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AzTrials

EndometriosisPhase 3ELARIS EM-COCNCT04333576

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

A Phase 3 study testing Elagolix and Combined Oral Contraceptive in people with Endometriosis, run by AbbVie at 179 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Endometriosis
What is being tested?
Elagolix and Combined Oral Contraceptive
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
179 sitesin 2 countries
Study dates
10 Aug 2020to Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to 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).

Who cannot join

  • Pregnant or breastfeeding or planning a pregnancy until completion of the study.
  • Surgical history of hysterectomy or bilateral oophorectomy.
  • Participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from Screening.
  • Participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.

Trial locations and contacts

179 sites in 2 countries.

179 sites in 2 countries

United States176 sites

  • Paramount Research Solutions /ID# 218769

    Alpharetta, Georgia, 30005

  • Pinnacle Research Group /ID# 217062

    Anniston, Alabama, 36207

  • Topaz Clinical Research /ID# 218615

    Apopka, Florida, 32703-5835

  • Academia of Women's Health & Endoscopic Surgery /ID# 217260

    Atlanta, Georgia, 30328

  • Gyn & Fertility Specialists /ID# 223015

    Atlanta, Georgia, 30342-1731

  • Atlanta Women's Research Institute /ID# 217303

    Atlanta, Georgia, 30342

  • Rocky Mountain Internal Medicine - Aurora /ID# 245161

    Aurora, Colorado, 80012-4505

  • Ideal Clinical Research Inc. /ID# 218832

    Aventura, Florida, 33180

  • American Health Network of IN, LLC (Avon) /ID# 218023

    Avon, Indiana, 46123-7960

  • Great Lakes Research Group - Bay City /ID# 217099

    Bay City, Michigan, 48706

  • Clinical Inquest Center Ltd /ID# 217961

    Beavercreek, Ohio, 45431-2573

  • ACCEL Research Sites /ID# 218044

    Birmingham, Alabama, 35218

  • Alabama Clinical Therapeutics /ID# 217166

    Birmingham, Alabama, 35235-3430

  • Alabama Clinical Therapeutics /ID# 222301

    Birmingham, Alabama, 35235-3430

  • University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503

    Birmingham, Alabama, 35294-7333

  • Helix Biomedics, LLC /ID# 218649

    Boynton Beach, Florida, 33436-6634

  • Maimonides Medical Center /ID# 248493

    Brooklyn, New York, 11219

  • Investigators Research Group, LLC /ID# 222891

    Brownsburg, Indiana, 46112

  • Invision Health /ID# 218687

    Buffalo, New York, 14221-5771

  • Cooper University Hospital /ID# 227208

    Camden, New Jersey, 08103

  • Neuro-Behavioral Clinical Research, Inc. /ID# 224026

    Canton, Ohio, 44720

  • Duplicate_PMG Research of Charlotte /ID# 217224

    Charlotte, North Carolina, 28209

  • Tyron Medical Partners, PLLC /ID# 245286

    Charlotte, North Carolina, 28211-5055

  • Chattanooga Research and Medicine /ID# 217045

    Chattanooga, Tennessee, 37412-3964

  • Women's Health Care Center Of Chicago /ID# 245164

    Chicago, Illinois, 60639-2103

  • Seven Hills Clinical Research Group /ID# 224941

    Cincinnati, Ohio, 45255

  • Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 217349

    Cincinnati, Ohio, 45267-0585

  • Olympian Clinical Research /ID# 244426

    Clearwater, Florida, 33756

  • Women's Medical Research Group /ID# 218524

    Clearwater, Florida, 33759

  • MetroHealth Medical Center /ID# 224392

    Cleveland, Ohio, 44109

  • Paramount Research Solutions - College Park /ID# 217358

