An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

What Was Tested

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

It had two arms (groups): Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA) (experimental) and Elagolix (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 433 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: Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: participant met criteria for removal from therapy in her respective pivotal study; participant is planning a pregnancy within the next 18 months; participant has current suicidal markers as noted at the month 6 visit of her respective pivotal study.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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 2016-09-14 with completion listed for 2018-05-07.

It ran at 124 sites in United States (121), Puerto Rico (2) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Participants Meeting the Criteria for Responder (time frame: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)).

It also tracked 4 secondary outcomes, for example Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period, Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period and Percentage of Participants With Suppression of Bleeding at the Final Month.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 433 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.