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Gonadotropin-Releasing Hormone (GnRH) Antagonist

Elagolix + COC for Endometriosis

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale
Secondary outcome measures
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%
0%
Study treatment Arm
Placebo
Elagolix 150 mg

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
~5710

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
501,595 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,309 Total Patients Enrolled

Media Library

Elagolix (Gonadotropin-Releasing Hormone (GnRH) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04333576 — Phase 3
Female Research Study Groups: Double-Blind: Elagolix + COC, Double-Blind: Placebo, Double-Blind: Elagolix
Female Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT04333576 — Phase 3
Elagolix (Gonadotropin-Releasing Hormone (GnRH) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04333576 — Phase 3
Female Patient Testimony for trial: Trial Name: NCT04333576 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there different versions of this research project being conducted in different states?

"There are 100 available for this study including LinQ Research, LLC - Sugarland /ID# 248676 in Pearland, Women's Health Care Center Of Chicago /ID# 245164 in Chicago, and Cypress Medical Research Ctr /ID# 217093 in Wichita,to name a few 100 other locations."

Answered by AI

How can I sign up to be a part of this clinical trial?

"This clinical trial is only seeking patients that have endometrioma and are between 18 and 49 years old. They are looking to enroll around 800 participants."

Answered by AI

Is there any other research like this that has been conducted in the past?

"Elagolix has undergone 8 clinical trials in the last few years, with the first one taking place in 2017. Since then, there have been 18 more trials conducted in 3 different countries."

Answered by AI

Is this research project open to people who are less than 60 years old?

"This study is looking for participants who are between the ages of 18 and 49."

Answered by AI

What other scientific papers have been published that mention Elagolix?

"There are currently 8 ongoing clinical trials studying Elagolix. 4 of those are Phase 3 trials, which are the most advanced. Although the majority of the clinical trials for Elagolix are being conducted in Lone Tree, Colorado, 595 research sites across the world are running trials for this medication."

Answered by AI

How many people fit the profile to take part in this research?

"The sponsor, AbbVie, needs to recruit 800 participants that meet the clinical trial's inclusion criteria from multiple sites including LinQ Research, LLC - Sugarland /ID# 248676 in Pearland, Texas and Women's Health Care Center Of Chicago /ID# 245164 in Chicago, Illinois."

Answered by AI

Are new patients being welcomed into this clinical trial?

"Yes, this is an ongoing clinical trial that is recruiting patients, as noted on the website clinicaltrials.gov. The trial was posted on 8/10/2020, with the most recent update taking place on 11/1/2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Rhode Island
South Carolina
Other
How old are they?
18 - 65
What site did they apply to?
San Francisco Research Institute /ID# 230590
James A. Simon, MD, PC /ID# 218116
Clinical Trials Management
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I got surgery and it came back :(. I just seen it and thought it could help.
PatientReceived 2+ prior treatments
In hopes to find treatment and manage pain. Bc I want to see how I can do better with this treatment.
PatientReceived no prior treatments
Because I have a lot of complications with my female reproductive organs & I am in pain constantly.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Clinical Trials Management: < 48 hours
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04333576.
All > Endometriosis
~110 spots leftby Dec 2024
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