    College Park, Georgia, 30349-3103

  • Vista Clinical Research /ID# 217151

    Columbia, South Carolina, 29201

  • Duplicate_Columbus Regional Research Ins /ID# 217294

    Columbus, Georgia, 31904

  • Midtown OBGYN North /ID# 222300

    Columbus, Georgia, 31909-5715

  • Central Ohio Clinical Research /ID# 217059

    Columbus, Ohio, 43213-3399

  • Clinical Trials Management - Metairie /ID# 217054

    Covington, Louisiana, 70433-4966

  • Clinical Trials Management, LLC - Covington /ID# 217291

    Covington, Louisiana, 70433

  • DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095

    Dallas, Texas, 75230

  • Cedar Health Research /ID# 224407

    Dallas, Texas, 75251-2202

  • Duplicate_The University of Texas Southwestern Medical Center /ID# 217048

    Dallas, Texas, 75390-8575

  • Velocity Clinical Research - Denver /ID# 217297

    Denver, Colorado, 80209-3804

  • Wayne State University, C.S. Mott Center /ID# 248422

    Detroit, Michigan, 48201-1406

  • Doral Medical Research, LLC /ID# 225146

    Doral, Florida, 33166-6658

  • Universal Axon Clinical Research /ID# 248553

    Doral, Florida, 33166

  • Trinity Research Group /ID# 246932

    Dothan, Alabama, 36301

  • Corner Canyon Obstetrics and G /ID# 217289

    Draper, Utah, 84020

  • Carolina Women's Research and Wellness Center /ID# 217133

    Durham, North Carolina, 27713

  • Widewaters Gynecology /ID# 225621

    East Syracuse, New York, 13057-3072

  • Diagnamics Inc. /ID# 225385

    Encinitas, California, 92024

  • HWC Women's Research Center /ID# 246619

    Englewood, Ohio, 45322

  • Horizon Research Group /ID# 217100

    Eunice, Louisiana, 70535

  • Wright State Physicians Health Center /ID# 217272

    Fairborn, Ohio, 45324

  • Southern Women's Specialists PC /ID# 217143

    Fairhope, Alabama, 36532-3029

  • NECCR Fall River LLC /ID# 217108

    Fall River, Massachusetts, 02720-2972

  • Exordia Medical Research, Inc /ID# 217116

    Fall River, Massachusetts, 02723

  • KO Clinical Research, LLC /ID# 217173

    Fort Lauderdale, Florida, 33316

  • Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061

    Fort Myers, Florida, 33912

  • Women's Health Advantage /ID# 246580

    Fort Wayne, Indiana, 46825

  • Signature Gyn Services /ID# 217299

    Fort Worth, Texas, 76104

  • Grube Gynecology /ID# 245132

    Frackville, Pennsylvania, 17931-2105

  • SBL Special Services LLC /ID# 224899

    Frederick, Maryland, 21702-4301

  • Progressive Women's Health /ID# 248402

    Friendswood, Texas, 77546-3988

  • Willowbend Health and Wellness - Frisco /ID# 217354

    Frisco, Texas, 75035

  • FMC Science, LLC - OB/GYN - Georgetown /ID# 218654

    Georgetown, Texas, 78626-8185

  • North Valley Women's Care /ID# 217092

    Glendale, Arizona, 85308

  • Boeson Research - Grand Junction /ID# 248580

    Grand Junction, Colorado, 81505-1018

  • Boeson Research - Great Falls /ID# 248560

    Great Falls, Montana, 59405-5315

  • University Medical Group /ID# 217355

    Greenville, South Carolina, 29605

  • Vitalink Research - Greenville /ID# 217075

    Greenville, South Carolina, 29615

  • Advanced Women's Health Institute /ID# 217150

    Greenwood Village, Colorado, 80111

  • Penn State University and Milton S. Hershey Medical Center /ID# 217057

    Hershey, Pennsylvania, 17033-2360

  • UTHealth Women's Research Program - Memorial City /ID# 217362

    Houston, Texas, 77024

  • OBGYN Medical Center Associates - Medical Center Office /ID# 245346

    Houston, Texas, 77054-2934

  • Centex Studies, Inc. - Houston /ID# 217357

