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

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

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.

It had three arms (groups): Group 1 -IH oxytocin (experimental), Group 1 -IM oxytocin (experimental) and Group 2 (IH and IV oxytocin) (experimental).

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 31 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 3 inclusion and 37 exclusion criteria; among the exclusions: adequate peripheral venous access for cannulation; currently pregnant, with an uncomplicated pregnancy as determined by the investigator or designee; estimated date of delivery within 24 weeks of screening.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2016-11-23 with completion listed for 2019-03-01.

It ran at 3 sites in United Kingdom (2) and Australia (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Part 1: Plasma Concentration Time Profile of Oxytocin. Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin. Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin.

It also tracked 10 secondary outcomes, for example Part 1: Number of Participants With Non-SAEs and SAEs, Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1: Absolute Values of Heart Rate, Part 1: Absolute Values of Respiration Rate, Part 1: Absolute Values of Temperature and Part 1: Change From Baseline in SBP and DBP.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 31 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.