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Study · Randomized controlled trial · n = 16 · 2000

10 results

Local tolerance, pharmacokinetics, and dynamics of ganirelix (Orgalutran) administration by Medi-Jector compared to conventional needle injections.

Oberyé J, Mannaerts B, Huisman J, Timmer C

Human reproduction (Oxford, England)1 Feb 2000Cited by 12 (Europe PMC)

PMID10655292 (opens in a new tab)DOI10.1093/humrep/15.2.245 (opens in a new tab)PepBankPUB-10655292
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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 study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy females, ganirelix local tolerance showed no apparent differences between Medi-Jector and conventional needle administration.

    In plain wordsIn healthy females, ganirelix local tolerance showed no apparent differences between Medi-Jector and conventional needles.

    Peptide
    Ganirelix
    Outcome
    Direction not reportedLocal tolerance
    Study

    n = 16

    Comparator
    Conventional needle injection
    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    2 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    No apparent differences in local tolerance were observed.
    3 context sentences
    Summary · context
    Local tolerance and pharmacokinetics of ganirelix administered by MediJector versus conventional needle injections were compared.
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy females, ganirelix Medi-Jector administration was bioequivalent to conventional needle injection for peak concentration.

    In plain wordsIn healthy females, ganirelix peak concentration was bioequivalent with Medi-Jector and conventional needle administration.

    Peptide
    Ganirelix
    Outcome
    No significant changePeak concentration bioequivalence
    Study

    n = 16

    Comparator
    Conventional needle injection
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Administration by Medi-Jector was bioequivalent to conventional needle injection with respect to the peak concentration and area under the curve.
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy females, ganirelix Medi-Jector administration was bioequivalent to conventional needle injection for area under the curve.

    In plain wordsIn healthy females, ganirelix blood exposure was bioequivalent with Medi-Jector and conventional needle administration.

    Peptide
    Ganirelix
    Outcome
    No significant changeAUC bioequivalence
    Study

    n = 16

    Comparator
    Conventional needle injection
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    2 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Administration by Medi-Jector was bioequivalent to conventional needle injection with respect to the peak concentration and area under the curve.
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  4. 04HumanNon-randomized trialSafety outcome

    In healthy females receiving ganirelix, 87.5% of injections caused no reaction or only a mild reaction.

    In plain wordsIn healthy females receiving ganirelix, 87.5% of injections caused no reaction or only a mild reaction.

    Peptide
    Ganirelix
    Outcome
    Not applicableNo or mild injection reactions
    Study

    n = 16

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    2 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Injections with no or mild reaction
    87.5%
    per injection, both delivery methods

    Source sentences

    Summary
    Most injections (87.5%) gave either no or only a mild reaction.
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  5. 05HumanNon-randomized trialSafety outcome

    In healthy females receiving ganirelix, moderate swelling occurred after 4.9% of injections overall.

    In plain wordsIn healthy females receiving ganirelix, moderate swelling occurred after 4.9% of injections.

    Peptide
    Ganirelix
    Outcome
    Not applicableModerate swelling
    Study

    n = 16

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    2 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Moderate swelling
    4.9%
    per injection, overall

    Source sentences

    Summary
    Of the moderate reactions, swelling and redness were reported most frequently (overall 4.9 and 8.5% per injection, respectively).
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  6. 06HumanNon-randomized trialSafety outcome

    In healthy females receiving ganirelix, moderate redness occurred after 8.5% of injections overall.

    In plain wordsIn healthy females receiving ganirelix, moderate redness occurred after 8.5% of injections.

    Peptide
    Ganirelix
    Outcome
    Not applicableModerate redness
    Study

    n = 16

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    2 mg once daily · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Moderate redness
    8.5%
    per injection, overall

    Source sentences

    Summary
    Of the moderate reactions, swelling and redness were reported most frequently (overall 4.9 and 8.5% per injection, respectively).
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  7. 07HumanNon-randomized trialActivity measurement

    In healthy females receiving ganirelix, luteinizing hormone showed profound suppression.

    In plain wordsIn healthy females receiving ganirelix, luteinizing hormone showed profound suppression.

    Peptide
    Ganirelix
    Outcome
    DecreaseLH suppression
    Study

    n = 16

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

    Source sentences

    Summary
    A profound suppression of luteinizing hormone and follicle stimulating hormone was observed.
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  8. 08HumanNon-randomized trialActivity measurement

    In healthy females receiving ganirelix, follicle stimulating hormone showed profound suppression.

    In plain wordsIn healthy females receiving ganirelix, follicle stimulating hormone showed profound suppression.

    Peptide
    Ganirelix
    Outcome
    DecreaseFSH suppression
    Study

    n = 16

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

    Source sentences

    Summary
    A profound suppression of luteinizing hormone and follicle stimulating hormone was observed.
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  9. 09HumanNon-randomized trialActivity measurement

    In healthy females receiving ganirelix, initially low serum oestradiol remained low throughout the study.

    In plain wordsIn healthy females receiving ganirelix, initially low serum oestradiol remained low throughout the study.

    Peptide
    Ganirelix
    Outcome
    Direction not reportedOestradiol concentrations
    Study

    n = 16

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

    Source sentences

    Summary
    Serum oestradiol and progesterone concentrations were relatively low prior to treatment and remained low during the entire study period.
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.
  10. 10HumanNon-randomized trialActivity measurement

    In healthy females receiving ganirelix, initially low serum progesterone remained low throughout the study.

    In plain wordsIn healthy females receiving ganirelix, initially low serum progesterone remained low throughout the study.

    Peptide
    Ganirelix
    Outcome
    Direction not reportedProgesterone concentrations
    Study

    n = 16

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

    Source sentences

    Summary
    Serum oestradiol and progesterone concentrations were relatively low prior to treatment and remained low during the entire study period.
    2 context sentences
    Summary · context
    was evaluated in a randomized, crossover study in 16 healthy females.
    Summary · context
    Two milligrams of ganirelix was administered s.c. once daily for 7 days by Medi-Jector or conventional needle in a randomized sequence, without a washout period.

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, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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