    Houston, Texas, 77058

  • Leavitt Womens Healthcare /ID# 217118

    Idaho Falls, Idaho, 83404

  • Womens Healthcare Assoc, DBA /ID# 222153

    Idaho Falls, Idaho, 83404

  • University of Iowa Hospitals and Clinics /ID# 217144

    Iowa City, Iowa, 52242

  • Solutions Through Adv Rch /ID# 220973

    Jacksonville, Florida, 32256

  • Care Partners Clinical Research /ID# 217042

    Jacksonville, Florida, 32277

  • Vida Clinical Research /ID# 245325

    Kissimmee, Florida, 34741-2358

  • Kissimmee Clinical Research /ID# 224749

    Kissimmee, Florida, 34741

  • Atella Clinical Research /ID# 224024

    La Palma, California, 90623

  • Red Rocks OB/GYN /ID# 217103

    Lakewood, Colorado, 80228-1810

  • FMC Science /ID# 217047

    Lampasas, Texas, 76550

  • Private practice: Dr. Rex G. Mabey JR /ID# 217134

    Las Vegas, Nevada, 89128

  • Maximos OB/GYN /ID# 229385

    League City, Texas, 77573-2681

  • Womens Clinic of Lincoln, P.C. /ID# 217136

    Lincoln, Nebraska, 68510

  • Applied Research Center of Arkansas /ID# 248494

    Little Rock, Arkansas, 72212-4187

  • South Florida Wellness & Clinic /ID# 222897

    Margate, Florida, 33063

  • Marion Ob/Gyn Inc. /ID# 244175

    Marion, Ohio, 43302-6318

  • Praetorian Pharmaceutical Research /ID# 217159

    Marrero, Louisiana, 70072

  • Univ Hosp Landerbrook /ID# 217065

    Mayfield Heights, Ohio, 44124

  • Research Memphis Associates, LLC /ID# 218022

    Memphis, Tennessee, 38119-3895

  • Sonora Clinical Research /ID# 222147

    Meridian, Idaho, 83646-1144

  • Southern Clinical Research A /ID# 218028

    Metairie, Louisiana, 70001

  • GRE Clinical Research, LLC /ID# 246579

    Miami, Florida, 33145-2457

  • Gold Coast Health Research, LLC /ID# 248624

    Miami, Florida, 33155-1402

  • Admed Research LLC /ID# 227679

    Miami, Florida, 33173

  • The Miami Research Group Inc /ID# 246578

    Miami, Florida, 33174

  • Innova Pharma Research /ID# 245354

    Miami, Florida, 33175-8802

  • Ocean Blue Medical Research Center, Inc /ID# 217286

    Miami Springs, Florida, 33166

  • Salom Tangir, LLC /ID# 217273

    Miramar, Florida, 33027

  • Boeson Research - Missoula /ID# 248559

    Missoula, Montana, 59804-7419

  • Women's Health Alliance of Mobile /ID# 222591

    Mobile, Alabama, 36604-1410

  • Mobile, OBGYN P.C. /ID# 217135

    Mobile, Alabama, 36608

  • Asr, Llc /Id# 217094

    Nampa, Idaho, 83687

  • Access Clinical Trials, Inc. /ID# 217055

    Nashville, Tennessee, 37203

  • Jersey Shore University Medical Center /ID# 217138

    Neptune City, New Jersey, 07753-4859

  • Eastern Carolina Women's Centr /ID# 222358

    New Bern, North Carolina, 28562

  • Rutgers Robert Wood Johnson /ID# 246933

    New Brunswick, New Jersey, 08901

  • Suncoast Clinical Research Pasco County /ID# 217249

    New Port Richey, Florida, 34652

  • Advanced Research Institute, Inc /ID# 217206

    New Port Richey, Florida, 34653

  • Parkmed NYC /ID# 224333

    New York, New York, 10017-4709

  • Columbia Univ Medical Center /ID# 217113

    New York, New York, 10032-3725

  • New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329

    New York, New York, 10065

  • Reproductive Assoc of Delaware /ID# 227764

    Newark, Delaware, 19713

  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063

    Newport News, Virginia, 23606

  • Clinical Research Partners /ID# 217359

    North Chesterfield, Virginia, 23235

  • Dr. Nader and Associates M.D. P.C. /ID# 223571

    North Las Vegas, Nevada, 89030-7187

