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Study · Randomized controlled trial · n = 15 · 2017

5 results

Safety, Tolerability and Pharmacokinetics of Single Doses of Oxytocin Administered via an Inhaled Route in Healthy Females: Randomized, Single-blind, Phase 1 Study.

Fernando D, Siederer S, Singh S, Schneider I, Gupta A, Powell M, Richards D, McIntosh MP, Lambert P, Fowles S

EBioMedicine22 Jul 2017Cited by 17 (Europe PMC)

PMID28781129 (opens in a new tab)PMCIDPMC5552226 (opens in a new tab)DOI10.1016/j.ebiom.2017.07.020 (opens in a new tab)PepBankPUB-28781129
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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: CC BY-NC-ND. 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 trialPharmacokinetics

    In healthy women, inhaled oxytocin at all doses gave plasma concentration profiles of similar shape to intramuscular oxytocin.

    In plain wordsIn healthy women, inhaled oxytocin at all doses gave a blood level pattern similar in shape to the injected form.

    Peptide
    Oxytocin
    Outcome
    Not applicableShape of plasma PK profile, inhaled versus intramuscular
    Study

    n = 15

    Comparator
    Intramuscular oxytocin 10 IU
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    IH 50-600 μg; IM 10 IU · inhaled and intramuscularAs given in this study (human).

    Source sentences

    Summary
    IH (all doses) and IM oxytocin PK profiles were comparable in shape.
    1 context sentence
    Summary · context
    This phase 1, randomized, single-center, single-blind, dose-escalation, fixed-sequence study (NCT02542813) was conducted in healthy, premenopausal, non-pregnant, non-lactating women aged 18-45years.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy women, systemic exposure with inhaled oxytocin 400 μg most closely matched intramuscular oxytocin 10 IU.

    In plain wordsIn healthy women, the 400 μg inhaled dose gave blood exposure closest to the 10 IU injection.

    Peptide
    Oxytocin
    Outcome
    Not applicableSystemic exposure matching to IM oxytocin 10 IU
    Study

    n = 15

    Comparator
    Intramuscular oxytocin 10 IU
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    IH 400 μg; IM 10 IU · inhaled and intramuscularAs given in this study (human).

    Measurements

    Inhaled dose most closely matching IM exposure
    400 μg
    IH oxytocin
    IM comparator dose
    10 IU
    IM oxytocin

    Source sentences

    Summary
    However, systemic exposure with IH oxytocin 400μg most closely matched IM oxytocin 10IU.
    1 context sentence
    Summary · context
    This phase 1, randomized, single-center, single-blind, dose-escalation, fixed-sequence study (NCT02542813) was conducted in healthy, premenopausal, non-pregnant, non-lactating women aged 18-45years.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy women, systemic exposure was approximately dose proportional for inhaled oxytocin.

    In plain wordsIn healthy women, blood exposure to inhaled oxytocin rose roughly in line with the dose.

    Peptide
    Oxytocin
    Outcome
    Not applicableDose proportionality of systemic exposure, inhaled oxytocin
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    IH 200-600 μg · inhaledAs given in this study (human).

    Source sentences

    Summary
    Systemic exposure was approximately dose proportional for IH oxytocin.
    1 context sentence
    Summary · context
    This phase 1, randomized, single-center, single-blind, dose-escalation, fixed-sequence study (NCT02542813) was conducted in healthy, premenopausal, non-pregnant, non-lactating women aged 18-45years.
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy women, no serious adverse events were reported with inhaled or intramuscular oxytocin.

    In plain wordsIn healthy women, no serious side effects were reported with inhaled or injected oxytocin.

    Peptide
    Oxytocin
    Outcome
    No significant changeSerious adverse events
    Study

    n = 15

    Outcome group
    Adverse events · Whole body
    Studied dose
    IH 50-600 μg; IM 10 IU · inhaled and intramuscularAs given in this study (human).

    Source sentences

    Summary
    No serious AEs were reported.
    1 context sentence
    Summary · context
    This phase 1, randomized, single-center, single-blind, dose-escalation, fixed-sequence study (NCT02542813) was conducted in healthy, premenopausal, non-pregnant, non-lactating women aged 18-45years.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy women, no clinically significant findings were observed for any safety parameter after inhaled or intramuscular oxytocin.

    In plain wordsIn healthy women, safety checks showed no clinically significant findings after inhaled or injected oxytocin.

    Peptide
    Oxytocin
    Outcome
    No significant changeClinically significant safety findings (laboratory, vital signs, ECG, spirometry)
    Study

    n = 15

    Outcome group
    Adverse events · Whole body
    Studied dose
    IH 50-600 μg; IM 10 IU · inhaled and intramuscularAs given in this study (human).

    Source sentences

    Summary
    No clinically significant findings were observed for any safety parameters.
    2 context sentences
    Summary · context
    Adverse events (AEs), spirometry, laboratory tests, vital signs, electrocardiograms, physical examinations, and cardiac telemetry were assessed.
    Summary · context
    This phase 1, randomized, single-center, single-blind, dose-escalation, fixed-sequence study (NCT02542813) was conducted in healthy, premenopausal, non-pregnant, non-lactating women aged 18-45years.

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)

CompletedPhase 1NCT02542813

Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers

GlaxoSmithKlinen = 1614 Sept 2015 to 16 Dec 2015

Postpartum Hemorrhage

Trial pageClinicalTrials.govUpdated 19 Oct 2017

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

    11 Oct 2026, 01:30 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 02:49 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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