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Study · Randomized controlled trial · n = 95 · 2021

8 results

Safety and tolerability of chronic intranasal oxytocin in older men: results from a randomized controlled trial.

Rung JM, Horta M, Tammi EM, Perez E, Ojeda MC, Lin T, Harris G, Somerville J, Salmeron D, Beltz SE, Sandesara B, Feifel D, Ebner NC

Psychopharmacology12 May 2021Cited by 17 (Europe PMC)

PMID33982141 (opens in a new tab)PMCIDPMC8115997 (opens in a new tab)DOI10.1007/s00213-021-05862-3 (opens in a new tab)PepBankPUB-33982141
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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.

  1. 01HumanRandomized controlled trialSafety outcome

    In older men, 4 weeks of intranasal oxytocin had no significant impact on cardiovascular measures (heart rate, blood pressure).

    In plain wordsIn older men, 4 weeks of oxytocin did not significantly change heart rate or blood pressure compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeHeart rate and blood pressure
    Study

    n = 95

    Comparator
    Placebo
    Outcome group
    Blood pressure · Cardiovascular
    Studied dose
    24 IU twice daily · intranasal · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    OT had no significant impact on cardiovascular, urine, or serum measures.
    3 context sentences
    Summary · context
    Heart rate, blood pressure, urine osmolality, and serum metabolic biomarkers were obtained before and at the end of the intervention.
    Summary · context
    Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments.
    Summary · context
    Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46).
  2. 02HumanRandomized controlled trialSafety outcome

    In older men, 4 weeks of intranasal oxytocin had no significant impact on urine measures (urine osmolality).

    In plain wordsIn older men, 4 weeks of oxytocin did not significantly change urine concentration compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeUrine osmolality
    Study

    n = 95

    Comparator
    Placebo
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    24 IU twice daily · intranasal · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    OT had no significant impact on cardiovascular, urine, or serum measures.
    3 context sentences
    Summary · context
    Heart rate, blood pressure, urine osmolality, and serum metabolic biomarkers were obtained before and at the end of the intervention.
    Summary · context
    Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments.
    Summary · context
    Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46).
  3. 03HumanRandomized controlled trialSafety outcome

    In older men, 4 weeks of intranasal oxytocin had no significant impact on serum metabolic biomarkers.

    In plain wordsIn older men, 4 weeks of oxytocin did not significantly change blood metabolic markers compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeSerum metabolic biomarkers
    Study

    n = 95

    Comparator
    Placebo
    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    24 IU twice daily · intranasal · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    OT had no significant impact on cardiovascular, urine, or serum measures.
    3 context sentences
    Summary · context
    Heart rate, blood pressure, urine osmolality, and serum metabolic biomarkers were obtained before and at the end of the intervention.
    Summary · context
    Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments.
    Summary · context
    Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46).
  4. 04HumanRandomized controlled trialSafety outcome

    In older men, intranasal oxytocin did not significantly increase the likelihood of reporting adverse events relative to placebo.

    In plain wordsIn older men, oxytocin did not significantly raise the chance of reporting side effects compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeLikelihood of reporting adverse events
    Study

    n = 95

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    24 IU twice daily · intranasal · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Relative to P, OT did not significantly increase the likelihood of reporting AEs
    2 context sentences
    Summary · context
    Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments.
    Summary · context
    Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46).
  5. 05HumanRandomized controlled trialSafety outcome

    In older men, intranasal oxytocin did not significantly increase the number of adverse events relative to placebo.

    In plain wordsIn older men, oxytocin did not significantly raise the number of side effects compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeNumber of adverse events
    Study

    n = 95

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    24 IU twice daily · intranasal · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Relative to P, OT did not significantly increase the likelihood of reporting AEs, nor the number or severity of AEs reported.
    2 context sentences
    Summary · context
    Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments.
    Summary · context
    Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46).
  6. 06HumanRandomized controlled trialSafety outcome

    In older men, intranasal oxytocin did not significantly increase the severity of adverse events relative to placebo.

    In plain wordsIn older men, oxytocin did not significantly raise the severity of side effects compared with placebo.

    Peptide
    Oxytocin
    Outcome
    No significant changeSeverity of adverse events
    Study

    n = 95

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    24 IU twice daily · intranasal · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Relative to P, OT did not significantly increase the likelihood of reporting AEs, nor the number or severity of AEs reported.
    2 context sentences
    Summary · context
    Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments.
    Summary · context
    Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46).
  7. 07HumanRandomized controlled trialSafety outcome

    In older men, adverse events reported with intranasal oxytocin and with placebo were generally mild and few in number.

    In plain wordsIn older men, side effects with oxytocin and with placebo were generally mild and few.

    Peptide
    Oxytocin
    Outcome
    Not applicableAdverse events mild and few
    Study

    n = 95

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    24 IU twice daily · intranasal · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    The AEs reported for both treatments were generally mild and few in number
    2 context sentences
    Summary · context
    Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments.
    Summary · context
    Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46).
  8. 08HumanRandomized controlled trialSafety outcome

    In older men, one participant on intranasal oxytocin dropped out due to adverse events, against two on placebo.

    In plain wordsIn older men, one person on oxytocin and two on placebo dropped out because of side effects.

    Peptide
    Oxytocin
    Outcome
    Not applicableDropout due to adverse events
    Study

    n = 95

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    24 IU twice daily · intranasal · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    one participant assigned to OT and two assigned to P dropped out due to AEs.
    2 context sentences
    Summary · context
    Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments.
    Summary · context
    Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46).

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

    11 Oct 2026, 00:50 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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