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Gonadotropin-Releasing Hormone (GnRH) Antagonist

Elagolix + COC for Endometriosis (ELARIS EM-COC Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are your menstrual cycles regular, meaning every 21-35 days?

Documented surgical confirmation of endometriosis and associated moderate to severe pain.

Must not have

Are you currently breastfeeding, pregnant, or planning a pregnancy.

You have been diagnosed with PCOS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3

Awards & highlights

Pivotal Trial

Summary

This trial will evaluate the efficacy and safety of elagolix in combination with COC compared to placebo in women with endometriosis.

Who is the study for?

This trial is for adult women who have endometriosis with moderate to severe pain and are suitable candidates for combined oral contraceptives (COCs). They must not be pregnant, breastfeeding, or planning pregnancy until the study ends. Participants should not have had a hysterectomy or oophorectomy, osteoporosis, other metabolic bone diseases, or any chronic pain conditions that could affect their pain assessment.

What is being tested?

The study tests how well elagolix works with COCs compared to a placebo in managing painful periods due to endometriosis. About 800 participants will be randomly assigned to one of three groups: two receiving different treatments and one receiving a placebo. After three months on varied regimens, all participants will receive elagolix with COCs from Month 4 through Month 18.

What are the potential side effects?

Potential side effects include those commonly associated with hormonal contraceptives such as nausea, headaches, mood changes, weight gain and breast tenderness. Elagolix may cause liver issues, bone loss over long-term use and hot flashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale

Secondary study objectives

Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale

Side effects data

From 2021 Phase 4 trial • 82 Patients • NCT03886220

13%

HEADACHE

11%

HOT FLUSH

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Elagolix 150 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Double-Blind: Elagolix + COCExperimental Treatment2 Interventions

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.

Group II: Double-Blind: ElagolixExperimental Treatment2 Interventions

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.

Group III: Double-Blind: PlaceboPlacebo Group3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Combined Oral Contraceptive

2010

Completed Phase 4

~680

Elagolix

2019

Completed Phase 4

~6190