AzTrials
AzTrials

EndometriosisPhase 3NCT03213457

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

A Phase 3 study testing Estradiol/Norethindrone Acetate and Elagolix in people with Endometriosis, run by AbbVie at 197 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy. 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?
Estradiol/Norethindrone Acetate and Elagolix
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
681 participants
Where
197 sitesin 3 countries
Study dates
7 Jul 2017to 6 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.
  • Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization within 10 years prior to entry into Washout or Screening.
  • Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
  • Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1:
  • At least 2 days of "moderate" or "severe" dysmenorrhea (DYS) AND either
  • At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (NMPP) and an average NMPP score of at least 1.0, OR
  • At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.

Who cannot join

  • Participant has chronic pelvic pain that is not caused by endometriosis, that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-related pain.
  • Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed.
  • Participant has a history of any major depression or post-traumatic stress disorder (PTSD) within 2 years of the screening visit or other major psychiatric disorder at any time.
  • Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the last 1 year at Screening or prior to randomization on Day 1.
  • Participant has any history of osteoporosis or other metabolic bone disease or any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (DXA) measurements
  • Screening DXA results of the lumbar spine (L1-L4), femoral neck or total hip bone mineral density (BMD) corresponding to less than 2.0 or more standard deviations below normal.
Show all 11Show fewer
  • Participant has either:
  • a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension), that has not been stabilized 30 days prior to randomization on Day 1 OR
  • a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR
  • an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the Investigator, (including, but not limited to, uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
  • Participant has any conditions contraindicated with use of E2/NETA.

Trial locations and contacts

197 sites in 3 countries.