  • Segal Institute for Clinical Research /ID# 221518

    North Miami, Florida, 33161-5821

  • Valley Renal Medical Group Research /ID# 228614

    Northridge, California, 91324-4622

  • Futura Research, Org /ID# 217361

    Norwalk, California, 90650

  • Alliance for Multispecialty Research, LLC /ID# 217226

    Oak Brook, Illinois, 60523

  • A Premier Medical Research of FL /ID# 216908

    Orange City, Florida, 32763-2833

  • Osceola Gynecology, LLC - Orlando /ID# 227194

    Orlando, Florida, 32806-5412

  • Omega Research Group /ID# 216907

    Orlando, Florida, 32808

  • Clinical Associates of Orlando /ID# 218114

    Orlando, Florida, 32819-8900

  • Duplicate_Suncoast Clinical Research - Palm Harbor /ID# 219133

    Palm Harbor, Florida, 34684

  • The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372

    Park Ridge, Illinois, 60068

  • Advances in Health, Inc. /ID# 217220

    Pearland, Texas, 77854

  • Royal Research,Corp /ID# 221356

    Pembroke Pines, Florida, 33027-1003

  • University of Pennsylvania /ID# 217243

    Philadelphia, Pennsylvania, 19104-5502

  • MomDoc Womens Health Research /ID# 221661

    Phoenix, Arizona, 85251

  • Duplicate_Physicians Research Options /ID# 217302

    Pleasant Grove, Utah, 84062

  • Virginia Women's Health Associates /ID# 227677

    Reston, Virginia, 20190-3215

  • Clinical Trials Virginia, Inc. /ID# 217222

    Richmond, Virginia, 23225

  • Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149

    Richmond, Virginia, 23226-3786

  • Congressional OBGYN /ID# 245349

    Rockville, Maryland, 20850-8726

  • Northern California Research /ID# 217301

    Sacramento, California, 95821-2640

  • Saginaw Valley Med Res Group /ID# 217296

    Saginaw, Michigan, 48604

  • Highland Clinical Research /ID# 224052

    Salt Lake City, Utah, 84124

  • Clinical Trials of Texas, Inc /ID# 217039

    San Antonio, Texas, 78229

  • VIP Trials /ID# 217261

    San Antonio, Texas, 78230

  • Discovery Clinical Trials-San Antonio /ID# 218547

    San Antonio, Texas, 78258

  • A & B Clinical Research /ID# 224471

    San Diego, California, 92103-3363

  • Advanced Clinical Research Center, LLC /ID# 248398

    San Diego, California, 92119-3434

  • Physician Care Clin. Res., LLC /ID# 217264

    Sarasota, Florida, 34239

  • Unity Health- Searcy Medical Center /ID# 217050

    Searcy, Arkansas, 72143-4802

  • Seattle Clinical Research Center /ID# 217117

    Seattle, Washington, 98105

  • GTC Research /ID# 217051

    Shawnee Mission, Kansas, 66218

  • Women's Health Clinic /ID# 217205

    Shreveport, Louisiana, 71118-3133

  • Innovative Women's HealthCare Solutions - Smyrna /ID# 223692

    Smyrna, Georgia, 30082-5166

  • Journey Medical Research Institute - Snellville /ID# 229774

    Snellville, Georgia, 30078-6191

  • North Spokane Women's Health /ID# 217356

    Spokane, Washington, 99207

  • Center for Reproductive Medicine and Robotic Surgery /ID# 223494

    St Louis, Missouri, 63141

  • Richmond OB/GYN Associates PC /ID# 224833

    Staten Island, New York, 10306

  • Duplicate_Palmetto Clinical Research /ID# 217069

    Summerville, South Carolina, 29485-7539

  • Tampa General Hospital - Tampa - General Circle /ID# 217146

    Tampa, Florida, 33606

  • GCP Clinical Research, LLC /ID# 217232

    Tampa, Florida, 33609-4044

  • AC Clinical Research /ID# 227356

    Tiffin, Ohio, 44883

  • Continental Clinical Solutions /ID# 217053

    Towson, Maryland, 21204

  • Tidewater Clinical Research /ID# 217152

    Virginia Beach, Virginia, 23456

