Cardiovascular Disease Risk in Women With Endometriosis

What Was Tested

In this early phase 1 trial, researchers set out to test Elagolix (non-peptide) for endometriosis.

To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

It had two arms (groups): patients without endometriosis (active comparator) and patients with endometriosis (experimental).

Control subjects will be healthy women, with regular menses every 26-34 days. Subjects will be excluded if they have any symptoms of endometriosis, including severe dysmenorrhea or progressive cyclic pelvic pain or prior surgery showing evidence of endometriosis.

Endometriosis will be diagnosed by history of the disease seen at the time of prior surgery or will be diagnosed by classic clinical symptoms of the disease (cyclic progressive pelvic pain) using prior surgical report reviewed by Dr. Taylor.

The registry classes the interventions as drug.

More on the Plan

Their scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) receptor activation.

This cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.

Who Took Part

21 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Young women between the ages of 18 and 45 years (Controls);. Young women between the ages of 18 and 45 years with endometriosis.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: subjects who smoke; subjects who have diabetes,; subjects with sleep apnea or bp\>140/90 will be excluded.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Elagolix (non-peptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Elagolix (non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-07-01 with completion listed for 2025-05-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Flow Mediated Vasodilation (time frame: Baseline and during intervention (1 month)). Microdialysis Perfusions of Acetylcholine ED50 (time frame: Baseline and during intervention (1 month)). Microdialysis Perfusions of Acetylcholine Hill Slope (time frame: baseline and during intervention (1 month)).

It also tracked 3 secondary outcomes, for example Plasma Estrogen Concentration, Serum Concentration Progesterone and Serum Sex Hormone Binding Globulin Concentration.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Elagolix (non-peptide) in 21 people with endometriosis.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Elagolix (non-peptide) compound page, Endometriosis research.