A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

What Was Tested

In this phase 3 trial, researchers set out to test Elagolix (non-peptide) for endometriosis.

It had four arms (groups): Arm A (experimental), Arm C (experimental), Arm D (experimental) and Arm B (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to women only aged from 18 years up to 49 years.

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

Examples of who could join: Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening. Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization or histology within 10 years prior to entry into Washout or Screening,. Participant must agree to use only those rescue analgesics permitted by the protocol during the Screening and Treatment Periods for her endometriosis-associated pain. Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1:. At least 2 days of "moderate" or "severe" DYS, AND either,.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: participant has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-associated pain; participant has any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (dxa) measurements; participant has either.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Elagolix (non-peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

As a double-blind Elagolix (non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-12-27 with completion listed for 2018-10-23.

It ran at 37 sites in United States (37).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of Responders at Month 6 Based on DYS Pain Scale (time frame: Month 6). Proportion of Responders at Month 6 Based on NMPP Pain Scale (time frame: Month 6).

It also tracked 38 secondary outcomes, for example Change From Baseline in DYS at Month 6, Change From Baseline in NMPP at Month 6, Change From Baseline in Dyspareunia at Month 6, Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6, Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 and Proportion of Responders Over Time.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 11 people with endometriosis.

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 Elagolix (non-peptide) compound page, Endometriosis research.