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Study · Randomized controlled trial · n = 15 · 1999

13 results

Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part II. Dose-proportionality and gonadotropin suppression after multiple doses of ganirelix in healthy female volunteers.

Oberyé JJ, Mannaerts BM, Huisman JA, Timmer CJ

Fertility and sterility1 Dec 1999Cited by 80 (Europe PMC)

PMID10593372 (opens in a new tab)DOI10.1016/s0015-0282(99)00414-8 (opens in a new tab)PepBankPUB-10593372
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 study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy female volunteers, ganirelix peak concentrations increased in a dose-proportional manner.

    In plain wordsIn healthy female volunteers, higher ganirelix doses produced proportionally higher peak concentrations than lower doses.

    Peptide
    Ganirelix
    Outcome
    IncreaseDose-proportional peak concentration
    Study

    n: not reported in source

    Comparator
    Lower ganirelix doses
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.125, 0.25, or 0.50 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean peak concentration
    5.2 ng/mL
    0.125 mg once daily
    Mean peak concentration
    11.2 ng/mL
    0.25 mg once daily
    Mean peak concentration
    22.2 ng/mL
    0.50 mg once daily

    Source sentences

    Summary
    Peak concentrations, which occurred approximately 1 hour after dosing, increased in a dose-proportional manner and averaged 5.2 ng/mL, 11.2 ng/mL, and 22.2 ng/mL for the 0.125-mg, 0.25-mg, and 0.50-mg doses, respectively.
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  2. 02HumanNon-randomized trialPharmacokinetics

    In healthy female volunteers, mean ganirelix peak concentration was 5.2 ng/mL with the 0.125-mg dose.

    In plain wordsIn healthy female volunteers, mean ganirelix peak concentration was 5.2 ng/mL with the 0.125-mg dose.

    Peptide
    Ganirelix
    Outcome
    Not applicablePeak concentration at 0.125 mg
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.125 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean peak concentration
    5.2 ng/mL
    0.125 mg once daily, 7 days

    Source sentences

    Summary
    Peak concentrations, which occurred approximately 1 hour after dosing, increased in a dose-proportional manner and averaged 5.2 ng/mL, 11.2 ng/mL, and 22.2 ng/mL for the 0.125-mg, 0.25-mg, and 0.50-mg doses, respectively.
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  3. 03HumanNon-randomized trialPharmacokinetics

    In healthy female volunteers, mean ganirelix peak concentration was 11.2 ng/mL with the 0.25-mg dose.

    In plain wordsIn healthy female volunteers, mean ganirelix peak concentration was 11.2 ng/mL with the 0.25-mg dose.

    Peptide
    Ganirelix
    Outcome
    Not applicablePeak concentration at 0.25 mg
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.25 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean peak concentration
    11.2 ng/mL
    0.25 mg once daily, 7 days

    Source sentences

    Summary
    Peak concentrations, which occurred approximately 1 hour after dosing, increased in a dose-proportional manner and averaged 5.2 ng/mL, 11.2 ng/mL, and 22.2 ng/mL for the 0.125-mg, 0.25-mg, and 0.50-mg doses, respectively.
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  4. 04HumanNon-randomized trialPharmacokinetics

    In healthy female volunteers, mean ganirelix peak concentration was 22.2 ng/mL with the 0.50-mg dose.

    In plain wordsIn healthy female volunteers, mean ganirelix peak concentration was 22.2 ng/mL with the 0.50-mg dose.

    Peptide
    Ganirelix
    Outcome
    Not applicablePeak concentration at 0.50 mg
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.50 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean peak concentration
    22.2 ng/mL
    0.50 mg once daily, 7 days

    Source sentences

    Summary
    Peak concentrations, which occurred approximately 1 hour after dosing, increased in a dose-proportional manner and averaged 5.2 ng/mL, 11.2 ng/mL, and 22.2 ng/mL for the 0.125-mg, 0.25-mg, and 0.50-mg doses, respectively.
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  5. 05HumanNon-randomized trialPharmacokinetics

    In healthy female volunteers, mean ganirelix AUC over 24 hours was 33 ng x h/mL at 0.125 mg.

