An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy

What Was Tested

The trial (phase 2) is built around Oxytocin.

Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner, drier, and less elastic due to lack of estrogen.

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

The registry classes the interventions as drug.

Who Took Part

227 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.

The full record lists 10 inclusion and 14 exclusion criteria; among the exclusions: be 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

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

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

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, care provider, investigator and outcomes assessor.

It started in 2014-10 with completion listed for 2015-07.

It ran at 5 sites in Sweden (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline to Week 12 in severity of vaginal atrophy symptom that has been self-identified by the subject as being the most bothersome to her in the vaginal atrophy questionnaire (time frame: After 12 weeks of treatment).

It also tracked 7 secondary outcomes, for example Change from baseline to Week 12 in Quality of Life evaluation parameters.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 227 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.