Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

What Was Tested

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

This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.

It had two arms (groups): Elagolix plus estradiol (E2)/norethindrone acetate (NETA) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

478 participants were randomly assigned at a ratio of 2:1 to the following treatment groups: 1.

Participants entered up to 12 months of PTFU after completing treatment Month 48 (or at any time a participant prematurely discontinued treatment).

Who Took Part

478 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: Participant is a premenopausal female at the time of Screening. Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound \[Transabdominal ultrasound (TAU) or transvaginal ultrasound (TVU)\].

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

How the Study Was Run

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

The 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 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 2017-09-13 with completion listed for 2024-06-28.

It ran at 157 sites in United States (155) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Adverse Events (AEs) (time frame: Baseline to 60 months).

It also tracked 1 secondary outcome, for example Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 478 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.