Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part I. Absolute bioavailability of 0.25 mg of ganirelix after a single subcutaneous injection in healthy female volunteers.

Oberyé JJ, Mannaerts BM, Kleijn HJ, Timmer CJ

Fertility and sterility1 Dec 1999Cited by 51 (Europe PMC)

PMID10593371DOI10.1016/s0015-0282(99)00413-6PepBankPUB-10593371

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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 study8

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

01HumanRandomized controlled trialPharmacokinetics
In healthy female volunteers, ganirelix concentration-time profiles were comparable after subcutaneous and intravenous administration.
In plain wordsIn healthy female volunteers, ganirelix concentration-time profiles were comparable after subcutaneous and intravenous administration.
Peptide
Ganirelix
Outcome
Direction not reportedConcentration-time profile
Study
n = 15
Comparator
Intravenous ganirelix
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.25 mg · subcutaneous · Single injectionAs given in this study (human).
Source sentences
Summary
The mean concentration-time profile after SC administration was comparable to that after IV administration.
4 context sentences(design, population, supporting numbers)
Summary · context
Randomized, crossover, pharmacokinetic study.
Summary · context
Nineteen healthy female volunteers of reproductive age.
Summary · context
Two separate injections of 0.25 mg of ganirelix were given, one subcutaneously and one intravenously, with a washout period of 1 week between injections.
Summary · context
Fifteen subjects were evaluated.
Report a problemFND-1059337101
02HumanRandomized controlled trialPharmacokinetics
In healthy female volunteers, ganirelix half-life was similar after intravenous and subcutaneous dosing, at 12.7+/-3.7 and 12.8+/-4.3 hours respectively.
In plain wordsIn healthy female volunteers, ganirelix half-life was similar after intravenous and subcutaneous dosing.
Peptide
Ganirelix
Outcome
Direction not reportedIntravenous half-life
Study
n = 15
Comparator
Subcutaneous ganirelix
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.25 mg · intravenous · Single injectionAs given in this study (human).
Measurements
Half-life, mean
12.7 hours
intravenous administration
Half-life, SD
3.7 hours
intravenous administration
Half-life, mean
12.8 hours
subcutaneous administration
Half-life, SD
4.3 hours
subcutaneous administration
Source sentences
Summary
The mean (+/- SD) half-lives after IV administration and SC administration were highly similar (12.7+/-3.7 hours and 12.8+/-4.3 hours, respectively).
4 context sentences(design, population, supporting numbers)
Summary · context
Randomized, crossover, pharmacokinetic study.
Summary · context
Nineteen healthy female volunteers of reproductive age.
Summary · context
Two separate injections of 0.25 mg of ganirelix were given, one subcutaneously and one intravenously, with a washout period of 1 week between injections.
Summary · context
Fifteen subjects were evaluated.
Report a problemFND-1059337104
03HumanRandomized controlled trialPharmacokinetics
In healthy female volunteers, mean absolute ganirelix bioavailability after subcutaneous dosing was 91.3%+/-6.7%.
In plain wordsIn healthy female volunteers, mean absolute ganirelix bioavailability after subcutaneous dosing was 91.3%+/-6.7%.
Peptide
Ganirelix
Outcome
Not applicableAbsolute bioavailability
Study
n = 15
Comparator
Intravenous ganirelix
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.25 mg · subcutaneous · Single injectionAs given in this study (human).
Measurements
Absolute bioavailability, mean
91.3%
SC versus IV 0.25 mg
Absolute bioavailability, SD
6.7%
SC versus IV 0.25 mg
Source sentences
Summary
Mean (+/- SD) AUC0-infinity (area under the concentration-time curve) values of 105+/-11 ng/mL x hours and 96+/-12 ng/mL x hours were calculated for IV administration and SC administration, respectively, resulting in an absolute mean (+/- SD) bioavailability of 91.3%+/-6.7%.
4 context sentences(design, population, supporting numbers)
Summary · context
Randomized, crossover, pharmacokinetic study.
Summary · context
Nineteen healthy female volunteers of reproductive age.
Summary · context
Two separate injections of 0.25 mg of ganirelix were given, one subcutaneously and one intravenously, with a washout period of 1 week between injections.
Summary · context
Fifteen subjects were evaluated.
Report a problemFND-1059337107
04HumanNon-randomized trialPharmacokinetics
In healthy female volunteers, mean ganirelix peak concentration after subcutaneous dosing was 14.8+/-3.2 ng/mL.
In plain wordsIn healthy female volunteers, mean ganirelix peak concentration after subcutaneous dosing was 14.8+/-3.2 ng/mL.
Peptide
Ganirelix
Outcome
Not applicableSubcutaneous peak concentration
Study
n = 15
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.25 mg · subcutaneous · Single injectionAs given in this study (human).
Measurements
Peak concentration, mean
14.8 ng/mL
subcutaneous administration
Peak concentration, SD
3.2 ng/mL
subcutaneous administration
Source sentences
Summary
The mean (+/- SD) peak concentration and time of occurrence after SC administration were 14.8+/-3.2 ng/mL and 1.1+/-0.3 hours, respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Randomized, crossover, pharmacokinetic study.
Summary · context
Nineteen healthy female volunteers of reproductive age.
Summary · context