197 sites in 3 countries

United States188 sites

  • Albuquerque Clinical Trials, Inc /ID# 154747

    Albuquerque, New Mexico, 87102

  • Bosque Women's Care /ID# 147084

    Albuquerque, New Mexico, 87109

  • Paramount Research Solutions /ID# 145226

    Alpharetta, Georgia, 30005

  • Paramount Research Solutions /ID# 149320

    Alpharetta, Georgia, 30005

  • ClinSite, LLC /ID# 145314

    Ann Arbor, Michigan, 48105

  • Agile Clinical Research Trials /ID# 145494

    Atlanta, Georgia, 30328-5532

  • Atlanta Women's Research Inst /ID# 145543

    Atlanta, Georgia, 30342

  • Lotus Gynecology /ID# 148479

    Austin, Texas, 78703-1448

  • AA (Austin Area) ObGyn PLLC /ID# 205696

    Austin, Texas, 78758-5653

  • Sirius Clinical Research, LLC /ID# 154749

    Austin, Texas, 78759

  • American Health Network of Ind /ID# 167996

    Avon, Indiana, 46123-7960

  • Univ Maryland School Medicine /ID# 151739

    Baltimore, Maryland, 21201

  • Baltimore Suburban Health /ID# 147164

    Baltimore, Maryland, 21208

  • Eastern Maine Medical Center /ID# 161681

    Bangor, Maine, 04401

  • Great Lakes Research Group, Inc. /ID# 145308

    Bay City, Michigan, 48602

  • Gadolin Research, LLC /ID# 201383

    Beaumont, Texas, 77702-1100

  • Clinical Inquest Center Ltd /ID# 147107

    Beavercreek, Ohio, 45431-2573

  • Center for Assisted Reprod. /ID# 154748

    Bedford, Texas, 76022

  • Central Research Associates /ID# 163087

    Birmingham, Alabama, 35205

  • Alabama Clinical Therapeutics, LLC /ID# 145503

    Birmingham, Alabama, 35235-3430

  • Alabama Clinical Therapeutics, LLC /ID# 151468

    Birmingham, Alabama, 35235-3430

  • Helix Biomedics, LLC /ID# 147108

    Boynton Beach, Florida, 33436-6634

  • Gulf Coast Research Group /ID# 162895

    Brandon, Florida, 33510

  • Holston Medical Group /ID# 145449

    Bristol, Tennessee, 37620-7346

  • SUNY Downstate Medical Center /ID# 148749

    Brooklyn, New York, 11203

  • Main Line Fertility Center /ID# 150099

    Bryn Mawr, Pennsylvania, 19010

  • Core Healthcare Group /ID# 149321

    Cerritos, California, 90703

  • Women's Health Practice, LLC /ID# 145517

    Champaign, Illinois, 61820

  • PMG Research of Charlotte /ID# 145432

    Charlotte, North Carolina, 28209

  • DJL Clinical Research, PLLC /ID# 154679

    Charlotte, North Carolina, 28210-8508

  • Chattanooga Medical Research /ID# 145184

    Chattanooga, Tennessee, 37404

  • WR-ClinSearch /ID# 145205

    Chattanooga, Tennessee, 37421-1605

  • CTI Clinical Research Center /ID# 145428

    Cincinnati, Ohio, 45212

  • The Christ Hospital /ID# 149244

    Cincinnati, Ohio, 45219

  • University of Cincinnati /ID# 145496

    Cincinnati, Ohio, 45267-0585

  • Olympian Clinical Research /ID# 148167

    Clearwater, Florida, 33756

  • Univ Hosp Cleveland /ID# 148741

    Cleveland, Ohio, 44106

  • Apogee Women's Health Inc. /ID# 145149

    College Park, Georgia, 30349

  • Vista Clinical Research /ID# 148767

    Columbia, South Carolina, 29201

  • Columbus Regional Research Ins /ID# 159752

    Columbus, Georgia, 31904

  • The Ohio State University /ID# 145444

    Columbus, Ohio, 43210-1257

  • Aventiv Research, Inc. /ID# 145492

    Columbus, Ohio, 43213

  • Aventiv Research, Inc. /ID# 162896

    Columbus, Ohio, 43213

  • Clinical Trials Management, LLC - Covington /ID# 145220

    Covington, Louisiana, 70433

  • Clinical Trials Management, LLC - Covington /ID# 145520

    Covington, Louisiana, 70433

  • Texas Health Presbyterian Hosp /ID# 150098

    Dallas, Texas, 75231

  • UT Southwestern Medical Center /ID# 145201

    Dallas, Texas, 75390-7208

  • Omega Research Maitland, LLC /ID# 145167

    DeBary, Florida, 32713-2260

  • Downtown Womens Health Care /ID# 147955

    Denver, Colorado, 80209

  • Corner Canyon Obstetrics and G /ID# 145519

    Draper, Utah, 84020

  • Carolina Women's Research and Wellness Center /ID# 145356

    Durham, North Carolina, 27713

  • HRC Fertility /ID# 154143

    Encino, California, 91436

  • OB/GYN Associates of Erie /ID# 157935

    Erie, Pennsylvania, 16507-1423

  • Horizon Research Group /ID# 148171

    Eunice, Louisiana, 70535

  • Wright State University & CTRA /ID# 145512

    Fairborn, Ohio, 45324

