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Oxytocin Aging Study
Plain-language guide to NCT02069431: phase 1 randomized trial of Oxytocin, 153 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02069431
- Phase
- phase 1
- Status
- terminated early
- Start
- 2016-02
- Completion (planned or actual)
- 2020-05
- Participants
- 153 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Inflammation
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Oxytocin.
It had two arms (groups): Intranasal Oxytocin spray (experimental) and Intranasal Placebo spray (placebo comparator).
Intranasal OT (24 IUs) self-administration will take place twice a day over a 28-day period.
Placebo (containing all of the inert ingredients except for the oxytocin) self-administration will take place twice a day over a 28-day period.
The registry classes the interventions as drug and other.
More on the Plan
The treatment phase will take place in the participant's home.
The participant will be assigned by chance to receive either the oxytocin or the placebo.
The placebo is a substance, like salt water, that looks like and is given in the same way as the oxytocin but contains no oxytocin.
This will not be a clinical doctor visit for routine medical care, but a visit to confirm the participant's eligibility to participate in the study.
Who Took Part
153 actual participants took part.
It was open to people of any sex aged from 55 years up to 100 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Males and females aged 55 years or older. Generally healthy physically and cognitively. Blood pressure \< 180/100 mm Hg. Willing and able to give informed consent.
The full record lists 4 inclusion and 1 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2016-02 with completion listed for 2020-05.
It ran at 2 sites in United States (2).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Oxytocin in 153 people.
It ended early (terminated); 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.