Two separate injections of 0.25 mg of ganirelix were given, one subcutaneously and one intravenously, with a washout period of 1 week between injections.
Summary · context
Fifteen subjects were evaluated.
Report a problemFND-1059337102
05HumanNon-randomized trialPharmacokinetics
In healthy female volunteers, mean time to ganirelix peak concentration after subcutaneous dosing was 1.1+/-0.3 hours.
In plain wordsIn healthy female volunteers, mean time to ganirelix peak concentration after subcutaneous dosing was 1.1+/-0.3 hours.
Peptide
Ganirelix
Outcome
Not applicableSubcutaneous time to peak
Study
n = 15
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.25 mg · subcutaneous · Single injectionAs given in this study (human).
Measurements
Time to peak concentration, mean
1.1 hours
subcutaneous administration
Time to peak concentration, SD
0.3 hours
subcutaneous administration
Source sentences
Summary
The mean (+/- SD) peak concentration and time of occurrence after SC administration were 14.8+/-3.2 ng/mL and 1.1+/-0.3 hours, respectively.
4 context sentences(design, population, supporting numbers)
Summary · context
Randomized, crossover, pharmacokinetic study.
Summary · context
Nineteen healthy female volunteers of reproductive age.
Summary · context
Two separate injections of 0.25 mg of ganirelix were given, one subcutaneously and one intravenously, with a washout period of 1 week between injections.
Summary · context
Fifteen subjects were evaluated.
Report a problemFND-1059337103
06HumanNon-randomized trialPharmacokinetics
In healthy female volunteers, mean ganirelix AUC0-infinity after intravenous dosing was 105+/-11 ng/mL x hours.
In plain wordsIn healthy female volunteers, mean ganirelix blood exposure after intravenous dosing was 105+/-11 ng/mL x hours.
Peptide
Ganirelix
Outcome
Not applicableIntravenous AUC
Study
n = 15
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.25 mg · intravenous · Single injectionAs given in this study (human).
Measurements
AUC0-infinity, mean
105 ng/mL x hours
intravenous administration
AUC0-infinity, SD
11 ng/mL x hours
intravenous administration
Source sentences
Summary
Mean (+/- SD) AUC0-infinity (area under the concentration-time curve) values of 105+/-11 ng/mL x hours and 96+/-12 ng/mL x hours were calculated for IV administration and SC administration, respectively, resulting in an absolute mean (+/- SD) bioavailability of 91.3%+/-6.7%.
4 context sentences(design, population, supporting numbers)
Summary · context
Randomized, crossover, pharmacokinetic study.
Summary · context
Nineteen healthy female volunteers of reproductive age.
Summary · context
Two separate injections of 0.25 mg of ganirelix were given, one subcutaneously and one intravenously, with a washout period of 1 week between injections.
Summary · context
Fifteen subjects were evaluated.
Report a problemFND-1059337105
07HumanNon-randomized trialPharmacokinetics
In healthy female volunteers, mean ganirelix AUC0-infinity after subcutaneous dosing was 96+/-12 ng/mL x hours.
In plain wordsIn healthy female volunteers, mean ganirelix blood exposure after subcutaneous dosing was 96+/-12 ng/mL x hours.
Peptide
Ganirelix
Outcome
Not applicableSubcutaneous AUC
Study
n = 15
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.25 mg · subcutaneous · Single injectionAs given in this study (human).
Measurements
AUC0-infinity, mean
96 ng/mL x hours
SC administration, 0.25 mg
AUC0-infinity, SD
12 ng/mL x hours
SC administration, 0.25 mg
Source sentences
Summary
Mean (+/- SD) AUC0-infinity (area under the concentration-time curve) values of 105+/-11 ng/mL x hours and 96+/-12 ng/mL x hours were calculated for IV administration and SC administration, respectively, resulting in an absolute mean (+/- SD) bioavailability of 91.3%+/-6.7%.
4 context sentences(design, population, supporting numbers)
Summary · context
Randomized, crossover, pharmacokinetic study.
Summary · context
Nineteen healthy female volunteers of reproductive age.
Summary · context
Two separate injections of 0.25 mg of ganirelix were given, one subcutaneously and one intravenously, with a washout period of 1 week between injections.
Summary · context
Fifteen subjects were evaluated.
Report a problemFND-1059337106
08HumanNon-randomized trialSafety outcome
In healthy female volunteers, both subcutaneous and intravenous ganirelix treatments were well tolerated.
In plain wordsIn healthy female volunteers, both subcutaneous and intravenous ganirelix treatments were well tolerated.
Peptide
Ganirelix
Outcome
Not applicableTolerability
Study
n = 15
Outcome group
Adverse events · Pharmacology
Studied dose
0.25 mg · subcutaneous and intravenous · Single injectionAs given in this study (human).
Source sentences
Summary
Both treatments were well tolerated.
4 context sentences(design, population, supporting numbers)
Summary · context
Randomized, crossover, pharmacokinetic study.
Summary · context
Nineteen healthy female volunteers of reproductive age.
Summary · context
Two separate injections of 0.25 mg of ganirelix were given, one subcutaneously and one intravenously, with a washout period of 1 week between injections.
Summary · context
Fifteen subjects were evaluated.
Report a problemFND-1059337108

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 page ClinicalTrials.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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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MeSH terms

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