A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

What Was Tested

The trial (phase 3) is built around Elagolix (non-peptide) for endometriosis.

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

Placebo twice daily (BID) for the 6-month Treatment Period.

The registry classes the interventions as drug and other.

More on the Plan

An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis.

Pregnancy testing will be performed monthly throughout the study.

Who Took Part

The registry lists 815 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: Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period. Agrees to use required birth control methods during the entire length of participation in the study. Subjects must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening Period, prior to Day 1.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: subject has a history of osteoporosis or other metabolic bone disease; subject has a current history of undiagnosed abnormal uterine bleeding.

How the Study Was Run

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

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

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 2013-09-09 with completion listed for 2016-01-06.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) (time frame: At Month 3 of the Treatment Period). Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) (time frame: At Month 3 of Treatment Period).

It also tracked 29 secondary outcomes, for example Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores, Change From Baseline to Month 6 in DYS, Change From Baseline to Month 6 in NMPP, Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics, Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics and Change From Baseline to Month 3 in Dyspareunia (DYSP).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 815 people with endometriosis.

With 815 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.