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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.
The primary goal of this protocol is to model change in oxytocin concentrations in plasma after intravenous administration, (oxytocin (Pitocin®), 10 IU) the investigators will also acquire tests of sensory function that could be modulated by oxytocin during later time periods when blood samples are widely separated by time. There are two measures which will assess two different aspects of sensory function.
MEASURE 1: Light Touch Frequency Threshold Light touch is subserved by a group of myelinated peripheral nerves with fast conduction in the Aβ range and which are capable of following high frequencies, being responsible for the sensation of vibration. This capability of individual nerve fibers to respond with high frequency also underlies our ability to sense a light touch moving across the body surface as in brushing.
In preclinical studies investigators have shown that, following injury, these light touch fibers lose their ability to follow high frequencies and, in some cases, no longer respond to mechanical stimulation at all. Oxytocin, when perfused around the neuronal cell bodies of these Aβ nerve fibers, partially restores their function, including their response to high frequency stimulation.
In order to determine the highest frequency that Aβ nerve fibers can respond to, the investigators have created a simple device that produces an oscillatory / vibratory stimulus which can be used on the hand. The subject places fingertips, palm, and volar aspect of the wrist sequentially and the device is set to slowly decrease the frequency of vibration from 1 kilohertz (kHz) until the participant first perceives this. This is repeated three times at each site and takes under 5 minutes in total.
The investigators anticipate that oxytocin will have no effect on normal Aβ fibers and that this measure will not change after oxytocin administration. This will provide important data to contrast with the expected efficacy of oxytocin in the setting of injury, to be studied in subsequent protocols.
MEASURE 2: Sustained Heat As part of a protocol used by the investigators in several studies, the surface of the skin of the forearm or leg is heated to 45°C using a computer-controlled thermode for a period of 5 minutes. This typically results in a slowly increasing pain experience, peaking at 5 minutes in the mild to low moderate range and has been tolerated by more than 150 subjects in studies over the past 14 years.
In an interim analysis of an ongoing clinical study in volunteers, the investigators noted that spinal injection of oxytocin, 15 μg (equivalent to 9 IU), that pain from this sustained heat was dramatically reduced over the 5 minutes of stimulus presentation. In contrast, spinal oxytocin had no effect on the stimulus-response relationship of pain to noxious heat over a 42-50°C range when the stimuli were presented for only 5 seconds. These data suggest that oxytocin reduces C-fiber mediated signaling of sustained heat pain, likely through a spinal site of action.
Drugs administered spinally have a much higher concentration in cerebrospinal fluid than plasma. Nonetheless, spinally administered drugs are typically absorbed to an extent and with a time course similar to that after intramuscular injection, and it is conceivable that the effect on sustained heat pain investigators are seeing in the spinal study reflect peripheral effects via systemic absorption. Thus, if the investigators see a similar reduction in response to sustained heat in this protocol of intravenous administration, the investigators will conclude that oxytocin is more likely activating peripherally than spinally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin (Pitocin®), 10 IU | Other | Oxytocin 10 IU administered once per intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Single IV administration of oxytocin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 2 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 5 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 10 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 15 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 30 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 45 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 60 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | 5 minutes |
| Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Eisenach, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40121179 | Derived | Shafer SL, Ririe DG, Miller S, Curry RS, Hsu DT, Sullivan GM, Eisenach JC. Plasma pharmacokinetics of intravenous and intranasal oxytocin in nonpregnant adults. Br J Anaesth. 2025 May;134(5):1513-1522. doi: 10.1016/j.bja.2024.12.046. Epub 2025 Mar 21. |
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None. All enrolled subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin (Pitocin®), 10 IU | Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin (Pitocin®), 10 IU | Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 2 minutes |
|
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin (Pitocin®), 10 IU | This 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial flushing | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment | Sensation of facial flushing lasting 2-12 minutes without visual appearance of flushing |
Technical failure in one individual resulting in uninterpretable pain scores to sustained heat as a secondary outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Eisenach | Wake Forest Health Sciences | 3367164182 | eisenach@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2019 | Jan 29, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 19, 2020 | Aug 18, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Single intravenous administration of oxytocin (Pitocin®), 10 IU
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| 90 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 120 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 180 minutes |
| Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | 240 minutes |
| 20 minutes |
| Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | 45 minutes |
| Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | 60 minutes |
| Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | 120 minutes |
| Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | 180 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 31 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 32 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 33 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 34 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 35 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 61 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 62 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 63 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 64 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 65 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 121 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 122 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 123 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 124 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 125 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 181 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 182 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 183 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 184 minutes |
| Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | 185 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Light Touch Frequency Threshold | The frequency at which the vibration is perceived before intravenous oxytocin administration | Mean | Standard Deviation | Hz |
|
| Sustained heat | 0-10 verbal pain score to a 45 degree Celsius stimulus before intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving only 10 evaluable | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 5 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 10 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 15 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 30 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 45 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 60 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 90 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | Posted | Mean | Standard Deviation | pg/ml | 120 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | In 7 subjects oxytocin concentration was below the limit of detection (1 pg/ml) | Posted | Mean | Standard Deviation | pg/ml | 180 minutes |
|
|
|
| Primary | Oxytocin Concentration | Plasma concentrations of oxytocin at defined times after intravenous infusion | In 9 subjects oxytocin concentration was below the limit of detection (1 pg/ml) | Posted | Mean | Standard Deviation | pg/ml | 240 minutes |
|
|
|
| Secondary | Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | Posted | Mean | Standard Deviation | Hz | 5 minutes |
|
|
|
|
| Secondary | Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | Posted | Mean | Standard Deviation | Hz | 20 minutes |
|
|
|
| Secondary | Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | Posted | Mean | Standard Deviation | Hz | 45 minutes |
|
|
|
| Secondary | Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | Posted | Mean | Standard Deviation | Hz | 60 minutes |
|
|
|
| Secondary | Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | Posted | Mean | Standard Deviation | Hz | 120 minutes |
|
|
|
| Secondary | Light Touch Frequency Threshold | The frequency at which the vibration is perceived after intravenous oxytocin administration | Posted | Mean | Standard Deviation | Hz | 180 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 31 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 32 minutes |
|
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 33 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 34 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 35 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 61 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 62 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 63 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 64 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 65 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 121 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 122 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 123 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 124 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 125 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 181 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 182 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 183 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 184 minutes |
|
|
|
| Secondary | Sustained Heat | 0-10 verbal pain score to a 45 degree Celsius stimulus after intravenous oxytocin administration; higher score denotes worse outcome. | Technical failure in one subject, leaving 10 evaluable | Posted | Mean | Standard Deviation | score on a scale | 185 minutes |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 7 |
| 11 |
|
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment | Mild headache lasting 2-12 min after oxytocin administration |
|
| Increased heart rate | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment | Sensation of increased heart rate or heart pounding, but not accompanied by tachycardia or hypertension by direct measurement |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |