Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women 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): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

Who Took Part

The registry lists 496 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Subject has completed the 6-Month Treatment Period in pivotal study M12-671. Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: bone mineral density (bmd) loss greater than or equal to 8 percent in the spine, femoral neck or total hip; plans to become pregnant in the next 18 months.

How the Study Was Run

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

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

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

Blinding on both sides kept the endometriosis participants and researchers unaware of who received Elagolix (non-peptide).

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

It started in 2014-05-27 with completion listed for 2016-06-22.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment. Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment.

It also tracked 16 secondary outcomes, for example Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment, Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment, Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment, Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment, Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment and Percent Change From Baseline in Dyspareunia Based on Daily Assessment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 496 people with endometriosis.

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.