An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

What Was Tested

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

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 155 actual participants took part.

It was open to women only aged from 18 years up to 49 years.

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

Examples of who could join: Be female, aged 18 to 49 years, inclusive. Have moderate to severe pelvic pain due to endometriosis. Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms. Have regular menstrual cycle. Have a body mass index (BMI) of 18 to 36 kg/m², inclusive.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: are currently receiving gonadotropin-releasing hormone (gnrh) agonist or gnrh antagonist or have received any of these agents within 6 months of the start of screening; are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month; have had surgery for endometriosis within the last month.

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.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Blinding on both sides kept the endometriosis 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 2008-02-19 with completion listed for 2009-04-20.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12 (time frame: Baseline and week 12).

It also tracked 25 secondary outcomes, for example Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain, Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain, Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score, Change From Baseline in the Monthly Mean Dysmenorrhea Score, Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores and Percentage of Days With No Pain Based on NRS.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Elagolix (non-peptide) in 155 people with endometriosis.

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, Endometriosis research.