Oxytocin for Hypermobile Ehlers-Danlos Syndrome

What Was Tested

This registered phase 1, phase 2 trial tested Oxytocin.

The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome.

It had 1 arm (groups): Placebo-Oxytocin sequence (experimental).

The registry classes the interventions as drug and other.

More on the Plan

This will be a single-site study to evaluate the effect of IV oxytocin on chronic pain in female adult patients with hypermobile EDS.

Oxytocin secretion in the body is dynamic and can be affected by multiple factors including the menstrual period.

In order to have minimum variation between tested individuals the researchers conduct this study in females at the same stage of their menstrual cycles.

Hypermobile EDS is more prevalent in females and the symptoms are usually more severe in females and more females come to medical attention.

Who Took Part

The registry lists 2 actual participants took part.

It was open to women only aged from 18 years up to 64 years.

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

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-05-13 with completion listed for 2025-03-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Participant's Subjective Reported Chronic Pain. Change Between Pre and Post Treatment Pain Scores Using the McGill Pain Questionnaire. Change in Participant's Subjective Reported Pain.

It also tracked 3 secondary outcomes, for example Change Between Pre and Post Treatment Anxiety Scores Using the Hospital Anxiety and Depression Scale Questionnaire, Change Between Pre and Post Treatment Depression Scores Using the Hospital Anxiety and Depression Scale Questionnaire and Change Between Pre and Post Treatment Anxiety Scores Using the "State" Part of the State-Trait Anxiety Inventory (STAI) Questionnaire.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Oxytocin in 2 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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