Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

What Was Tested

This registered phase 2 trial tested Elagolix (non-peptide).

It had eight arms (groups): Cohort 1: Placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and Cohort 2: Placebo (placebo comparator).

Placebo for elagolix and placebo for E2/NETA twice daily (BID).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 571 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 pre-menopausal female 18 to 51 years of age at Screening. Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: subject has a history of osteoporosis or other metabolic bone disease.

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.

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 2013-04-08 with completion listed for 2015-06.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 18 secondary outcomes, for example Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment, Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment, Mean Change in the Number of Bleeding Days From Baseline to Month 6, Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6, Change in Bleeding Severity Scores From Baseline at the Final Month and Mean Change in Hemoglobin Concentration From Baseline to Final Visit.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Elagolix (non-peptide) in 571 people.

With 571 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, all human trials.