A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
NCT ID: NCT03213457
Last Updated: 2024-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
681 participants
INTERVENTIONAL
2017-07-07
2023-12-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo 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.
Placebo for Elagolix
Tablet
Placebo for E2/NETA
Tablets
Elagolix / Elagolix + E2/NETA
Elagolix 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.
Estradiol/Norethindrone Acetate
Tablets
Elagolix
Tablet
Elagolix + E2/NETA
Elagolix 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.
Estradiol/Norethindrone Acetate
Tablets
Elagolix
Tablet
Interventions
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Estradiol/Norethindrone Acetate
Tablets
Placebo for Elagolix
Tablet
Elagolix
Tablet
Placebo for E2/NETA
Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. At least 2 days of "moderate" or "severe" dysmenorrhea (DYS) AND either
2. At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (NMPP) and an average NMPP score of at least 1.0, OR
3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.
Exclusion Criteria
* 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.
* Participant has either:
1. 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
2. a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR
3. 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.
18 Years
49 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Central Research Associates /ID# 163087
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC /ID# 145503
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC /ID# 151468
Birmingham, Alabama, United States
Southern Women's Specialists PC /ID# 148750
Fairhope, Alabama, United States
Women's Health Alliance of Mobile /ID# 150083
Mobile, Alabama, United States
University of South Alabama /ID# 148774
Mobile, Alabama, United States
Mobile, Ob-Gyn, P.C. /ID# 145364
Mobile, Alabama, United States
Mesa Obstetricians and Gynecologists /ID# 147320
Mesa, Arizona, United States
Arizona Research Assoc /ID# 161703
Tucson, Arizona, United States
Eclipse Clinical Research /ID# 155600
Tucson, Arizona, United States
Unity Health- Searcy Medical Center /ID# 203674
Searcy, Arkansas, United States
Core Healthcare Group /ID# 149321
Cerritos, California, United States
HRC Fertility /ID# 154143
Encino, California, United States
Glendale Adventist Medical Ctr /ID# 160530
Glendale, California, United States
HCP Clinical Research LLC /ID# 152045
Huntington Beach, California, United States
Alliance Research Centers /ID# 151240
Irvine, California, United States
Long Beach Clinical Trial Serv /ID# 152428
Long Beach, California, United States
Olympia Clinical Trials /ID# 202325
Los Angeles, California, United States
California Medical Research As /ID# 154746
Northridge, California, United States
Futura Research, Org /ID# 145406
Norwalk, California, United States
Huntington Medical Foundation /ID# 154750
Pasadena, California, United States
Northern California Research /ID# 159753
Sacramento, California, United States
Precision Research Institute - San Diego /ID# 152557
San Diego, California, United States
MD Strategies Research Centers /ID# 152429
San Diego, California, United States
Alta California Medical Group /ID# 155706
Simi Valley, California, United States
Downtown Womens Health Care /ID# 147955
Denver, Colorado, United States
Advanced Women's Health Institute /ID# 145396
Greenwood Village, Colorado, United States
Red Rocks OB/GYN /ID# 145325
Lakewood, Colorado, United States
The Women's Health Group - Thornton /ID# 203707
Thornton, Colorado, United States
James A. Simon, MD, PC /ID# 145480
Washington D.C., District of Columbia, United States
Helix Biomedics, LLC /ID# 147108
Boynton Beach, Florida, United States
