Oxytocin Pharmacokinetics and Pharmacodynamics

Plain-language guide to NCT05488457: phase 2 interventional trial of Oxytocin, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05488457
Phase: phase 2
Status: recruiting participants
Start: 2025-01-01
Completion (planned or actual): 2026-12-30
Participants: 100 (estimated)
Design: na, open label (everyone knows who gets what), prevention
Conditions studied: Post Partum Hemorrhage; Cesarean Section Complications; Blood Loss
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Oxytocin.

This two-part study will measure the action of oxytocin at cesarean delivery.

It had 1 arm (groups): Oxytocin PK/PD Arm (experimental).

The registry classes the interventions as drug.

More on the Plan

Methods: All subjects will receive standard pre-, intra- and postoperative care for their cesarean delivery with additional study interventions.

Study subjects will have an additional intravenous (IV) catheter inserted for intra-operative study-related blood draws.

IV samples will be drawn from the study IV at 0, 1, 2.5, 5, 10, 20, 30, 45, 60 minutes following administration of the study drug.

Who Took Part

100 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18-50 years old. Term (\>39 weeks gestation or 37-39 weeks gestation with fetal or maternal medical indication for delivery) pregnancy. Non-emergent (scheduled or unscheduled) cesarean delivery.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: allergy or contraindication to oxytocin; inability to provide informed consent.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-01-01 with completion listed for 2026-12-30.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Baseline plasma concentrations of deuterated oxytocin (time frame: Intraoperatively (prior to delivery)). Plasma concentrations of deuterated oxytocin at 1 minute (time frame: Intraoperatively (1 minute following study drug administration)). Plasma concentrations of deuterated oxytocin at 2.5 minutes (time frame: Intraoperatively (2.5 minutes following study drug administration)).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Oxytocin in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Oxytocin in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.