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Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women

Plain-language guide to NCT02229721: phase 2 randomized trial of Oxytocin, sexual function & libido (women and men), 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02229721
Phase
phase 2
Status
completed
Start
2012-06
Completion (planned or actual)
2013-10
Participants
30 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Female Sexual Dysfunction
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 for sexual function & libido (women and men).

It had two arms (groups): one (active comparator) and Placebo Nasalspray (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to women only aged from 40 years up to 70 years.

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

Examples of who could join: Willingness to attempt sexual intercourse and/ or masturbation at least two times per week. Ongoing relationship for at least 3 months. Female subjects aging 40 years and more, Male subjects must be older than 18. The participation in this study should be of free choice to male partners. Willingness to perform a pregnancy test every month (for pre-menopausal subjects).

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: primary sexual dysfunction; sexual abuse; severe psychiatric diseases.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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.

In the crossover set-up each of the sexual function & libido (women and men) participants took both Oxytocin and the comparison in turn, acting as their own control.

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 2012-06 with completion listed for 2013-10.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Female Sexual Function (time frame: 22 weeks).

It also tracked 1 secondary outcome, for example Hamilton Depression Scale (HDS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 30 people with sexual function & libido (women and men).

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Sexual function & libido (women and men) research.

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.