 3.75 mg · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Hot flashes and vaginitis were reported significantly more often (P < .001) in the leuprolide acetate-treated groups than in the placebo group.
    4 context sentences
    Summary · context
    This was a phase III, stratified, randomized, double-blind, placebo-controlled, parallel-group, 12-week multicenter study.
    Summary · context
    Patients within each stratum were randomized to one of three treatment arms: leuprolide acetate depot 7.5 mg, leuprolide acetate depot 3.75 mg, or placebo.
    Summary · context
    All patients received iron orally.
    Summary · context
    Response was defined as a hemoglobin level of 12 g/dL or more and a hematocrit value of 36% or greater.

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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