  • Medstar Health Research Institute /ID# 244937

    Washington D.C., District of Columbia, 20010

  • James A. Simon, MD, PC /ID# 218116

    Washington D.C., District of Columbia, 20036

  • Center of Reproductive Medicine /ID# 217241

    Webster, Texas, 77598

  • Virtus Research Consultants, LLC /ID# 217052

    Wellington, Florida, 33414

  • Biocentric Healthcare Research /ID# 248582

    West Columbia, South Carolina, 29169-3612

  • The Iowa Clinic, PC /ID# 217351

    West Des Moines, Iowa, 50266-8216

  • Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040

    Wichita, Kansas, 67205-1138

  • Cypress Medical Research Ctr /ID# 217093

    Wichita, Kansas, 67226

  • Accellacare Wilmington /ID# 217097

    Wilmington, North Carolina, 28401

  • Carolina Medical Trials - Winston-Salem /ID# 223002

    Winston-Salem, North Carolina, 27103-4109

  • Unified Women's Clinical Research /ID# 217132

    Winston-Salem, North Carolina, 27103

  • Unified Women's Clinical Research /ID# 218339

    Winston-Salem, North Carolina, 27103

  • Florida Premier Research Institute, LLC /ID# 224499

    Winter Park, Florida, 32789-4681

  • reading Hospital /ID# 223599

    Wyomissing, Pennsylvania, 19611

Other trials in United States

Puerto Rico3 sites

  • Advanced Medical Concepts. PSC /ID# 221337

    Cidra, 00739

  • Henry A. Rodriguez Ginorio, MD /ID# 217233

    San Juan, 00917-5022

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain.

Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico.

Read more

Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18.

There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions
Endometriosis
Being tested
Elagolix, Placebo, Combined Oral Contraceptive
Keywords
Endometriosis, Elagolix, Combined oral contraceptives (COC), Orilissa, Dysmenorrhea
Medical subject headings
Endometriosis, Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElagolixDrug

    Also called ABT-620, Orilissa

    Tablet:Oral

  • PlaceboDrug

    Tablet:Oral

  • Combined Oral ContraceptiveDrug

    Tablet:Oral

Study groups in NCT04333576
Study groupRoleWhat they receive
Double-Blind: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Elagolix; Drug: Placebo; Drug: Combined Oral Contraceptive
Double-Blind: ElagolixExperimentalParticipants 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.
Receives: Drug: Elagolix; Drug: Combined Oral Contraceptive
Double-Blind: Elagolix + COCExperimentalParticipants 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.
Receives: Drug: Elagolix; Drug: Combined Oral Contraceptive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale

    DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.

    Measured: Month 3

  2. Number of Participants Experiencing Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

    Measured: Up to approximately 50 months

Secondary outcomes (1)

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

    NMPP response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start10 Aug 2020
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04333576
Sponsor's protocol ID
M18-969
Acronym
ELARIS EM-COC
Status last verified
Jun 2026
First submitted
2 Apr 2020
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elagolix and Combined Oral Contraceptive in people with Endometriosis, run by AbbVie at 179 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale (time frame: Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04333576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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