Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to 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 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.

All participants who prematurely discontinued treatment (unless pregnant or elected surgery for endometriosis) or completed the 6-month Treatment Period in this extension study were to enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.

Who Took Part

506 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: Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528). 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.

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.

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

Neither the endometriosis participants nor the staff measuring them knew who was on Elagolix (non-peptide), so expectations could not easily colour the readings.

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

It started in 2012-12-28 with completion listed for 2015-05.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 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 506 people with endometriosis.

With 506 participants it is a large trial for this field.

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.