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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02999100
Registration number
NCT02999100
Ethics application status
Date submitted
1/11/2016
Date registered
21/12/2016
Date last updated
23/03/2020
Titles & IDs
Public title
Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women
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Scientific title
A Randomized, Open-label Study to Characterize the Pharmacokinetics of Inhaled Oxytocin (GR121619) Compared With IM Oxytocin in Women in the Third Stage of Labour, and With IV Oxytocin in Non-pregnant, Non-lactating Women of Childbearing Potential
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Secondary ID [1]
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2016-002672-27
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Secondary ID [2]
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205920
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postpartum Hemorrhage
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Condition category
Condition code
Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IH Oxytocin
Treatment: Drugs - IM Oxytocin
Treatment: Drugs - IV Oxytocin
Treatment: Devices - ROTAHALER
Experimental: Group 1 -IH oxytocin - Women with an uncomplicated pregnancy in third stage of labour will be enrolled in the arm. Subjects will receive 400 micrograms (mcg) IH oxytocin. Subjects will be followed up in-person or via telephone within approximately 24 hr post dose and once between 7 days to 14 days
Experimental: Group 1 -IM oxytocin - Women with an uncomplicated pregnancy in third stage of labour will be enrolled in the arm. Subjects will receive 10 I.U. IM oxytocin. Subjects will be followed up in-person or via telephone within approximately 24 hr post dose and once between 7 days to 14 days
Experimental: Group 2 (IH and IV oxytocin) - Group 2 will enrol healthy, non-pregnant, non-lactating female subjects of childbearing potential, and each subject will participate in 2 dosing sessions. Group 2 will be divided into two cohorts: Cohort A will enrol women on a combined oral contraceptive, and Cohort B will enrol women who are not using a hormonal form of contraceptive. Group 2 subjects will randomized to receive IH oxytocin, and IV oxytocin in a cross fashion. Subjects will be followed up in-person once between 7 days to 21 days
Treatment: Drugs: IH Oxytocin
Oxytocin will be supplied as colourless and clear hard capsule with powder blend for inhalation with unit dose strength 400 mcg and 200 mcg. It will be administered using ROTAHALER dry powder inhaler (DPI).
Treatment: Drugs: IM Oxytocin
Oxytocin will be supplied for solution for infusion in 1ml ampoule containing colourless and clear sterile solution with unit dose strength 5 I.U./mL, or 10 I.U./mL for IM administration
Treatment: Drugs: IV Oxytocin
Oxytocin will be supplied as solution for infusion in 1ml ampoule containing colourless and clear sterile solution to be administered as a 30-second IV bolus with unit dose strength 5 I.U./mL, or 10 I.U./mL.
Treatment: Devices: ROTAHALER
ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Plasma Concentration Time Profile of Oxytocin
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Assessment method [1]
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Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [1]
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Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1
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Primary outcome [2]
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Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin
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Assessment method [2]
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Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [2]
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Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1
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Primary outcome [3]
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Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin
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Assessment method [3]
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Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [3]
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10 minutes post dose Day 1
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Primary outcome [4]
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Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin
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Assessment method [4]
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Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [4]
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20 minutes post dose Day 1
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Primary outcome [5]
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Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin
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Assessment method [5]
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Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [5]
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30 minutes post dose Day 1
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Primary outcome [6]
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Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin
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Assessment method [6]
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Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [6]
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Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1
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Primary outcome [7]
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Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin
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Assessment method [7]
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Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [7]
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Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1
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Primary outcome [8]
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Part 1: Terminal Phase Half-life (t1/2) of Oxytocin
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Assessment method [8]
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Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.
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Timepoint [8]
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Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1
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Primary outcome [9]
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Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
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Assessment method [9]
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An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.
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Timepoint [9]
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Up to 37 days
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Primary outcome [10]
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Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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Assessment method [10]
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Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
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Timepoint [10]
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Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose
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Primary outcome [11]
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Part 2: Change From Baseline in SBP and DBP
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Assessment method [11]
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SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [11]
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Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose
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Primary outcome [12]
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Part 2: Change From Baseline in Heart Rate
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Assessment method [12]
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Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [12]
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Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose
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Primary outcome [13]
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Part 2: Absolute Values of Heart Rate
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Assessment method [13]
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Heart rate was measured in semi-supine position after 5 minutes rest
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Timepoint [13]
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Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose
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Primary outcome [14]
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Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval
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Assessment method [14]
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Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.
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Timepoint [14]
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Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose
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Primary outcome [15]
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Part 2: Number of Participants With Abnormal Respiratory Events
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Assessment method [15]
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Number of participants with abnormal respiratory events has been presented
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Timepoint [15]
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Up to Day 37
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Primary outcome [16]
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Part 2: Forced Expiratory Volume at 1 Minute (FEV1)
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Assessment method [16]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.
