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Oxytocin Pharmacokinetics After Intramuscular Injection
Plain-language guide to NCT04427540: phase 2 interventional trial of Oxytocin. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04427540
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2021-12
- Completion (planned or actual)
- 2022-06
- Participants
- n/a (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Osteoarthritis, Knee
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Oxytocin.
In this study people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study.
Study participants will have an intravenous catheter (IV) inserted in the forearm.
It had 1 arm (groups): Oxytocin (experimental).
The registry classes the interventions as drug.
More on the Plan
Participants will come to the Clinical Research Unit (CRU) and have an intravenous catheter (IV) inserted in the forearm.
Who Took Part
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 1\. Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40. 3\. Normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute. 5\. diagnosis of advanced knee arthritis.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: 4\. subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2021-12 with completion listed for 2022-06.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Oxytocin concentration in serum (time frame: 1 minute post administration to 120 minutes post administration).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Oxytocin in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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.
Related Pages
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.