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Does Oxytocin Modulate Rewarding Effects in Women and Fluctuating Across the Menstrual Cycle

Plain-language guide to NCT03144115: early phase 1 randomized trial of Oxytocin, 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03144115
Phase
early phase 1
Status
completed
Start
2016-10
Completion (planned or actual)
2018-06
Participants
80 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (early phase 1) is built around Oxytocin.

The aim of the study is to explore how the rewarding effect of men's verbal compliment is modulated by oxytocin and gonadal hormone in a romantic context.

It had four arms (groups): oxytocin fertility (experimental), placebos fertility (placebo comparator), oxytocin luteal (experimental) and placebos luteal (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The study employs a double-blind, within-subject, placebo-control design.

Women will be administered with the same drug twice (oxytocin or placebo) respectively the fertile and luteal phase followed by a MRI scanning.

Each male face will be paired with two sentences of the same kind.

After the fMRI participants will recall the judgment followed by a memory test during which they have to indicate whether the they have seen the face during scanning (old) or whether it is an unknown face (new).

Who Took Part

80 actual participants took part.

It was open to women only aged from 18 years up to 25 years.

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

Examples of who could join: Single in the past 3 months. Healthy subjects with regular menstrual cycle.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: pregnant, menstruating, taking oral contraceptives; metal implanted, with tatoo, or hair dyed within 6 months; participated in another intranasal experiment within 6 months.

How the Study Was Run

It was run as a randomized, parallel-group and double-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 and investigator.

It started in 2016-10 with completion listed for 2018-06.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Oxytocin effect on neural activity as assessed via fMRI towards reward between fertility and luteal phases (time frame: 45min-120min after treatment).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 80 people.

The trial is marked completed; 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.