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Trial · Interventional

CompletedPhase 4Results postedRegistry data

PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers

NCTNCT03929367 (opens ClinicalTrials.gov in a new tab)Other idIRB00056413
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
11 participants (actual)
Sponsor
Wake Forest University Health Sciences · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
10 May 2019
Primary completion
1 Mar 2020
Completion
1 Mar 2020
First posted
26 Apr 2019
Last update posted
13 May 2021
Conditions
Chronic Pain

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 4

    PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers

    NCT03929367

    10 May 2019 to 1 Mar 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The primary goal of this protocol is to model change in oxytocin concentrations in plasma after intravenous (IV) administration. Additional measurements will be performed on sensory function that could be influenced by oxytocin during later time periods when blood samples are widely separated by time. This protocol will describe the pharmacokinetics (PK) of intravenous oxytocin in healthy adult men and adult,non-pregnant women. PK samples will be obtained after an injection of intravenous oxytocin 10 IU over 60 seconds. Blood will be drawn for the PK samples prior to the oxytocin administration and then 11 times after administration. There are two additional measures which will assess two different aspects of sensory function. MEASURE 1: Light Touch Frequency Threshold In order to determine the highest frequency that specific nerve fibers can respond to, a simple device that produces an oscillatory / vibratory stimulus will be used on the hand. The subject places fingertips, palm, and palm side of the wrist sequentially and the device is set to slowly decrease the frequency of vibration from 1 kHz until the subject first perceives this. This is repeated three times at each site and takes less than 5 minutes in total. This will be performed before the oxytocin administration and 6 times after the administration of IV Oxytocin. MEASURE 2: Sustained Heat The surface of the skin of the forearm or leg is heated to 113°F using a computer controlled thermode for a period of 5 minutes. This will be done before the IV Oxytocin and 4 times after the administration. A set of random thermal temperatures (98°F-122°F) will also be applied to the skin of the leg or forearm before the IV Oxytocin administration and 4 times after administration of IV Oxytocin.

Interventions

  • OxytocinDrug

Arms1

  • Other

    Oxytocin (Pitocin®), 10 IU

    Oxytocin 10 IU administered once per intravenous injection

Primary outcomes11

Outcomes the sponsor listed as primary.

  1. Oxytocin Concentration

    Time frame · 2 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  2. Oxytocin Concentration

    Time frame · 5 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  3. Oxytocin Concentration

    Time frame · 10 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  4. Oxytocin Concentration

    Time frame · 15 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  5. Oxytocin Concentration

    Time frame · 30 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  6. Oxytocin Concentration

    Time frame · 45 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  7. Oxytocin Concentration

    Time frame · 60 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  8. Oxytocin Concentration

    Time frame · 90 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  9. Oxytocin Concentration

    Time frame · 120 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  10. Oxytocin Concentration

    Time frame · 180 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

  11. Oxytocin Concentration

    Time frame · 240 minutes

    Registry description

    Plasma concentrations of oxytocin at defined times after intravenous infusion

Secondary outcomes(20)

  1. Light Touch Frequency Threshold

    Time frame · 5 minutes

    Registry description

    The frequency at which the vibration is perceived after intravenous oxytocin administration

  2. Light Touch Frequency Threshold

    Time frame · 20 minutes

    Registry description

    The frequency at which the vibration is perceived after intravenous oxytocin administration

  3. Light Touch Frequency Threshold

    Time frame · 45 minutes

    Registry description

    The frequency at which the vibration is perceived after intravenous oxytocin administration

  4. Light Touch Frequency Threshold

    Time frame · 60 minutes

    Registry description

    The frequency at which the vibration is perceived after intravenous oxytocin administration

  5. Light Touch Frequency Threshold

    Time frame · 120 minutes

    Registry description

    The frequency at which the vibration is perceived after intravenous oxytocin administration

  6. Light Touch Frequency Threshold

    Time frame · 180 minutes

    Registry description

    The frequency at which the vibration is perceived after intravenous oxytocin administration

  7. Sustained Heat

    Time frame · 31 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  8. Sustained Heat

    Time frame · 32 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  9. Sustained Heat

    Time frame · 33 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  10. Sustained Heat

    Time frame · 34 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  11. Sustained Heat

    Time frame · 35 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  12. Sustained Heat

    Time frame · 61 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  13. Sustained Heat

    Time frame · 62 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  14. Sustained Heat

    Time frame · 63 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  15. Sustained Heat

    Time frame · 64 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  16. Sustained Heat

    Time frame · 65 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  17. Sustained Heat

    Time frame · 121 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  18. Sustained Heat

    Time frame · 122 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  19. Sustained Heat

    Time frame · 123 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

  20. Sustained Heat

    Time frame · 124 minutes

    Registry description

    0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 2 minutes

Oxytocin Concentration

GroupValue (pg/ml)Spread
Oxytocin (Pitocin®), 10 IU1047556
Primary outcomeMean· 5 minutes

Oxytocin Concentration

GroupValue (pg/ml)Spread
Oxytocin (Pitocin®), 10 IU587257
Primary outcomeMean· 10 minutes

Oxytocin Concentration

GroupValue (pg/ml)Spread
Oxytocin (Pitocin®), 10 IU322136
Primary outcomeMean· 15 minutes

Oxytocin Concentration

GroupValue (pg/ml)Spread
Oxytocin (Pitocin®), 10 IU20291
Primary outcomeMean· 30 minutes

Oxytocin Concentration

GroupValue (pg/ml)Spread
Oxytocin (Pitocin®), 10 IU8240
Primary outcomeMean· 45 minutes

Oxytocin Concentration

GroupValue (pg/ml)Spread
Oxytocin (Pitocin®), 10 IU4120
Primary outcomeMean· 60 minutes

Oxytocin Concentration

GroupValue (pg/ml)Spread
Oxytocin (Pitocin®), 10 IU2513
Primary outcomeMean· 90 minutes

Oxytocin Concentration

GroupValue (pg/ml)Spread
Oxytocin (Pitocin®), 10 IU105.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocin (Pitocin®), 10 IUThis was a one day, open-label, single-dose study of intravenous oxytocin for the purpose of estimating plasma pharmacokinetic model parameters in adult men and women. Blood pressure, heart and respiratory rate, and oxyhemoglobin saturation were recorded prior to and at intervals following administration of oxytocin. In addition, subjects were informed to indicate if they had any subjective symptoms.0 / 110 / 117 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2025

4 results

Plasma pharmacokinetics of intravenous and intranasal oxytocin in nonpregnant adults.

Shafer et al. 2025British journal of anaesthesiacited by 6

PMID 40121179PMC12106900DOI 10.1016/j.bja.2024.12.046PUB-40121179

Rights unknown4 results
Source linkSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female \> 18 and \< 60 years of age, Body Mass Index (BMI) \<40. * Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status I or II * Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication * Female subjects of child-bearing potential and those \< 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods Exclusion Criteria: * Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin® * Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data * Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years * Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

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