Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

A comparison of plasma levels of oxytocin when the IMP is administered by 2 different applicators will be investigated in a sub-group of patients.

In the main part, 160 subjects are enrolled and randomized to 2 different groups; 80 subjects receiving IMP and 80 subjects receiving placebo, in glass syringes.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 202 actual participants took part.

It was open to women only aged from 40 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Females aged 40-65 years at the time of screening, who are willing to participate in the study as indicated by signing the informed consent. Postmenopausal women with at least 24 months of spontaneous amenorrhea, or women who have had surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks ago. Have a vaginal pH \> 5.0 at screening. Have a body mass index (BMI) ≤32 kg/m2. Have an endometrial thickness of \<4 mm as determined by vaginal ultrasonography, in women with an intact uterus.

The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: currently hospitalized; have a history of endometrial hyperplasia or uterine/endometrial, breast or ovarian cancer; have a history of undiagnosed vaginal bleeding.

How the Study Was Run

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

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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2016-05-03 with completion listed for 2017-05-03.

It ran at 3 sites in Sweden (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in severity of the most bothersome VVA symptom (time frame: Baseline and after 12 weeks of treatment).

It also tracked 13 secondary outcomes, for example Change in vaginal pH, Change in % superficial cells, Change in maturation value, Change in summary score for the vulvovaginal atrophy symptoms, Change in severity of the most bothersome VVA symptom and Change in % superficial cells.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 202 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.