Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

What Was Tested

The trial (phase 2) is built around Elagolix (non-peptide).

It had ten arms (groups): one (experimental), one (experimental), Cohort 4 Placebo (placebo comparator), one (experimental) and Cohort 1 Placebo (placebo comparator).

Participants received placebo to elagolix BID for 3 months.

The registry classes the interventions as drug.

Who Took Part

The registry lists 271 actual participants took part.

It was open to women only aged from 20 years up to 49 years.

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

Examples of who could join: Subject is a pre-menopausal female 20 to 49 years of age. Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:. Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary). Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements. Subject has a history of regular menstrual cycles between 24 to 35 days.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: subject has a history of osteoporosis or other metabolic bone disease; epilepsy or seizures; type 1 diabetes.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

The Elagolix (non-peptide) group and the comparison group ran side by side rather than switching.

As a double-blind Elagolix (non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-09-08 with completion listed for 2013-11.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL).

It also tracked 19 secondary outcomes, for example Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL), Change in Hemoglobin Concentration From Baseline to Month 3, Change From Baseline to Month 3 in Uterine Bleeding Score, Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding, Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding and Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Elagolix (non-peptide) in 271 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.