Trial Outcomes & Findings for PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers (NCT NCT03929367)

NCT ID: NCT03929367

Last Updated: 2021-05-13

Results Overview

Plasma concentrations of oxytocin at defined times after intravenous infusion

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 2 minutes
• Results posted on: 2021-05-13

Participant Flow

None. All enrolled subjects completed the study.

Participant milestones

Measure	Oxytocin (Pitocin®), 10 IU Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Technical failure in one subject, leaving only 10 evaluable

Baseline characteristics by cohort

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Age, Continuous	38 years STANDARD_DEVIATION 13 • n=11 Participants
Sex: Female, Male Female	6 Participants n=11 Participants
Sex: Female, Male Male	5 Participants n=11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants
Race (NIH/OMB) Asian	0 Participants n=11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	0 Participants n=11 Participants
Race (NIH/OMB) White	11 Participants n=11 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
Region of Enrollment United States	11 participants n=11 Participants
BMI	29 kg/m^2 STANDARD_DEVIATION 3.4 • n=11 Participants
Height	173 cm STANDARD_DEVIATION 6.5 • n=11 Participants
Weight	86 kg STANDARD_DEVIATION 11 • n=11 Participants
Light Touch Frequency Threshold	731 Hz STANDARD_DEVIATION 155 • n=11 Participants
Sustained heat One minute	.36 units on a scale STANDARD_DEVIATION .21 • n=10 Participants • Technical failure in one subject, leaving only 10 evaluable
Sustained heat Two minutes	.68 units on a scale STANDARD_DEVIATION .32 • n=10 Participants • Technical failure in one subject, leaving only 10 evaluable
Sustained heat Three minutes	.64 units on a scale STANDARD_DEVIATION .29 • n=10 Participants • Technical failure in one subject, leaving only 10 evaluable
Sustained heat Four minutes	.82 units on a scale STANDARD_DEVIATION .25 • n=11 Participants • Technical failure in one subject, leaving only 10 evaluable
Sustained heat Five minutes	1.32 units on a scale STANDARD_DEVIATION .3 • n=10 Participants • Technical failure in one subject, leaving only 10 evaluable

PRIMARY outcome

Timeframe: 2 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	1047 pg/ml Standard Deviation 556

PRIMARY outcome

Timeframe: 5 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	587 pg/ml Standard Deviation 257

PRIMARY outcome

Timeframe: 10 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	322 pg/ml Standard Deviation 136

PRIMARY outcome

Timeframe: 15 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	202 pg/ml Standard Deviation 91

PRIMARY outcome

Timeframe: 30 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	82 pg/ml Standard Deviation 40

PRIMARY outcome

Timeframe: 45 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	41 pg/ml Standard Deviation 20

PRIMARY outcome

Timeframe: 60 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	25 pg/ml Standard Deviation 13

PRIMARY outcome

Timeframe: 90 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	10 pg/ml Standard Deviation 5.6

PRIMARY outcome

Timeframe: 120 minutes

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	6.2 pg/ml Standard Deviation 3.6

PRIMARY outcome

Timeframe: 180 minutes

Population: In 7 subjects oxytocin concentration was below the limit of detection (1 pg/ml)

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=4 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	2.5 pg/ml Standard Deviation 1.6

PRIMARY outcome

Timeframe: 240 minutes

Population: In 9 subjects oxytocin concentration was below the limit of detection (1 pg/ml)

Plasma concentrations of oxytocin at defined times after intravenous infusion

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=2 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Oxytocin Concentration	1.0 pg/ml Standard Deviation 1.5

SECONDARY outcome

Timeframe: 5 minutes

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Light Touch Frequency Threshold	722 Hz Standard Deviation 141

SECONDARY outcome

Timeframe: 20 minutes

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Light Touch Frequency Threshold	710 Hz Standard Deviation 130

SECONDARY outcome

Timeframe: 45 minutes

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Light Touch Frequency Threshold	732 Hz Standard Deviation 128

SECONDARY outcome

Timeframe: 60 minutes

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Light Touch Frequency Threshold	727 Hz Standard Deviation 127

SECONDARY outcome

Timeframe: 120 minutes

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Light Touch Frequency Threshold	693 Hz Standard Deviation 154

SECONDARY outcome

Timeframe: 180 minutes

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=11 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Light Touch Frequency Threshold	771 Hz Standard Deviation 99

SECONDARY outcome

Timeframe: 31 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	0.36 score on a scale Standard Deviation .21

SECONDARY outcome

Timeframe: 32 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.14 score on a scale Standard Deviation .14

SECONDARY outcome

Timeframe: 33 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.32 score on a scale Standard Deviation .2

SECONDARY outcome

Timeframe: 34 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.32 score on a scale Standard Deviation .2

SECONDARY outcome

Timeframe: 35 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.64 score on a scale Standard Deviation .29

SECONDARY outcome

Timeframe: 61 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.45 score on a scale Standard Deviation .33

SECONDARY outcome

Timeframe: 62 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.23 score on a scale Standard Deviation .13

SECONDARY outcome

Timeframe: 63 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.27 score on a scale Standard Deviation .15

SECONDARY outcome

Timeframe: 64 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.36 score on a scale Standard Deviation .16

SECONDARY outcome

Timeframe: 65 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.73 score on a scale Standard Deviation .25

SECONDARY outcome

Timeframe: 121 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.36 score on a scale Standard Deviation .21

SECONDARY outcome

Timeframe: 122 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.23 score on a scale Standard Deviation .13

SECONDARY outcome

Timeframe: 123 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.18 score on a scale Standard Deviation .19

SECONDARY outcome

Timeframe: 124 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.27 score on a scale Standard Deviation .2

SECONDARY outcome

Timeframe: 125 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.77 score on a scale Standard Deviation .37

SECONDARY outcome

Timeframe: 181 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.27 score on a scale Standard Deviation .2

SECONDARY outcome

Timeframe: 182 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.18 score on a scale Standard Deviation .13

SECONDARY outcome

Timeframe: 183 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.32 score on a scale Standard Deviation .15

SECONDARY outcome

Timeframe: 184 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.59 score on a scale Standard Deviation .21

SECONDARY outcome

Timeframe: 185 minutes

Population: Technical failure in one subject, leaving 10 evaluable

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

Outcome measures

Measure	Oxytocin (Pitocin®), 10 IU n=10 Participants Oxytocin 10 IU administered once per intravenous injection Oxytocin: Single IV administration of oxytocin
Sustained Heat	.86 score on a scale Standard Deviation .22

Adverse Events

Oxytocin (Pitocin®), 10 IU

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oxytocin (Pitocin®), 10 IU n=11 participants at risk 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.
Cardiac disorders Facial flushing	63.6% 7/11 • Number of events 7 • 1 day
Nervous system disorders Headache	27.3% 3/11 • Number of events 3 • 1 day
Cardiac disorders Increased heart rate	27.3% 3/11 • Number of events 3 • 1 day

Additional Information

Dr. James Eisenach

Wake Forest Health Sciences

Phone: 3367164182

Email: eisenach@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place