Clinically Meaningful Reduction in Dyspareunia Is Associated With Significant Improvements in Health-Related Quality of Life Among Women With Moderate to Severe Pain Associated With Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix

What Was Tested

This randomized controlled trial paper looks at Elagolix (non-peptide) in the context of endometriosis.

This study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results.

As such, the findings may not be generalizable in a real-world setting.

Who Took Part

The age groups tagged for this paper are teenagers, young adults, adults and middle-aged adults, women only.

How the Study Was Run

In design terms this was a randomized and placebo-controlled study.

The participants were allocated by chance, so the Elagolix (non-peptide) group and the comparison group should start out alike.

A placebo (an inactive look-alike) gave the Elagolix (non-peptide) group a baseline to be compared against.

This was a post hoc analysis of pooled data from the phase III ELARIS-I and ELARIS-II clinical trials.

HRQoL was measured using the validated Endometriosis Health Profile-30 questionnaire (EHP-30), consisting of 5 core domains and a sexual intercourse modular domain.

Dyspareunia was ranked 0-3 (none, mild, moderate, or severe) or not applicable using a daily eDiary and averaged monthly.

What Was Measured

This study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results.

PubMed files the paper under topics including Dyspareunia, Endometriosis, Hydrocarbons, Fluorinated, Pyrimidines and Quality of Life.

The authors tagged it with the keywords Elagolix, Endometriosis Health Profile-30, Gonadotropin-Releasing Hormone Antagonist and Health-Related Quality of Life.

What This Means in Plain Language

The paper is a randomized and placebo-controlled study of Elagolix (non-peptide) in people with endometriosis.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2020 (The journal of sexual medicine), a journal based in Netherlands.

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