Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman

What Was Tested

The trial (phase 2, phase 3) is built around Oxytocin.

Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it.

It had two arms (groups): Oxytocin gel (experimental) and Placebo gel (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Random and conducted on 56 postmenopausal women who meet the inclusion criteria and excluded participants that have exclusion criteria.

All women provided written informed consent before data collection. 1. st Visit: The vagina was assessed regarding infection and any abnormal discharge.

The subjective symptoms were assessed by The most bothersome score.

The vaginal pH was tested with a Nitrazine paper.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to women only aged from 50 years up to 70 years.

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

Examples of who could join: Thai menopausal women aged between 50-70 years who visit Rajavithi gynecology OPD with informed consent with good communication in the Thai language.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: have acute vulvovaginitis (vaginal swab for wet smear and koh); patients who have used hormonal replacement therapy within 12 months; patients with a history of smoking.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-11-30 with completion listed for 2023-07-31.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Comparison of vaginal cytology test for vaginal maturation index measurement (time frame: Change from baseline VMI at 8 weeks).

It also tracked 6 secondary outcomes, for example Comparison of subjective symptoms by The most bothersome symptoms score, Comparison of subjective symptoms by The most bothersome symptoms score, Comparison of subjective symptoms by The most bothersome symptoms score, Comparison of vaginal pH between two group and Comparison of adverse events between two group.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 6 people.

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

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.