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

What Was Tested

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

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

Placebo BID for the 6-month Treatment Period.

The registry classes the interventions as drug.

More on the Plan

Participants will be administered the study drug up to month 6.

Who Took Part

The registry lists 336 planned participants were the target.

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 understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent. Participant is premenopausal female, between 18 and 49 years of age (both inclusive), regular menstruation within 3 months before screening. Participant clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Screening.

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: participant who has a history of sensitivity to elagolix or excipients; participant who blood pregnancy test is positive at screening or on the day of randomization; participant who has a history of drug or alcohol abuse within 6 months of screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Elagolix (non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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 2022-09-04 with completion listed for 2023-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Responders of Dysmenorrhea (DYS) at week 12 (time frame: Week12). Percentage of Responders of Non-Menstrual Pelvic Pain (NMPP) at week 12 (time frame: Week12).

It also tracked 4 secondary outcomes, for example Safety Specifications in the Treatment Period, Change in Numeric Rating Scale (NRS) Scores at week 12, Change in Dysmenorrhea (DYS) Score at week 24 and Change in Non-Menstrual Pelvic Pain (NMPP) Score at week 24.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 336 people with endometriosis.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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