Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women

PHASE1TerminatedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

November 23, 2016

Primary Completion Date

March 1, 2019

Study Completion Date

March 4, 2019

Conditions
Postpartum Hemorrhage
Interventions
DRUG

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).

DRUG

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

DRUG

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.

DEVICE

ROTAHALER

ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin

Trial Locations (3)

3168

GSK Investigational Site, Clayton

CB2 2GG

GSK Investigational Site, Cambridge

GSK Investigational Site, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

InVentiv Clinique

INDUSTRY

collaborator

Monash University

OTHER

lead

GlaxoSmithKline

INDUSTRY

NCT02999100 - Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women | Biotech Hunter | Biotech Hunter