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Study · Non-randomized trial · n = 24 · 1997

7 results

Pharmacokinetics of triptorelin after intravenous bolus administration in healthy males and in males with renal or hepatic insufficiency.

Müller FO, Terblanchè J, Schall R, van Zyl Smit R, Tucker T, Marais K, Groenewoud G, Porchet HC, Weiner M, Hawarden D

British journal of clinical pharmacology1 Oct 1997Cited by 22 (Europe PMC)

PMID9354307 (opens in a new tab)PMCIDPMC2042859 (opens in a new tab)DOI10.1046/j.1365-2125.1997.t01-1-00592.x (opens in a new tab)PepBankPUB-09354307
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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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In men, maximum triptorelin concentrations were similar across healthy, renal impairment and hepatic impairment groups.

    In plain wordsIn men, peak triptorelin levels were similar across healthy, kidney impairment and liver impairment groups.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    No significant changeMaximum concentration
    Study

    n = 24

    Comparator
    Healthy, renal impairment and hepatic impairment groups
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg single bolus · intravenousAs given in this study (human).

    Measurements

    Geometric mean Cmax
    41.6 to 53.9 mg ml(-1)
    range across four groups

    Source sentences

    Summary
    The maximum concentrations of triptorelin were found to be similar for all four study groups (geometric mean Cmax between 41.6 mg ml(-1) and 53.9 mg ml(-1)).
    1 context sentence
    Summary · context
    This was an open study to determine the pharmacokinetics of a single i.v. bolus dose of 0.5 mg triptorelin acetate in four groups of six male subjects; namely in healthy subjects (Group I), in patients with varying degrees of renal insufficiency (Groups II and III), and in patients with hepatic insu…
  2. 02HumanNon-randomized trialPharmacokinetics

    In men, triptorelin clearance decreased with renal impairment and was lowest with hepatic insufficiency.

    In plain wordsIn men, triptorelin clearance decreased with kidney impairment and was lowest with liver impairment.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    DecreaseTotal clearance
    Study

    n = 24

    Comparator
    Healthy men and renal impairment groups
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg single bolus · intravenousAs given in this study (human).

    Measurements

    Geometric mean clearance
    210 ml min(-1)
    healthy Group I
    Geometric mean clearance
    113 ml min(-1)
    renal Group II
    Geometric mean clearance
    86.8 ml min(-1)
    renal Group III
    Geometric mean clearance
    57.3 ml min(-1)
    hepatic Group IV

    Source sentences

    Summary
    The total clearance of triptorelin decreased with increasing renal impairment, and was even lower in patients with hepatic insufficiency (geometric mean CLtot: 210 ml min(-1), 113 ml min(-1), 86.8 ml min(-1) and 57.3 ml min(-1) for Groups I, II, III and IV, respectively).
    1 context sentence
    Summary · context
    This was an open study to determine the pharmacokinetics of a single i.v. bolus dose of 0.5 mg triptorelin acetate in four groups of six male subjects; namely in healthy subjects (Group I), in patients with varying degrees of renal insufficiency (Groups II and III), and in patients with hepatic insu…
  3. 03HumanNon-randomized trialPharmacokinetics

    In men across all four groups, a three-compartment model adequately described serum triptorelin concentrations.

    In plain wordsIn men across all four groups, a three-compartment model adequately described blood triptorelin levels.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    Not applicableConcentration model
    Study

    n = 24

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg single bolus · intravenousAs given in this study (human).

    Source sentences

    Summary
    Serum triptorelin concentrations in all four groups were adequately described by a three-compartment model.
    1 context sentence
    Summary · context
    This was an open study to determine the pharmacokinetics of a single i.v. bolus dose of 0.5 mg triptorelin acetate in four groups of six male subjects; namely in healthy subjects (Group I), in patients with varying degrees of renal insufficiency (Groups II and III), and in patients with hepatic insu…
  4. 04HumanNon-randomized trialPharmacokinetics

    In men with renal or hepatic impairment, triptorelin elimination half-life was significantly longer than in healthy volunteers.

    In plain wordsIn men with kidney or liver impairment, triptorelin elimination took longer than in healthy volunteers.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    IncreaseElimination half-life versus healthy men
    Study

    n = 24

    Comparator
    Healthy volunteers
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg single bolus · intravenousAs given in this study (human).