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Timepoint [16]
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Pre dose and 1 hour post dose on Day1
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Primary outcome [17]
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Part 2: Percent Oxygen in Blood
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Assessment method [17]
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Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries
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Timepoint [17]
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Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose
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Primary outcome [18]
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Part 2: Absolute Values of Respiration Rate
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Assessment method [18]
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Respiration rate was measured in semi-supine position after 5 minutes rest
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Timepoint [18]
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Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose
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Primary outcome [19]
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Part 2: Plasma Concentration Time Profile of Oxytocin.
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Assessment method [19]
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Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [19]
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-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
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Primary outcome [20]
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Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin
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Assessment method [20]
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Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [20]
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-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
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Primary outcome [21]
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Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin
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Assessment method [21]
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Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [21]
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10 minutes post dose
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Primary outcome [22]
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Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin
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Assessment method [22]
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Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [22]
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20 minutes post dose
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Primary outcome [23]
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Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin
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Assessment method [23]
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Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [23]
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30 minutes post dose
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Primary outcome [24]
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Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin
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Assessment method [24]
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Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [24]
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-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
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Primary outcome [25]
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Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin
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Assessment method [25]
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Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [25]
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-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
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Primary outcome [26]
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Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only
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Assessment method [26]
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Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [26]
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-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
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Primary outcome [27]
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Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only
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Assessment method [27]
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Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [27]
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-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
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Primary outcome [28]
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Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin
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Assessment method [28]
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Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [28]
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-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
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Secondary outcome [1]
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Part 1: Number of Participants With Non-SAEs and SAEs
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Assessment method [1]
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An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
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Timepoint [1]
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Up to 15 days
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Secondary outcome [2]
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Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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Assessment method [2]
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Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
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Timepoint [2]
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30 minutes and 2 hours post dose
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Secondary outcome [3]
0
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Part 1: Absolute Values of Heart Rate
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Assessment method [3]
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Heart rate was measured in semi-supine position after 5 minutes rest
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Timepoint [3]
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30 minutes and 2 hours post dose
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Secondary outcome [4]
0
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Part 1: Absolute Values of Respiration Rate
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Assessment method [4]
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Respiration rate was measured in semi-supine position after 5 minutes rest
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Timepoint [4]
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30 minutes and 2 hours post dose
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Secondary outcome [5]
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Part 1: Absolute Values of Temperature
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Assessment method [5]
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Body temperature was measured in semi-supine position after 5 minutes rest
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Timepoint [5]
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30 minutes and 2 hours post dose
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Secondary outcome [6]
0
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Part 1: Change From Baseline in SBP and DBP
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Assessment method [6]
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SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [6]
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Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose
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Secondary outcome [7]
0
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Part 1: Change From Baseline in Heart Rate
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Assessment method [7]
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Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [7]
0
0
Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose
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Secondary outcome [8]
0
0
Part 1: Change From Baseline in Respiration Rate
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Assessment method [8]
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Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [8]
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0
Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose
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Secondary outcome [9]
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Part 1: Change From Baseline in Body Temperature
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Assessment method [9]
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Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
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Timepoint [9]
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Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose
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Secondary outcome [10]
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Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin
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Assessment method [10]
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Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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Timepoint [10]
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Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1
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Eligibility
Key inclusion criteria
All Groups:
- Between 18 and 40 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a
medical evaluation including medical history, physical examination, and laboratory
tests as required per protocol.
- Subject clinical chemistry and haematology values within an acceptable range for the
population recruited and not of abnormal clinical significance. A subject with a
clinical abnormality or laboratory parameter(s) which is/are not specifically listed
in the inclusion or exclusion criteria, outside the reference range for the population
being studied may be included only if the investigator in consultation with the
Medical Monitor (if required) agree and document that the finding is unlikely to
introduce additional risk factors and will not interfere with the study procedures.
- Adequate peripheral venous access for cannulation.
Group 1 Only:
- Currently pregnant, with an uncomplicated pregnancy as determined by the investigator
or designee.
- Estimated date of delivery within 24 weeks of screening.
- Planned spontaneous vaginal birth and considered by investigator at low risk for post
partum hemorrhage (PPH).
- Planned birth in between the 37th and 42nd week of pregnancy.
- Women who qualify for oxytocin as appropriate for active management of TSL and who
agree to have active management.
Group 2 Only:
- ECG normal, or abnormal and not clinically significant.
- FEV1 >80% of predicted.
- Systolic blood pressure >=90 millimeters of mercury (mmHg).
- Body mass index (BMI) within the range 18 - 32 Kilogram (kg)/square meter (m^2)
(inclusive).
- Sex-Female.
- Group 2, Cohort A Only:
A female subject is eligible to participate if she is confirmed to be not pregnant at
screening and on Day 1 (as confirmed by a negative serum or urine human chorionic
gonadotrophin [hCG] test), not lactating, and the following condition applies:
Is of reproductive potential and agrees to use the same combined estrogen and progestogen
oral contraceptive from 3 months prior to the first dose of study medication and until the
follow-up contact.