    In plain wordsIn healthy female volunteers, mean ganirelix blood exposure over 24 hours was 33 ng x h/mL at 0.125 mg.

    Peptide
    Ganirelix
    Outcome
    Not applicableAUC at 0.125 mg
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.125 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean AUC over one dosing interval
    33 ng x h/mL
    0.125 mg once daily, 24 h interval

    Source sentences

    Summary
    Corresponding mean values for the area under the curve over one dosing interval (24 hours) were 33 ng x h/mL, 77.1 ng x h/mL, and 137.8 ng x h/mL, respectively.
    4 context sentences
    Summary · context
    Peak concentrations, which occurred approximately 1 hour after dosing, increased in a dose-proportional manner and averaged 5.2 ng/mL, 11.2 ng/mL, and 22.2 ng/mL for the 0.125-mg, 0.25-mg, and 0.50-mg doses, respectively.
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  6. 06HumanNon-randomized trialPharmacokinetics

    In healthy female volunteers, mean ganirelix AUC over 24 hours was 77.1 ng x h/mL at 0.25 mg.

    In plain wordsIn healthy female volunteers, mean ganirelix blood exposure over 24 hours was 77.1 ng x h/mL at 0.25 mg.

    Peptide
    Ganirelix
    Outcome
    Not applicableAUC at 0.25 mg
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.25 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean AUC over one dosing interval
    77.1 ng x h/mL
    0.25 mg once daily, 24 h interval

    Source sentences

    Summary
    Corresponding mean values for the area under the curve over one dosing interval (24 hours) were 33 ng x h/mL, 77.1 ng x h/mL, and 137.8 ng x h/mL, respectively.
    4 context sentences
    Summary · context
    Peak concentrations, which occurred approximately 1 hour after dosing, increased in a dose-proportional manner and averaged 5.2 ng/mL, 11.2 ng/mL, and 22.2 ng/mL for the 0.125-mg, 0.25-mg, and 0.50-mg doses, respectively.
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  7. 07HumanNon-randomized trialPharmacokinetics

    In healthy female volunteers, mean ganirelix AUC over 24 hours was 137.8 ng x h/mL at 0.50 mg.

    In plain wordsIn healthy female volunteers, mean ganirelix blood exposure over 24 hours was 137.8 ng x h/mL at 0.50 mg.

    Peptide
    Ganirelix
    Outcome
    Not applicableAUC at 0.50 mg
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.50 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean AUC over one dosing interval
    137.8 ng x h/mL
    0.50 mg once daily, 24 h interval

    Source sentences

    Summary
    Corresponding mean values for the area under the curve over one dosing interval (24 hours) were 33 ng x h/mL, 77.1 ng x h/mL, and 137.8 ng x h/mL, respectively.
    4 context sentences
    Summary · context
    Peak concentrations, which occurred approximately 1 hour after dosing, increased in a dose-proportional manner and averaged 5.2 ng/mL, 11.2 ng/mL, and 22.2 ng/mL for the 0.125-mg, 0.25-mg, and 0.50-mg doses, respectively.
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  8. 08HumanNon-randomized trialActivity measurement

    In healthy female volunteers, LH decreased maximally by 74% at 4 hours after the last 0.25-mg ganirelix dose.

    In plain wordsIn healthy female volunteers, LH decreased maximally by 74% at 4 hours after the last 0.25-mg ganirelix dose.

    Peptide
    Ganirelix
    Outcome
    DecreaseLH suppression
    Study

    n = 15

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    0.25 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Maximal LH decrease
    74%
    4 hours after last 0.25 mg dose

    Source sentences

    Summary
    After the last 0.25-mg dose of ganirelix, serum LH, FSH, and E2 concentrations were maximally decreased (by 74%, 32%, and 25% at 4 hours, 16 hours, and 16 hours after injection, respectively).
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  9. 09HumanNon-randomized trialActivity measurement

    In healthy female volunteers, FSH decreased maximally by 32% at 16 hours after the last 0.25-mg ganirelix dose.