  • Southern Women's Specialists PC /ID# 148750

    Fairhope, Alabama, 36532-3029

  • NECCR Fall River LLC /ID# 145329

    Fall River, Massachusetts, 02720-2972

  • Genesis Clinical Research - Fall River /ID# 148573

    Fall River, Massachusetts, 02723

  • KO Clinical Research, LLC /ID# 145410

    Fort Lauderdale, Florida, 33316

  • Clinical Physiology Associates /ID# 145237

    Fort Myers, Florida, 33912

  • Women's Health Advantage /ID# 145495

    Fort Wayne, Indiana, 46825

  • Baylor Scott & White /ID# 170430

    Fort Worth, Texas, 76104-4110

  • Signature Gyn Services /ID# 145534

    Fort Worth, Texas, 76104

  • Southampton Women's Health /ID# 151691

    Franklin, Virginia, 23851

  • Willowbend Health and Wellness - Frisco /ID# 145245

    Frisco, Texas, 75035

  • Glendale Adventist Medical Ctr /ID# 160530

    Glendale, California, 91206

  • Unified Women's Clinical Research-Greensboro /ID# 155543

    Greensboro, North Carolina, 27408

  • University Medical Group /ID# 148777

    Greenville, South Carolina, 29605

  • Advanced Women's Health Institute /ID# 145396

    Greenwood Village, Colorado, 80111

  • Penn State University and Milton S. Hershey Medical Center /ID# 145231

    Hershey, Pennsylvania, 17033

  • Pinewest Ob-Gyn, Inc. /ID# 151743

    High Point, North Carolina, 27262

  • Next Innovative Clinical Research /ID# 203863

    Houston, Texas, 77004-6031

  • Advances in Health, Inc. /ID# 145425

    Houston, Texas, 77030

  • Houston Methodist Hospital /ID# 170586

    Houston, Texas, 77030

  • Precision Research Institute - Houston /ID# 154370

    Houston, Texas, 77036

  • The Woman's Hospital of Texas /ID# 145316

    Houston, Texas, 77054

  • Centex Studies, Inc /ID# 148776

    Houston, Texas, 77058-2705

  • HCP Clinical Research LLC /ID# 152045

    Huntington Beach, California, 92646

  • Clinical Research Prime /ID# 161724

    Idaho Falls, Idaho, 83404

  • Womens Healthcare Assoc, DBA /ID# 148744

    Idaho Falls, Idaho, 83404

  • Alliance Research Centers /ID# 151240

    Irvine, California, 92612-1245

  • The Jackson Clinic, PA /ID# 145303

    Jackson, Tennessee, 38305

  • Solutions Through Adv Rch /ID# 148768

    Jacksonville, Florida, 32256

  • Vida Clinical Research /ID# 150282

    Kissimmee, Florida, 34741-2345

  • Red Rocks OB/GYN /ID# 145325

    Lakewood, Colorado, 80228-1810

  • FMC Science /ID# 150981

    Lampasas, Texas, 76550

  • Accent Clinical Trials /ID# 147109

    Las Vegas, Nevada, 89106-4017

  • Office of Edmond E. Pack, MD /ID# 148747

    Las Vegas, Nevada, 89113

  • R. Garn Mabey Jr, MD Chartered /ID# 145361

    Las Vegas, Nevada, 89128

  • Scott Research Inc. /ID# 161704

    Laurelton, New York, 11413

  • Tanner Clinic /ID# 148786

    Layton, Utah, 84041

  • Womens Clinic of Lincoln, P.C. /ID# 145366

    Lincoln, Nebraska, 68510

  • Long Beach Clinical Trial Serv /ID# 152428

    Long Beach, California, 90806

  • Olympia Clinical Trials /ID# 202325

    Los Angeles, California, 90036-4667

  • University of Louisville /ID# 154751

    Louisville, Kentucky, 40202

  • Bluegrass Clinical Research /ID# 151209

    Louisville, Kentucky, 40291-1988

  • Axcess Medical Center /ID# 148169

    Loxahatchee Groves, Florida, 33470

  • Praetorian Pharmaceutical Res /ID# 145405

    Marrero, Louisiana, 70072

  • Research Memphis Associates, LLC /ID# 150100

    Memphis, Tennessee, 38119-3895

  • Advanced Clinical Research /ID# 147086

    Meridian, Idaho, 83642

  • Sonora Clinical Research /ID# 145541

    Meridian, Idaho, 83646-1144

  • Mesa Obstetricians and Gynecologists /ID# 147320

    Mesa, Arizona, 85209

  • Genoma Research Group, Inc /ID# 152558

    Miami, Florida, 33165

  • Vista Health Research LLC - Miami /ID# 151455

    Miami, Florida, 33176-1032

  • Palmetto Professional Research /ID# 153838

    Miami, Florida, 33186-1309

  • Precision Research Organization /ID# 145337

    Miami Lakes, Florida, 33016-1501

  • Ocean Blue Medical Research Center, Inc /ID# 145514

    Miami Springs, Florida, 33166

  • Trinity Health Center Town /ID# 147102

    Minot, North Dakota, 58701

  • Salom Tangir, LLC /ID# 148739

    Miramar, Florida, 33027

