A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain

What Was Tested

This registered phase 3 trial tested Elagolix (non-peptide) for endometriosis.

It had two arms (groups): one (experimental) and Elagolix placebo (placebo comparator).

Participants received elagolix placebo twice a day (BID).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 202 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: Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent. Agree to take only protocol-specified permitted rescue analgesic medications during the screening and treatment Periods.

The full record lists 6 inclusion and 21 exclusion criteria; among the exclusions: previous non-responders to gnrh agonist or gnrh antagonist therapy as judged by the investigator; subjects with a history of hysterectomy, oophorectomy, or surgery affecting drug absorption; or those who plan to undergo the above surgery during the trial;; subjects with undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening;.

How the Study Was Run

The set-up was 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 2023-09-14 with completion listed for 2024-11-22.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of responders of dysmenorrhea (DYS) at week 12 (time frame: 12 weeks). Percentage of responders of Non-Menstrual Pelvic Pain (NMPP) at week 12 (time frame: 12 weeks).

It also tracked 7 secondary outcomes, for example Change from baseline in DYS, Change from baseline in NMPP, Change from baseline in Dyspareunia (DYSP), Change from baseline in Numeric Rating Scale (NRS) scores, Change from baseline in rescue analgesic use and Percentage of participants with a Patient Global Impression of Change (PGIC) response.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 202 people with endometriosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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