Primary outcomeMean· 2 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated
| Group | Value (picograms/ml of oxytocin) | Spread |
|---|---|---|
| Oxytocin Administration (Intravenous, Then Intranasal) | 105 | 47 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataA Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 25 participants (actual)
- Sponsor
- Wake Forest University Health Sciences · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 27 Feb 2023
- Primary completion
- 1 Nov 2023
- Completion
- 1 Nov 2023
- First posted
- 5 Jan 2023
- Last update posted
- 17 Feb 2025
- Conditions
- Healthy Volunteer Study
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20232024
- Ph 1
A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects
NCT0567266727 Feb 2023 to 1 Nov 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The main purpose of this study is to sample blood and model the plasma pharmacokinetics (PK) of a single dose of intravenous (IV) oxytocin and a single dose of intranasal (i.n.) oxytocin. This is an unblinded study of subjects, all of whom will receive an intravenous (IV) infusion and intranasal (i.n.) dose of oxytocin (a naturally occurring hormone that is made in the brain) with blood samples taken thereafter in order to create a formula to describe the concentrations of oxytocin in the blood over time (pharmacokinetics). In this study healthy volunteers and people are recruited for a two day study. Each study participant will have 2 IV catheters placed (one in each arm) for the day of IV oxytocin dosing and 1 IV catheter on the day of i.n. oxytocin dosing. After placement of the IV catheters, an infusion of oxytocin will be given over a 30 minute period. Blood samples will be taken after the infusion begins and several times during and after the infusion. The blood will be drawn through the IV catheter not used for the oxytocin infusion. For the intranasal oxytocin administration day, 1 IV catheter will be placed and several blood samples will be taken after administration.
Interventions
- intravenous oxytocinDrug
- intranasal oxytocinDrug
Arms1
Experimental
Oxytocin Administration (Intravenous, then Intranasal)
Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Primary outcomes21
Outcomes the sponsor listed as primary.
Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated
Time frame · 2 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 5 Minutes After Infusion Initiated
Time frame · 5 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated
Time frame · 10 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 20 Minutes After Infusion Initiated
Time frame · 20 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 30 Minutes After Infusion Initiated
Time frame · 30 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 40 Minutes After Infusion Initiated
Time frame · 40 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 50 Minutes After Infusion Initiated
Time frame · 50 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 65 Minutes After Infusion Initiated
Time frame · 65 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 90 Minutes After Infusion Initiated
Time frame · 90 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 120 Minutes After Infusion Initiated
Time frame · 120 minutes after oxytocin infusion initiated
Registry description
Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 1 Minute After First Intranasal Puffs
Time frame · 1 minute after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 2 Minutes After First Intranasal Puffs
Time frame · 2 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 5 Minutes After First Intranasal Puffs
Time frame · 5 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 7 Minutes After First Intranasal Puffs
Time frame · 7 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 10 Minutes After First Intranasal Puffs
Time frame · 10 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 15 Minutes After First Intranasal Puffs
Time frame · 15 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 20 Minutes After First Intranasal Puffs
Time frame · 20 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 25 Minutes After First Intranasal Puffs
Time frame · 25 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 35 Minutes After First Intranasal Puffs
Time frame · 35 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 45 Minutes After First Intranasal Puffs
Time frame · 45 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
Plasma Oxytocin Concentration 60 Minutes After First Intranasal Puffs
Time frame · 60 minutes after intranasal oxytocin administration
Registry description
Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration
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· 5 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 5 Minutes After Infusion Initiated
| Group | Value (picograms/ml of oxytocin) | Spread |
|---|---|---|
| Oxytocin Administration (Intravenous, Then Intranasal) | 257 | 80 |
Primary outcomeMean· 10 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated
| Group | Value (picograms/ml of oxytocin) | Spread |
|---|---|---|
| Oxytocin Administration (Intravenous, Then Intranasal) | 365 | 77 |
Primary outcomeMean· 20 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 20 Minutes After Infusion Initiated
| Group | Value (picograms/ml of oxytocin) | Spread |
|---|---|---|
| Oxytocin Administration (Intravenous, Then Intranasal) | 452 | 89 |
Primary outcomeMean· 30 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 30 Minutes After Infusion Initiated
| Group | Value (picograms/ml of oxytocin) | Spread |
|---|---|---|
| Oxytocin Administration (Intravenous, Then Intranasal) | 462 | 139 |
Primary outcomeMean· 40 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 40 Minutes After Infusion Initiated
| Group | Value (picograms/ml of oxytocin) | Spread |
|---|---|---|
| Oxytocin Administration (Intravenous, Then Intranasal) | 193 | 79 |
Primary outcomeMean· 50 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 50 Minutes After Infusion Initiated
| Group | Value (picograms/ml of oxytocin) | Spread |
|---|---|---|
| Oxytocin Administration (Intravenous, Then Intranasal) | 118 | 73 |
Primary outcomeMean· 65 minutes after oxytocin infusion initiated
Plasma Oxytocin Concentration 65 Minutes After Infusion Initiated
| Group | Value (picograms/ml of oxytocin) | Spread |
|---|---|---|
| Oxytocin Administration (Intravenous, Then Intranasal) | 51 | 21 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Intravenous Oxytocin Infusion Study DayOxytocin 14 micrograms infusion over 30 minutes on first study day. | 0 / 24 | 0 / 24 | 4 / 24 |
| Intranasal Oxytocin Spray Study DayOxytocin 102 micrograms by intranasal spray on second study day. | 0 / 24 | 0 / 24 | 3 / 24 |
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
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Male or female \> 18 and \< 75 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 1 or 2.
* For healthy volunteers, normal blood pressure (systolic 100-140 mmHg; diastolic 60-90 mmHg) resting heart rate 45-90 beats per minute) without medication. For those with hypertension, blood pressure controlled with anti-hypertensive medication and with a resting heart rate 45-100 beats per minute.
* 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 (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
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 urine pregnancy test at visit 1), women who are currently nursing or lactating, women that have been pregnant within 2 years
* Subjects with neuropathy, chronic pain (being treated on a daily basis), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
* Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
* Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, Selective serotonin reuptake inhibitors (SSRI's) , Monoamine oxidase inhibitors (MAOI), or the recreational drug ecstasy.
* Subjects with a known latex allergy.
* History of chronic nasal obstruction or local pathology in nostril pathway which, in the opinion of the investigator, would prevent appropriate nasal administration of the study drug.
* Use of over the counter nasal products (ie. Saline spray, Neti-Pot, etc.) or intranasal corticosteroid medications during the study.
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