  • Women's Health Alliance of Mobile /ID# 150083

    Mobile, Alabama, 36604-1410

  • University of South Alabama /ID# 148774

    Mobile, Alabama, 36604-3302

  • Mobile, Ob-Gyn, P.C. /ID# 145364

    Mobile, Alabama, 36608

  • Venus Gynecology, LLC /ID# 145336

    Myrtle Beach, South Carolina, 29572

  • Asr, Llc /Id# 161680

    Nampa, Idaho, 83687

  • Access Clinical Trials, Inc. /ID# 145224

    Nashville, Tennessee, 37203

  • Jersey Shore University Medical Center /ID# 148756

    Neptune City, New Jersey, 07753-4859

  • Eastern Carolina Women's Centr /ID# 145386

    New Bern, North Carolina, 28562

  • Rutgers Robert Wood Johnson /ID# 152858

    New Brunswick, New Jersey, 08901

  • Ochsner Baptist OB/GYN Clinic /ID# 147144

    New Orleans, Louisiana, 70115

  • Women Under Study, LLC /ID# 151216

    New Orleans, Louisiana, 70125-1923

  • Suncoast Clinical Research /ID# 145484

    New Port Richey, Florida, 34652

  • Manhattan Medical Research /ID# 145175

    New York, New York, 10016-6023

  • Columbia Univ Medical Center /ID# 145334

    New York, New York, 10032-3725

  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477

    Newport News, Virginia, 23606

  • James T. Martin, Jr., MD., Obs /ID# 148755

    North Charleston, South Carolina, 29406

  • Clinical Research Partners, LL /ID# 145392

    North Chesterfield, Virginia, 23235-4722

  • Clinical Research Partners, LL /ID# 145416

    North Chesterfield, Virginia, 23235-4722

  • California Medical Research As /ID# 154746

    Northridge, California, 91324

  • Futura Research, Org /ID# 145406

    Norwalk, California, 90650

  • Affinity Clinical Research /ID# 151469

    Oak Brook, Illinois, 60523

  • Hamburg Regional Gynecology Gr /ID# 161705

    Orchard Park, New York, 14127

  • Center for Women's Research, Inc /ID# 145486

    Palos Heights, Illinois, 60463-1440

  • The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459

    Park Ridge, Illinois, 60068

  • Huntington Medical Foundation /ID# 154750

    Pasadena, California, 91105

  • University of Pennsylvania /ID# 145470

    Philadelphia, Pennsylvania, 19104-5502

  • Drexel Univ College of Med /ID# 149789

    Philadelphia, Pennsylvania, 19129

  • Revere Health /ID# 145540

    Pleasant Grove, Utah, 84062

  • Oregon Health and Science University /ID# 155705

    Portland, Oregon, 97239

  • Clinical Research Adv, Inc. /ID# 149257

    Puyallup, Washington, 98372

  • Unified Women's Clinical Resea /ID# 145353

    Raleigh, North Carolina, 27607

  • Clinical Trials Virginia, Inc. /ID# 145430

    Richmond, Virginia, 23225

  • Alliance Womens Health /ID# 148770

    Richmond, Virginia, 23226-1930

  • Northern California Research /ID# 159753

    Sacramento, California, 95821-2640

  • Saginaw Valley Med Res Group /ID# 145527

    Saginaw, Michigan, 48604

  • Oncova Clinical Research, Inc. /ID# 148175

    Saint Cloud, Florida, 34769

  • Prism Research /ID# 159751

    Saint Paul, Minnesota, 55114

  • Clinical Trials of Texas, Inc /ID# 147100

    San Antonio, Texas, 78229

  • VIP Trials /ID# 151745

    San Antonio, Texas, 78230

  • Discovery Clinical Trials-San Antonio /ID# 145363

    San Antonio, Texas, 78258

  • Precision Research Institute - San Diego /ID# 152557

    San Diego, California, 92114-3643

  • MD Strategies Research Centers /ID# 152429

    San Diego, California, 92119

  • Physician Care Clin. Res., LLC /ID# 145511

    Sarasota, Florida, 34239

  • Meridian Clinical Research, LLC /ID# 148176

    Savannah, Georgia, 31406-2675

  • Unity Health- Searcy Medical Center /ID# 203674

    Searcy, Arkansas, 72143-4802

  • Virginia Mason Medical Center /ID# 145387

    Seattle, Washington, 98101

  • Seattle Women's Health, Research, Gynecology /ID# 145341

    Seattle, Washington, 98105

  • Womens & Family Care, LLC dba /ID# 145211

    Shawnee Mission, Kansas, 66218

  • Women's Health Clinic /ID# 155707

    Shreveport, Louisiana, 71118-3133

  • Omni Fertility and Laser Insti /ID# 145532

    Shreveport, Louisiana, 71118

  • Alta California Medical Group /ID# 155706

    Simi Valley, California, 93065

  • Frontier Clinical Research /ID# 162091

    Smithfield, Pennsylvania, 15478

  • Wayne State University Physician Group - Southfield /ID# 145431

