Efficacy and Safety Study of Elagolix in Women With Endometriosis

What Was Tested

In this phase 2 trial, researchers set out to test Elagolix (non-peptide) for endometriosis.

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

The registry classes the interventions as drug.

Who Took Part

137 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 a history of regular menstrual cycles. Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8 years of the start of screening. 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 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; have had a hysterectomy or bilateral oophorectomy.

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.

Neither the endometriosis participants nor the staff measuring them knew who was on Elagolix (non-peptide), so expectations could not easily colour the readings.

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

It started in 2009-10-12 with completion listed for 2010-09-22.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase (time frame: Baseline and Weeks 4 and 8). Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases (time frame: Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment)). Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Double-Blind Treatment Phase (time frame: Baseline and weeks 4 and 8).

It also tracked 20 secondary outcomes, for example Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8, Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8, Percentage of Participants With a Response in Monthly Mean Cumulative Pain Score at Week 8, Percentage of Participants With a Response in Monthly Mean Dyspareunia Score at Week 8, Change From Baseline in the Percentage of Days of Any Analgesic Use During the Double-Blind Treatment Phase and Change From Baseline in the Percentage of Days of Any Analgesic Use During the Open-Label and Posttreatment Phases.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Elagolix (non-peptide) in 137 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.