Role of Topical Oxytocin Gel in Post-Menopausal Women

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had two arms (groups): Group A (active comparator) and Group B (placebo comparator).

Patients were treated with an active gel containing oxytocin.

Patients were treated with placebo gel without oxytocin.

The registry classes the interventions as other.

Who Took Part

50 actual participants took part.

It was open to women only aged from 47 years up to 66 years.

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

Examples of who could join: The women were post-menopausal and were between 47 and 67 years old. The women's last menstruation had occurred more than one year prior to the study. The women had an established vaginal atrophy. The women scored \< 26 in the Female Sexual Function Index (FSFI). The women had an active sexual relationship.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: women who smoked; women who used hormone replacement therapy; women using a vaginal lubricant.

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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2020-12-01 with completion listed for 2021-05-31.

It ran at 1 site in Egypt.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): vaginal pallor (time frame: by the end of 14 successive days of regular use). intravaginal potential of hydrogen (pH) (time frame: by the end of 14 successive days of regular use). Cytological examination of vaginal smear (time frame: by the end of 14 successive days of regular use).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 50 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.