    Measurements

    Elimination half-life
    6.6 h
    renal Group II
    Elimination half-life
    7.7 h
    renal Group III
    Elimination half-life
    7.6 h
    hepatic Group IV
    Elimination half-life
    2.8 h
    healthy Group I

    Source sentences

    Summary
    The elimination half-life for patients with hepatic impairment was similar to that of patients with renal impairment (geometric mean t(1/2, z): 6.6 h, 7.7 h and 7.6 h for Groups II, III and IV, respectively), but significantly longer than in healthy volunteers (2.8 h for Group I).
    1 context sentence
    Summary · context
    This was an open study to determine the pharmacokinetics of a single i.v. bolus dose of 0.5 mg triptorelin acetate in four groups of six male subjects; namely in healthy subjects (Group I), in patients with varying degrees of renal insufficiency (Groups II and III), and in patients with hepatic insu…
  5. 05HumanNon-randomized trialPharmacokinetics

    In men, the first triptorelin distribution half-life was similar across the four study groups.

    In plain wordsIn men, the first distribution half-life of triptorelin was similar across the four study groups.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    No significant changeFirst distribution half-life
    Study

    n = 24

    Comparator
    Four study groups
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg single bolus · intravenousAs given in this study (human).

    Measurements

    First distribution half-life
    ≈ 0.1 h
    four groups

    Source sentences

    Summary
    The first and second distribution half-lives were similar for the four groups studied, with geometric mean distribution half-lives of about 0.1 h (6 min) and 0.75 h (45 min), respectively.
    1 context sentence
    Summary · context
    This was an open study to determine the pharmacokinetics of a single i.v. bolus dose of 0.5 mg triptorelin acetate in four groups of six male subjects; namely in healthy subjects (Group I), in patients with varying degrees of renal insufficiency (Groups II and III), and in patients with hepatic insu…
  6. 06HumanNon-randomized trialPharmacokinetics

    In men, the second triptorelin distribution half-life was similar across the four study groups.

    In plain wordsIn men, the second distribution half-life of triptorelin was similar across the four study groups.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    No significant changeSecond distribution half-life
    Study

    n = 24

    Comparator
    Four study groups
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg single bolus · intravenousAs given in this study (human).

    Measurements

    Second distribution half-life
    ≈ 0.75 h
    four groups

    Source sentences

    Summary
    The first and second distribution half-lives were similar for the four groups studied, with geometric mean distribution half-lives of about 0.1 h (6 min) and 0.75 h (45 min), respectively.
    1 context sentence
    Summary · context
    This was an open study to determine the pharmacokinetics of a single i.v. bolus dose of 0.5 mg triptorelin acetate in four groups of six male subjects; namely in healthy subjects (Group I), in patients with varying degrees of renal insufficiency (Groups II and III), and in patients with hepatic insu…
  7. 07HumanNon-randomized trialPharmacokinetics

    In men with hepatic impairment, triptorelin elimination half-life was similar to that in men with renal impairment.

    In plain wordsIn men with liver impairment, triptorelin elimination took a similar time to that in men with kidney impairment.

    Peptide
    Triptorelin (Trelstar, Decapeptyl)
    Outcome
    No significant changeElimination half-life hepatic versus renal impairment
    Study

    n: not reported in source

    Comparator
    Renal impairment
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg single bolus · intravenousAs given in this study (human).

    Measurements

    Elimination half-life
    6.6 h
    renal Group II
    Elimination half-life
    7.7 h
    renal Group III
    Elimination half-life
    7.6 h
    hepatic Group IV

    Source sentences

    Summary
    The elimination half-life for patients with hepatic impairment was similar to that of patients with renal impairment (geometric mean t(1/2, z): 6.6 h, 7.7 h and 7.6 h for Groups II, III and IV, respectively), but significantly longer than in healthy volunteers (2.8 h for Group I).
    1 context sentence
    Summary · context
    This was an open study to determine the pharmacokinetics of a single i.v. bolus dose of 0.5 mg triptorelin acetate in four groups of six male subjects; namely in healthy subjects (Group I), in patients with varying degrees of renal insufficiency (Groups II and III), and in patients with hepatic insu…

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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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

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