    In plain wordsIn healthy female volunteers, FSH decreased maximally by 32% at 16 hours after the last 0.25-mg ganirelix dose.

    Peptide
    Ganirelix
    Outcome
    DecreaseFSH suppression
    Study

    n = 15

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    0.25 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Maximal FSH decrease
    32%
    16 hours after last 0.25 mg dose

    Source sentences

    Summary
    After the last 0.25-mg dose of ganirelix, serum LH, FSH, and E2 concentrations were maximally decreased (by 74%, 32%, and 25% at 4 hours, 16 hours, and 16 hours after injection, respectively).
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  10. 10HumanNon-randomized trialActivity measurement

    In healthy female volunteers, E2 decreased maximally by 25% at 16 hours after the last 0.25-mg ganirelix dose.

    In plain wordsIn healthy female volunteers, E2 decreased maximally by 25% at 16 hours after the last 0.25-mg ganirelix dose.

    Peptide
    Ganirelix
    Outcome
    DecreaseE2 suppression
    Study

    n = 15

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    0.25 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Maximal E2 decrease
    25%
    16 hours after last 0.25 mg dose

    Source sentences

    Summary
    After the last 0.25-mg dose of ganirelix, serum LH, FSH, and E2 concentrations were maximally decreased (by 74%, 32%, and 25% at 4 hours, 16 hours, and 16 hours after injection, respectively).
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  11. 11HumanNon-randomized trialPharmacokinetics

    In healthy female volunteers receiving ganirelix, steady-state levels occurred between days 2 and 3.

    In plain wordsIn healthy female volunteers receiving ganirelix, steady-state levels occurred between days 2 and 3.

    Peptide
    Ganirelix
    Outcome
    Not applicableTime to steady state
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.125, 0.25, or 0.50 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Time to steady state
    2 to 3 days
    once-daily SC ganirelix

    Source sentences

    Summary
    Steady-state levels were reached between days 2 and 3.
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  12. 12HumanNon-randomized trialPharmacokinetics

    In healthy female volunteers receiving ganirelix, peak concentrations occurred approximately 1 hour after dosing.

    In plain wordsIn healthy female volunteers receiving ganirelix, peak concentrations occurred approximately 1 hour after dosing.

    Peptide
    Ganirelix
    Outcome
    Not applicableTime to peak concentration
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.125, 0.25, or 0.50 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Time to peak concentration
    ≈ 1 hour
    after dosing, once-daily SC ganirelix

    Source sentences

    Summary
    Peak concentrations, which occurred approximately 1 hour after dosing, increased in a dose-proportional manner and averaged 5.2 ng/mL, 11.2 ng/mL, and 22.2 ng/mL for the 0.125-mg, 0.25-mg, and 0.50-mg doses, respectively.
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.
  13. 13HumanNon-randomized trialActivity measurement

    In healthy female volunteers, serum hormone levels returned to pretreatment values within 2 days after the last ganirelix injection.

    In plain wordsIn healthy female volunteers, serum hormone levels returned to pretreatment values within 2 days after the last ganirelix injection.

    Peptide
    Ganirelix
    Outcome
    Not applicableHormone recovery
    Study

    n: not reported in source

    Outcome group
    Sex hormones and fertility · Endocrine and hormones
    Studied dose
    0.125, 0.25, or 0.50 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Time to return to pretreatment hormone levels
    ≤ 2 days
    after last injection

    Source sentences

    Summary
    Serum hormone levels returned to pretreatment values within 2 days after the last injection.
    3 context sentences
    Summary · context
    Randomized, parallel, pharmacokinetic, and pharmacodynamic study.
    Summary · context
    Three groups of 15 healthy female volunteers of reproductive age.
    Summary · context
    Subcutaneous injections of 0.125 mg, 0.25 mg, or 0.50 mg of ganirelix were given once daily for 7 days.

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

CompletedNot applicableNCT03236545

Menopause Effects on Vascular Function

University of Delawaren = 481 Jul 2016 to 1 Nov 2022

Cardiovascular Risk Factor

Trial pageClinicalTrials.govUpdated 14 Nov 2022

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, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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