Gulf Coast Research Group /ID# 162895
Brandon, Florida, United States
Olympian Clinical Research /ID# 148167
Clearwater, Florida, United States
Omega Research Maitland, LLC /ID# 145167
DeBary, Florida, United States
KO Clinical Research, LLC /ID# 145410
Fort Lauderdale, Florida, United States
Clinical Physiology Associates /ID# 145237
Fort Myers, Florida, United States
Solutions Through Adv Rch /ID# 148768
Jacksonville, Florida, United States
Vida Clinical Research /ID# 150282
Kissimmee, Florida, United States
Axcess Medical Center /ID# 148169
Loxahatchee Groves, Florida, United States
Genoma Research Group, Inc /ID# 152558
Miami, Florida, United States
Vista Health Research LLC - Miami /ID# 151455
Miami, Florida, United States
Palmetto Professional Research /ID# 153838
Miami, Florida, United States
Precision Research Organization /ID# 145337
Miami Lakes, Florida, United States
Ocean Blue Medical Research Center, Inc /ID# 145514
Miami Springs, Florida, United States
Salom Tangir, LLC /ID# 148739
Miramar, Florida, United States
Suncoast Clinical Research /ID# 145484
New Port Richey, Florida, United States
Oncova Clinical Research, Inc. /ID# 148175
Saint Cloud, Florida, United States
Physician Care Clin. Res., LLC /ID# 145511
Sarasota, Florida, United States
Meridien Research - St Petersburg /ID# 145345
St. Petersburg, Florida, United States
Treasure Coast Research /ID# 148174
Stuart, Florida, United States
University of South Florida /ID# 145424
Tampa, Florida, United States
Stedman Clinical Trials /ID# 152554
Tampa, Florida, United States
Virtus Research Consultants, LLC /ID# 147101
Wellington, Florida, United States
Comprehensive Clinical Trials /ID# 145148
West Palm Beach, Florida, United States
Paramount Research Solutions /ID# 145226
Alpharetta, Georgia, United States
Paramount Research Solutions /ID# 149320
Alpharetta, Georgia, United States
Agile Clinical Research Trials /ID# 145494
Atlanta, Georgia, United States
Atlanta Women's Research Inst /ID# 145543
Atlanta, Georgia, United States
Apogee Women's Health Inc. /ID# 145149
College Park, Georgia, United States
Columbus Regional Research Ins /ID# 159752
Columbus, Georgia, United States
Meridian Clinical Research, LLC /ID# 148176
Savannah, Georgia, United States
Atlanta Gynecology Research Institute /ID# 149322
Suwanee, Georgia, United States
Clinical Research Prime /ID# 161724
Idaho Falls, Idaho, United States
Womens Healthcare Assoc, DBA /ID# 148744
Idaho Falls, Idaho, United States
Advanced Clinical Research /ID# 147086
Meridian, Idaho, United States
Sonora Clinical Research /ID# 145541
Meridian, Idaho, United States
Asr, Llc /Id# 161680
Nampa, Idaho, United States
Women's Health Practice, LLC /ID# 145517
Champaign, Illinois, United States
Affinity Clinical Research /ID# 151469
Oak Brook, Illinois, United States
Center for Women's Research, Inc /ID# 145486
Palos Heights, Illinois, United States
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459
Park Ridge, Illinois, United States
American Health Network of Ind /ID# 167996
Avon, Indiana, United States
Women's Health Advantage /ID# 145495
Fort Wayne, Indiana, United States
The Iowa Clinic /ID# 145409
West Des Moines, Iowa, United States
Womens & Family Care, LLC dba /ID# 145211
Shawnee Mission, Kansas, United States
PRN Professional Research Network of Kansas, LLC /ID# 151463
Wichita, Kansas, United States
Cypress Medical Research Ctr /ID# 147159
Wichita, Kansas, United States
University of Louisville /ID# 154751
Louisville, Kentucky, United States
Bluegrass Clinical Research /ID# 151209
Louisville, Kentucky, United States
Clinical Trials Management, LLC - Covington /ID# 145220
Covington, Louisiana, United States
Clinical Trials Management, LLC - Covington /ID# 145520
Covington, Louisiana, United States
Horizon Research Group /ID# 148171