This method of contraception is only effective when used consistently, correctly and in
accordance with the product label. The investigator is responsible for ensuring that
subjects understand how to properly use their method of contraception
- Group 2, Cohort B Only:
A female subject is eligible to participate if she is confirmed to be not pregnant at
screening and on Day 1 (as confirmed by a negative serum or urine hCG test), not lactating,
and one of the following conditions applies:
Is of reproductive potential and has been using the same non-hormonal contraceptive method
from 3 months prior to the first dose of study medication and until the follow-up contact.
Would be of reproductive potential, but has undergone bilateral tubal ligation or occlusion
or bilateral salpingectomy at least 12 months prior to first dose of study medication.
Is of reproductive potential with only same sex partners or who are and will continue to be
abstinent from penile-vaginal intercourse on a long term and persistent basis, when this is
their preferred and usual lifestyle. Periodic abstinence (e.g. calendar, ovulation,
symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of
contraception.
These methods of contraception are only effective when used consistently, correctly and in
accordance with the product label. The investigator is responsible for ensuring that
subjects understand how to properly use their method(s) of contraception.
Of Note: Group 2, Cohort B will enrol women of reproductive potential if they agree to use
a nonhormonal contraceptive method from at least one month prior to receiving study drug
and until the follow-up assessment. Although condoms with spermicide are not considered a
highly effective method of contraception, the risk of receiving study drug during pregnancy
is minimal for the following reasons:
Pregnancy testing must be negative at screening and on the first day of dosing. Dosing is
completed no greater than 14 days from the start of dosing. Oxytocin has a well established
rapid half-life. If a patient happened to conceive during the time of dosing, study drug
would be eliminated before implantation would occur.
- All Groups: Capable of giving signed informed consent as described in Protocol which
includes compliance with the requirements and restrictions listed in the consent form
and in this protocol.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
All Groups:
- Postmenopausal as defined by gynaecological history.
- Chronic lung condition of any etiology including asthma, Chronic obstructive pulmonary
disease (COPD), emphysema, interstitial lung disease or active Tuberculosis (TB).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Blood pressure >140 systolic or >90 diastolic.
Group 1 Only:
- Females with planned Caesarean Section.
- Females with significant medical complications as determined by investigator.
Group 2 Only:
- Currently breastfeeding or lactating.
- QT duration corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds
(msec).
- Alanine aminotransferase (ALT) and bilirubin >1.5 Upper Limit of Normal (ULN)
(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
bilirubin <35%).
- Subjects with highly-active or symptomatic gynaecological disorders (such as large
symptomatic fibroids).
All Groups:
- Prescription or non-prescription drugs not approved by the investigator.
- Oxytocin for any reason (including, but not limited to, induction or augmentation of
labour) prior to administration of study-related oxytocin.
- History of regular alcohol consumption within 6 months of the study defined as: An
average weekly intake of >14 units. One unit is equivalent to 8 grams (g) of alcohol:
a half-pint (approximately 240 milliliter [ml]) of beer, 1 glass (125 ml) of wine or 1
(25 ml) measure of spirits.
- Current smokers or subjects with a history of smoking within 6 months of screening, or
with a total pack year history of >5 pack years. Confirmatory use via a Smokerlyzer is
at the discretion of the local investigator, but is advised if the subject's recent
smoking history is in doubt.
- History of sensitivity to any of the study medications, or components thereof, or a
history of drug or other allergy that, in the opinion of the investigator or Medical
Monitor, contraindicates their participation (e.g. allergy to any previous inhaler
use).
- Participation in another clinical trial, which in the opinion of the investigator,
jeopardizes the subject's safety or study outcomes.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within 56 days.
- The subject has participated in a clinical trial and has received an investigation
product within the following time period prior to the first dosing day in the current
study: 30 days or twice the duration of the biological effect of the investigational
product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
Group 2 Only:
- Presence of hepatitis B surface antigen or positive hepatitis C antibody test result.
- A positive Human Immunodeficiency Virus (HIV) antibody test.
- A positive pre-study drugs of abuse test (not explained by diet or approved
concomitant medications).
- A positive alcohol breath test.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/03/2019
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Sample size
Target
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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0
GSK Investigational Site - Clayton
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Recruitment postcode(s) [1]
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0
3168 - Clayton
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Recruitment outside Australia
Country [1]
0
0
United Kingdom
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State/province [1]
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0
Cambridgeshire
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Country [2]
0
0
United Kingdom
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State/province [2]
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Cambridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
0
0
InVentiv Clinique
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Other
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Name [2]
0
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Monash University
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Address [2]
0
0
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Country [2]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of
reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study
is being conducted to further assess safety and tolerability of inhaled oxytocin, and to
characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered
as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant
women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active
management of the third stage of labour (after the baby is born). Group 2 will enroll
non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous
(IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the
safety and tolerability of IH and IV oxytocin.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02999100
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02999100
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