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Study · Randomized controlled trial · n = 50 · 1999

6 results

Endocrinological and clinical evaluation of two depot formulations of leuprolide acetate in pre- and perimenopausal breast cancer patients.

Boccardo F, Rubagotti A, Amoroso D, Agostara B, Amadori D, Gallo L, Iacobelli S, Massidda B, Mesiti M, Pacini P, Tomao S, Paganuzzi M, Marroni P

Cancer chemotherapy and pharmacology1 Jan 1999Cited by 21 (Europe PMC)

PMID10321505 (opens in a new tab)DOI10.1007/s002800050924 (opens in a new tab)PepBankPUB-10321505
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: 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 breast cancer patients, median treatment time was comparable between monthly and three-monthly leuprolide formulations.

    In plain wordsIn breast cancer patients, treatment time was comparable between monthly and three-monthly leuprolide.

    Peptide
    Leuprolide
    Outcome
    No significant changeTime on treatment
    Study

    n = 50

    Comparator
    Leuprolide 3.75 mg monthly versus 11.25 mg every 3 months
    Outcome group
    Healthcare costs and utilization · Endocrine and hormones
    Studied dose
    3.75 mg every month or 11.25 mg every 3 months · until disease recurrence or progression, or a maximum of 24 monthsAs given in this study (human).

    Source sentences

    Summary
    The median time on treatment was comparable.
    2 context sentences
    Summary · context
    A total of 50 pre- or perimenopausal patients with early- or late-stage breast cancer who were candidates for endocrine treatment were included in the study
    Summary · context
    In all, 23 patients were allocated to the monthly formulation and 27, to the 3-monthly formulation.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In breast cancer patients, clinical outcomes did not differ between monthly and three-monthly leuprolide formulations.

    In plain wordsIn breast cancer patients, clinical outcomes did not differ between monthly and three-monthly leuprolide.

    Peptide
    Leuprolide
    Outcome
    No significant changeClinical outcome
    Study

    n = 50

    Comparator
    Leuprolide 3.75 mg monthly versus 11.25 mg every 3 months
    Outcome group
    Tumor growth · Cancer
    Studied dose
    3.75 mg every month or 11.25 mg every 3 months · until disease recurrence or progression, or a maximum of 24 monthsAs given in this study (human).

    Source sentences

    Summary
    There was no evidence of any difference in clinical outcome or drug-induced side effects, hot flushes being recorded in about 50% of patients in both groups.
    2 context sentences
    Summary · context
    A total of 50 pre- or perimenopausal patients with early- or late-stage breast cancer who were candidates for endocrine treatment were included in the study
    Summary · context
    In all, 23 patients were allocated to the monthly formulation and 27, to the 3-monthly formulation.
  3. 03HumanRandomized controlled trialSafety outcome

    In breast cancer patients, drug-induced side effects did not differ between monthly and three-monthly leuprolide formulations.

    In plain wordsIn breast cancer patients, side effects did not differ between monthly and three-monthly leuprolide.

    Peptide
    Leuprolide
    Outcome
    No significant changeDrug-induced side effects
    Study

    n = 50

    Comparator
    Leuprolide 3.75 mg monthly versus 11.25 mg every 3 months
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    3.75 mg every month or 11.25 mg every 3 months · until disease recurrence or progression, or a maximum of 24 monthsAs given in this study (human).

    Source sentences

    Summary
    There was no evidence of any difference in clinical outcome or drug-induced side effects, hot flushes being recorded in about 50% of patients in both groups.
    2 context sentences
    Summary · context
    A total of 50 pre- or perimenopausal patients with early- or late-stage breast cancer who were candidates for endocrine treatment were included in the study
    Summary · context
    In all, 23 patients were allocated to the monthly formulation and 27, to the 3-monthly formulation.
  4. 04HumanRandomized controlled trialSafety outcome

    In breast cancer patients, hot flushes occurred in about 50% with each leuprolide formulation, without a reported difference.

    In plain wordsIn breast cancer patients, about 50% reported hot flushes with either leuprolide formulation.

    Peptide
    Leuprolide
    Outcome
    No significant changeHot flushes
    Study

    n = 50

    Comparator
    Leuprolide 3.75 mg monthly versus 11.25 mg every 3 months
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    3.75 mg every month or 11.25 mg every 3 months · until disease recurrence or progression, or a maximum of 24 monthsAs given in this study (human).

    Measurements

    Hot flush incidence
    ≈ 50%
    both groups

    Source sentences

    Summary
    There was no evidence of any difference in clinical outcome or drug-induced side effects, hot flushes being recorded in about 50% of patients in both groups.
    2 context sentences
    Summary · context
    A total of 50 pre- or perimenopausal patients with early- or late-stage breast cancer who were candidates for endocrine treatment were included in the study
    Summary · context
    In all, 23 patients were allocated to the monthly formulation and 27, to the 3-monthly formulation.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In breast cancer patients, endocrine parameters were suppressed similarly with monthly and three-monthly leuprolide formulations.

    In plain wordsIn breast cancer patients, monthly and three-monthly leuprolide suppressed endocrine parameters similarly.

    Peptide
    Leuprolide
    Outcome
    Direction not reportedEndocrine parameter suppression
    Study

    n = 50

    Comparator
    Leuprolide 3.75 mg monthly versus 11.25 mg every 3 months
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    3.75 mg every month or 11.25 mg every 3 monthsAs given in this study (human).

    Source sentences

    Summary
    All endocrine parameters, particularly estradiol levels, were suppressed to a similar extent.
    2 context sentences
    Summary · context
    A total of 50 pre- or perimenopausal patients with early- or late-stage breast cancer who were candidates for endocrine treatment were included in the study
    Summary · context
    In all, 23 patients were allocated to the monthly formulation and 27, to the 3-monthly formulation.
  6. 06HumanNon-randomized trialEfficacy outcome

    In breast cancer patients menstruating before leuprolide, all 35 became amenorrhoic after 3 months and remained so during continued treatment.

    In plain wordsAll 35 breast cancer patients who menstruated before leuprolide stopped menstruating after 3 months and during continued treatment.

    Peptide
    Leuprolide
    Outcome
    IncreaseAmenorrhea
    Study

    n = 35

    Comparator
    Pretreatment menstruation
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    3.75 mg every month or 11.25 mg every 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Altogether, 35 patients were actively menstruating at the beginning of treatment; all of them became amenorrhoic after 3 months and remained so until treatment with leuprolide was continued, irrespective of the allocated treatment.
    2 context sentences
    Summary · context
    A total of 50 pre- or perimenopausal patients with early- or late-stage breast cancer who were candidates for endocrine treatment were included in the study
    Summary · context
    In all, 23 patients were allocated to the monthly formulation and 27, to the 3-monthly formulation.

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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