The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy

What Was Tested

This registered phase 3 trial tested Oxytocin.

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

The placebo gel will match the IP gel (Hypromellose) with a pH of 3.8, without oxytocin.

The registry classes the interventions as drug and other.

More on the Plan

This study shall include 242 subjects.

Who Took Part

244 planned participants were the target.

It was open to women only aged from 47 years up to 65 years.

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

Examples of who could join: Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: previous treatment with other local non-hormonal moisturizers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion; women taking systemic hormone replacement or pills within the last 6 months; current or history of endometrial hyperplasia or uterine/endometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding.

How the Study Was Run

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

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 2024-09 with completion listed for 2025-06.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The mean change from the baseline to Day 60 of the severity of the Most Bothersome Symptom (MBS) self-assessment (time frame: 60 days). The mean change from the baseline to Day 60 of the vaginal pH (time frame: 60 days). The mean change from the baseline to Day 60 of the Vaginal Maturation Index (VMI) (time frame: 60 days).

It also tracked 12 secondary outcomes, for example The mean changes in MBS severity, pH, and VMI from the baseline to Days 30 and 75, The percentage of subjects identified as Responders on days 60 and 75, The mean change from the baseline to Days 30, 60, and 75 of the physical examination of the vulva and vagina, The mean changes from the baseline to Days 30, 60, and 75 in Vaginal Wall Thickness as measured by transvaginal ultrasound, The mean changes from the baseline to Days 30, 60, and 75 in Doppler indices measured by transvaginal ultrasound and The mean change from the baseline to Days 60 and 75 in selected items from the Female Sexual Function Index (FSFI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 244 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.