Eunice, Louisiana, United States
Praetorian Pharmaceutical Res /ID# 145405
Marrero, Louisiana, United States
Ochsner Baptist OB/GYN Clinic /ID# 147144
New Orleans, Louisiana, United States
Women Under Study, LLC /ID# 151216
New Orleans, Louisiana, United States
Women's Health Clinic /ID# 155707
Shreveport, Louisiana, United States
Omni Fertility and Laser Insti /ID# 145532
Shreveport, Louisiana, United States
Eastern Maine Medical Center /ID# 161681
Bangor, Maine, United States
Univ Maryland School Medicine /ID# 151739
Baltimore, Maryland, United States
Baltimore Suburban Health /ID# 147164
Baltimore, Maryland, United States
Continental Clinical Solutions /ID# 152041
Towson, Maryland, United States
NECCR Fall River LLC /ID# 145329
Fall River, Massachusetts, United States
Genesis Clinical Research - Fall River /ID# 148573
Fall River, Massachusetts, United States
ClinSite, LLC /ID# 145314
Ann Arbor, Michigan, United States
Great Lakes Research Group, Inc. /ID# 145308
Bay City, Michigan, United States
Saginaw Valley Med Res Group /ID# 145527
Saginaw, Michigan, United States
Wayne State University Physician Group - Southfield /ID# 145431
Southfield, Michigan, United States
Prism Research /ID# 159751
Saint Paul, Minnesota, United States
Womens Clinic of Lincoln, P.C. /ID# 145366
Lincoln, Nebraska, United States
Accent Clinical Trials /ID# 147109
Las Vegas, Nevada, United States
Office of Edmond E. Pack, MD /ID# 148747
Las Vegas, Nevada, United States
R. Garn Mabey Jr, MD Chartered /ID# 145361
Las Vegas, Nevada, United States
Jersey Shore University Medical Center /ID# 148756
Neptune City, New Jersey, United States
Rutgers Robert Wood Johnson /ID# 152858
New Brunswick, New Jersey, United States
St. Joseph's Regional Medical /ID# 157759
Totowa, New Jersey, United States
Albuquerque Clinical Trials, Inc /ID# 154747
Albuquerque, New Mexico, United States
Bosque Women's Care /ID# 147084
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center /ID# 148749
Brooklyn, New York, United States
Scott Research Inc. /ID# 161704
Laurelton, New York, United States
Manhattan Medical Research /ID# 145175
New York, New York, United States
Columbia Univ Medical Center /ID# 145334
New York, New York, United States
Hamburg Regional Gynecology Gr /ID# 161705
Orchard Park, New York, United States
OB.GYN Associates of WNY /ID# 161665
West Seneca, New York, United States
PMG Research of Charlotte /ID# 145432
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC /ID# 154679
Charlotte, North Carolina, United States
Carolina Women's Research and Wellness Center /ID# 145356
Durham, North Carolina, United States
Unified Women's Clinical Research-Greensboro /ID# 155543
Greensboro, North Carolina, United States
Pinewest Ob-Gyn, Inc. /ID# 151743
High Point, North Carolina, United States
Eastern Carolina Women's Centr /ID# 145386
New Bern, North Carolina, United States
Unified Women's Clinical Resea /ID# 145353
Raleigh, North Carolina, United States
PMG Research of Wilmington /ID# 152555
Wilmington, North Carolina, United States
Trinity Health Center Town /ID# 147102
Minot, North Dakota, United States
Clinical Inquest Center Ltd /ID# 147107
Beavercreek, Ohio, United States
CTI Clinical Research Center /ID# 145428
Cincinnati, Ohio, United States
The Christ Hospital /ID# 149244
Cincinnati, Ohio, United States
University of Cincinnati /ID# 145496
Cincinnati, Ohio, United States
Univ Hosp Cleveland /ID# 148741
Cleveland, Ohio, United States
The Ohio State University /ID# 145444
Columbus, Ohio, United States
Aventiv Research, Inc. /ID# 145492
Columbus, Ohio, United States
Aventiv Research, Inc. /ID# 162896
Columbus, Ohio, United States
Wright State University & CTRA /ID# 145512
Fairborn, Ohio, United States
University of Toledo /ID# 145403
Toledo, Ohio, United States