    Southfield, Michigan, 48034

  • North Spokane Women's Health /ID# 145382

    Spokane, Washington, 99207

  • Meridien Research - St Petersburg /ID# 145345

    St. Petersburg, Florida, 33709-3113

  • Treasure Coast Research /ID# 148174

    Stuart, Florida, 34996

  • Houston Ctr for Clin Research /ID# 148799

    Sugar Land, Texas, 77479

  • Palmetto Clinical Research /ID# 150992

    Summerville, South Carolina, 29485-7539

  • Atlanta Gynecology Research Institute /ID# 149322

    Suwanee, Georgia, 30024-7159

  • Madigan Army Medical Center /ID# 145186

    Tacoma, Washington, 98431

  • University of South Florida /ID# 145424

    Tampa, Florida, 33612

  • Stedman Clinical Trials /ID# 152554

    Tampa, Florida, 33613

  • The Women's Health Group - Thornton /ID# 203707

    Thornton, Colorado, 80229-4385

  • University of Toledo /ID# 145403

    Toledo, Ohio, 43614

  • St. Joseph's Regional Medical /ID# 157759

    Totowa, New Jersey, 07512

  • Continental Clinical Solutions /ID# 152041

    Towson, Maryland, 21204

  • Arizona Research Assoc /ID# 161703

    Tucson, Arizona, 85712

  • Eclipse Clinical Research /ID# 155600

    Tucson, Arizona, 85745

  • Tidewater Clinical Research /ID# 145397

    Virginia Beach, Virginia, 23456

  • James A. Simon, MD, PC /ID# 145480

    Washington D.C., District of Columbia, 20036

  • Brown Clinic, PLLP /ID# 154372

    Watertown, South Dakota, 57201

  • Center of Reproductive Medicin /ID# 145467

    Webster, Texas, 77598

  • Virtus Research Consultants, LLC /ID# 147101

    Wellington, Florida, 33414

  • The Iowa Clinic /ID# 145409

    West Des Moines, Iowa, 50266

  • Comprehensive Clinical Trials /ID# 145148

    West Palm Beach, Florida, 33409

  • OB.GYN Associates of WNY /ID# 161665

    West Seneca, New York, 14224

  • PRN Professional Research Network of Kansas, LLC /ID# 151463

    Wichita, Kansas, 67205

  • Cypress Medical Research Ctr /ID# 147159

    Wichita, Kansas, 67226

  • PMG Research of Wilmington /ID# 152555

    Wilmington, North Carolina, 28401-6638

Other trials in United States

Canada5 sites

  • Medicor Research Inc /ID# 151453

    Greater Sudbury, Ontario, P3E 5M4

  • The Ottawa Hospital /ID# 148927

    Ottawa, Ontario, K1H 8L6

  • Strand Clinic /ID# 152582

    St. John's, Newfoundland and Labrador, A1A 4Y3

  • Mount Sinai Hosp.-Toronto /ID# 148972

    Toronto, Ontario, M5G 1X5

  • Victory Reproductive Care /ID# 149016

    Windsor, Ontario, N8W 5R7

Other trials in Canada

Puerto Rico4 sites

  • Puerto Rico Medical Research /ID# 152040

    Ponce, 00717

  • Clinical Research Puerto Rico /ID# 149018

    San Juan, 00909

  • Rodriguez-Ginorio, San Juan /ID# 145545

    San Juan, 00917

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain

The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

Conditions
Endometriosis
Being tested
Estradiol/Norethindrone Acetate, Placebo for Elagolix, Elagolix, Placebo for E2/NETA
Keywords
Elagolix, Endometriosis associated pain, Dysmenorrhea (DYS), Non-menstrual pelvic pain (NMPP), ORILISSA
Medical subject headings
Endometriosis, Dysmenorrhea

What participants receive

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

  • Estradiol/Norethindrone AcetateDrug

    Also called Activella, E2/NETA

    Tablets

  • Placebo for ElagolixDrug

    Tablet

  • ElagolixDrug

    Also called ABT-620, Elagolix Sodium, ORILISSA

    Tablet

  • Placebo for E2/NETADrug

    Tablets

Study groups in NCT03213457
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Receives: Drug: Placebo for Elagolix; Drug: Placebo for E2/NETA
Elagolix / Elagolix + E2/NETAExperimentalElagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Receives: Drug: Estradiol/Norethindrone Acetate; Drug: Elagolix
Elagolix + E2/NETAExperimentalElagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Receives: Drug: Estradiol/Norethindrone Acetate; Drug: Elagolix

What is being measured

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

  1. Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment

    Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over 35 days prior to each visit.

    Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic).

