Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

What Was Tested

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

It had three arms (groups): Placebo (placebo comparator), Elagolix (experimental) and Elagolix + E2/NETA (experimental).

Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (QD).

The registry classes the interventions as drug.

Who Took Part

378 actual participants took part.

It was open to women only aged from 18 years up to 51 years.

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

Examples of who could join: Subject is a premenopausal female at the time of Screening. Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: subject has history of osteoporosis or other metabolic bone disease.

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 participants stayed in one arm throughout.

Blinding on both sides kept the 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 2016-02-03 with completion listed for 2018-02-14.

It ran at 105 sites in United States (103) and Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants Meeting the Criteria for Responder (time frame: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6).

It also tracked 6 secondary outcomes, for example Change From Baseline in MBL Volume to the Final Month, Percentage of Participants With Suppression of Bleeding at the Final Month, Change From Baseline in MBL Volume to Month 6, Change From Baseline in MBL Volume to Month 3 and Change From Baseline in MBL Volume to Month 1.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 378 people.

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, all human trials.