Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

What Was Tested

This registered phase 3 trial tested Elagolix (non-peptide) for endometriosis.

Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health.

It had three arms (groups): Double-Blind: Placebo (placebo comparator), Double-Blind: Elagolix (experimental) and Double-Blind: Elagolix + COC (experimental).

Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.

Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.

Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 800 planned participants were the target.

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: Documented surgical confirmation of endometriosis and associated moderate to severe pain. Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study. Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs).

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: pregnant or breastfeeding or planning a pregnancy until completion of the study; surgical history of hysterectomy or bilateral oophorectomy; participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The endometriosis participants were allocated by chance, so the Elagolix (non-peptide) group and the comparison group should start out alike.

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

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 2020-08-10 with completion listed for 2027-07.

It ran at 179 sites in United States (176) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale (time frame: Month 3). Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 50 months).

It also tracked 1 secondary outcome, for example Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 800 people with endometriosis.

With 800 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Elagolix (non-peptide) compound page, Endometriosis research.