    Measured: Month 6, Month 12

  2. Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment

    Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over the 35 days prior to each visit.

    Response was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics).

    Measured: Month 6, Month 12

Secondary outcomes (14)

  1. Change From Baseline in DYS at Month 12 Based on Daily Assessment

    Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores were averaged over the 35 days prior to each visit.

    Measured: Baseline, Month 12

  2. Change From Baseline in DYS at Month 6 Based on Daily Assessment

    Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    0: No discomfort

    1. Mild discomfort but I was easily able to do the things I usually do
    2. Moderate discomfort or pain that made it difficult to do some of the things I usually do
    3. Severe pain that made it difficult to do the things I usually do.

    Pain scores were averaged over the 35 days prior to each visit.

    Measured: Baseline, Month 6

  3. Change From Baseline in DYS at Month 3 Based on Daily Assessment

    Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    0: No discomfort

    1. Mild discomfort but I was easily able to do the things I usually do
    2. Moderate discomfort or pain that made it difficult to do some of the things I usually do
    3. Severe pain that made it difficult to do the things I usually do.

    Pain scores were averaged over the 35 days prior to each visit.

    Measured: Baseline, Month 3

  4. Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment

    Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over the 35 days prior to each visit.

    Measured: Baseline, Month 12

  5. Change From Baseline in NMPP at Month 6 Based on Daily Assessment

    Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over the 35 days prior to each visit.

    Measured: Baseline, Month 6

  6. Change From Baseline in NMPP at Month 3 Based on Daily Assessment

    Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:

    • 0: No discomfort
    • 1: Mild discomfort but I was easily able to do the things I usually do
    • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
    • 3: Severe pain that made it difficult to do the things I usually do.

    Pain scores and analgesic use were averaged over the 35 days prior to each visit.

    Measured: Baseline, Month 3

  7. Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score

    The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.

    Measured: Baseline, Month 6

  8. Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment

    Participants assessed DYSP each day in an e-Diary according to the following response options:

    • 0: None; No discomfort during sexual intercourse
    • 1: Mild; Able to tolerate the discomfort during sexual intercourse
    • 2: Moderate; Intercourse was interrupted due to pain
    • 3: Severe; Avoided intercourse because of pain
    • Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.

    Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

    Measured: Baseline, Month 12

  9. Change From Baseline in DYSP at Month 6 Based on Daily Assessment

    Participants assessed DYSP each day in an e-Diary according to the following response options:

    • 0: None; No discomfort during sexual intercourse
    • 1: Mild; Able to tolerate the discomfort during sexual intercourse
    • 2: Moderate; Intercourse was interrupted due to pain
    • 3: Severe; Avoided intercourse because of pain
    • Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.

    Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

    Measured: Baseline, Month 6

  10. Change From Baseline in DYSP at Month 3 Based on Daily Assessment

    Participants assessed DYSP each day in an e-Diary according to the following response options:

    • 0: None; No discomfort during sexual intercourse
    • 1: Mild; Able to tolerate the discomfort during sexual intercourse
    • 2: Moderate; Intercourse was interrupted due to pain
    • 3: Severe; Avoided intercourse because of pain
    • Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.

    Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

    Measured: Baseline, Month 3

  11. Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score

    The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.

    Measured: Baseline, Month 12

  12. Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)

    The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.

    Measured: Baseline, Month 12

  13. Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS

    The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.

    Measured: Baseline, Month 6

  14. Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS

    The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.

    Measured: Baseline, 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 posted11 Jul 2017
  2. Study start7 Jul 2017
  3. Primary completion27 Mar 2020
  4. Study completion6 Dec 2023

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
681 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03213457
Sponsor's protocol ID
M14-702
Status last verified
Nov 2024
First submitted
7 Jul 2017
Last updated
20 Dec 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Watts NB, Binkley N, Owens CD, Al-Hendy A, Puscheck EE, Shebley M, Schlaff WD, Simon JA. Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life. J Womens Health (Larchmt). 2021 Oct;30(10):1416-1430. doi: 10.1089/jwh.2020.8989. Epub 2021 Aug 25.

    PubMed 34435897

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Estradiol/Norethindrone Acetate and Elagolix in people with Endometriosis, run by AbbVie at 197 sites in 3 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States, Canada, 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?

Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment (time frame: Month 6, Month 12). 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 NCT03213457, which also lists 1 linked publication.

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 20 Dec 2024; AzTrials last refreshed its copy on 3 Nov 2026.

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