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Study · Randomized controlled trial · n = 269 · 2001

5 results

A phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer.

McLeod D, Zinner N, Tomera K, Gleason D, Fotheringham N, Campion M, Garnick MB

Urology1 Nov 2001Cited by 104 (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 study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In men with prostate cancer, testosterone surge occurred in 82% receiving leuprolide versus none receiving abarelix.

    In plain wordsIn men with prostate cancer, testosterone surged in 82% with leuprolide versus none with abarelix.

    Peptide
    Leuprolide
    Outcome
    IncreaseTestosterone surge
    Study

    n = 269

    Comparator
    Abarelix 100 mg
    Analysis
    Primary
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    7.5 mg · intramuscularAs given in this study (human).

    Measurements

    Testosterone surge
    82%
    leuprolide
    P value
    < 0.001
    between groups

    Source sentences

    Summary
    No men in the abarelix group and 82% of men in the leuprolide acetate group experienced a testosterone surge (P <0.001).
    1 context sentence
    Summary · context
    Patients (n = 269) were randomized to receive open-label abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In men with prostate cancer, comparable proportions achieved and maintained castration on days 29-85 with leuprolide and abarelix.

    In plain wordsIn men with prostate cancer, similar proportions achieved and maintained castration on days 29-85 with leuprolide and abarelix.

    Peptide
    Leuprolide
    Outcome
    No significant changeAchievement and maintenance of castration on days 29-85
    Study

    n = 269

    Comparator
    Abarelix 100 mg
    Analysis
    Primary
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    7.5 mg · intramuscularAs given in this study (human).

    Source sentences

    Summary
    A comparable percentage of men achieved and maintained castration between days 29 and 85 in each group.
    1 context sentence
    Summary · context
    Patients (n = 269) were randomized to receive open-label abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In men with prostate cancer, medical castration one day after treatment occurred in 0% with leuprolide versus 24% with abarelix.

    In plain wordsIn men with prostate cancer, medical castration after one day occurred in 0% with leuprolide versus 24% with abarelix.

    Peptide
    Leuprolide
    Outcome
    DecreaseMedical castration one day after treatment
    Study

    n = 269

    Comparator
    Abarelix 100 mg
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    7.5 mg · intramuscularAs given in this study (human).

    Measurements

    Medical castration
    0%
    leuprolide, day 1
    Medical castration
    24%
    abarelix, day 1

    Source sentences

    Summary
    Abarelix caused rapid medical castration: 24% of men 1 day after treatment and 78% after 7 days compared with 0% of men treated with leuprolide acetate on either day.
    1 context sentence
    Summary · context
    Patients (n = 269) were randomized to receive open-label abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In men with prostate cancer, medical castration after seven days occurred in 0% with leuprolide versus 78% with abarelix.

    In plain wordsIn men with prostate cancer, medical castration after seven days occurred in 0% with leuprolide versus 78% with abarelix.

    Peptide
    Leuprolide
    Outcome
    DecreaseMedical castration seven days after treatment
    Study

    n = 269

    Comparator
    Abarelix 100 mg
    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    7.5 mg · intramuscularAs given in this study (human).

    Measurements

    Medical castration
    0%
    leuprolide, day 7
    Medical castration
    78%
    abarelix, day 7

    Source sentences

    Summary
    Abarelix caused rapid medical castration: 24% of men 1 day after treatment and 78% after 7 days compared with 0% of men treated with leuprolide acetate on either day.
    1 context sentence
    Summary · context
    Patients (n = 269) were randomized to receive open-label abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection.
  5. 05HumanRandomized controlled trialSafety outcome

    In men with prostate cancer, overall adverse event occurrence was similar with leuprolide and abarelix.

    In plain wordsIn men with prostate cancer, overall adverse event occurrence was similar with leuprolide and abarelix.

    Peptide
    Leuprolide
    Outcome
    No significant changeOverall adverse event occurrence
    Study

    n = 269

    Comparator
    Abarelix 100 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    7.5 mg · intramuscularAs given in this study (human).

    Source sentences

    Summary
    The overall occurrence of adverse events was similar across the treatment groups, and most were sequelae of comorbid disorders.
    1 context sentence
    Summary · context
    Patients (n = 269) were randomized to receive open-label abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection.

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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