Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women

What Was Tested

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

These symptoms combined are known as vaginal atrophy.

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

It had two arms (groups): Oxytocin, Intravaginal administration (experimental) and Placebo, Intravaginal administration (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 74 planned participants were the target.

It was open to women only aged from 40 years with no upper age limit.

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

Examples of who could join: Signed Informed Consent. At least 40 years of age. Naturally postmenopausal women, completely without menstrual bleedings for at least four years prior to screening. Vaginal pH more than 5.0. BMI at most 29 kg/m2.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to screening; usage of any lubricant for intra-vaginal administration at inclusion; any condition that is a contraindication to treatment with sex steroids.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2010-08 with completion listed for 2011-06.

It ran at 3 sites in Sweden (2) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The Maturation Value (MV) (time frame: 12 weeks of oxytocin treatment as compared to placebo).

It also tracked 9 secondary outcomes, for example Vaginal Atrophy, Quality of Life, The Maturation Value, Vaginal pH, Concentration of Oxytocin in serum and Clinician evaluation of vaginal mucosal appearance.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 74 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.