Oregon Health and Science University /ID# 155705
Portland, Oregon, United States
Main Line Fertility Center /ID# 150099
Bryn Mawr, Pennsylvania, United States
OB/GYN Associates of Erie /ID# 157935
Erie, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 145231
Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 145470
Philadelphia, Pennsylvania, United States
Drexel Univ College of Med /ID# 149789
Philadelphia, Pennsylvania, United States
Frontier Clinical Research /ID# 162091
Smithfield, Pennsylvania, United States
Vista Clinical Research /ID# 148767
Columbia, South Carolina, United States
University Medical Group /ID# 148777
Greenville, South Carolina, United States
Venus Gynecology, LLC /ID# 145336
Myrtle Beach, South Carolina, United States
James T. Martin, Jr., MD., Obs /ID# 148755
North Charleston, South Carolina, United States
Palmetto Clinical Research /ID# 150992
Summerville, South Carolina, United States
Brown Clinic, PLLP /ID# 154372
Watertown, South Dakota, United States
Holston Medical Group /ID# 145449
Bristol, Tennessee, United States
Chattanooga Medical Research /ID# 145184
Chattanooga, Tennessee, United States
WR-ClinSearch /ID# 145205
Chattanooga, Tennessee, United States
The Jackson Clinic, PA /ID# 145303
Jackson, Tennessee, United States
Research Memphis Associates, LLC /ID# 150100
Memphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 145224
Nashville, Tennessee, United States
Lotus Gynecology /ID# 148479
Austin, Texas, United States
AA (Austin Area) ObGyn PLLC /ID# 205696
Austin, Texas, United States
Sirius Clinical Research, LLC /ID# 154749
Austin, Texas, United States
Gadolin Research, LLC /ID# 201383
Beaumont, Texas, United States
Center for Assisted Reprod. /ID# 154748
Bedford, Texas, United States
Texas Health Presbyterian Hosp /ID# 150098
Dallas, Texas, United States
UT Southwestern Medical Center /ID# 145201
Dallas, Texas, United States
Baylor Scott & White /ID# 170430
Fort Worth, Texas, United States
Signature Gyn Services /ID# 145534
Fort Worth, Texas, United States
Willowbend Health and Wellness - Frisco /ID# 145245
Frisco, Texas, United States
Next Innovative Clinical Research /ID# 203863
Houston, Texas, United States
Advances in Health, Inc. /ID# 145425
Houston, Texas, United States
Houston Methodist Hospital /ID# 170586
Houston, Texas, United States
Precision Research Institute - Houston /ID# 154370
Houston, Texas, United States
The Woman's Hospital of Texas /ID# 145316
Houston, Texas, United States
Centex Studies, Inc /ID# 148776
Houston, Texas, United States
FMC Science /ID# 150981
Lampasas, Texas, United States
Clinical Trials of Texas, Inc /ID# 147100
San Antonio, Texas, United States
VIP Trials /ID# 151745
San Antonio, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 145363
San Antonio, Texas, United States
Houston Ctr for Clin Research /ID# 148799
Sugar Land, Texas, United States
Center of Reproductive Medicin /ID# 145467
Webster, Texas, United States
Corner Canyon Obstetrics and G /ID# 145519
Draper, Utah, United States
Tanner Clinic /ID# 148786
Layton, Utah, United States
Revere Health /ID# 145540
Pleasant Grove, Utah, United States
Southampton Women's Health /ID# 151691
Franklin, Virginia, United States
Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477
Newport News, Virginia, United States
Clinical Research Partners, LL /ID# 145392
North Chesterfield, Virginia, United States
Clinical Research Partners, LL /ID# 145416
North Chesterfield, Virginia, United States
Clinical Trials Virginia, Inc. /ID# 145430
Richmond, Virginia, United States
Alliance Womens Health /ID# 148770
Richmond, Virginia, United States
Tidewater Clinical Research /ID# 145397
Virginia Beach, Virginia, United States
Clinical Research Adv, Inc. /ID# 149257
Puyallup, Washington, United States
Virginia Mason Medical Center /ID# 145387
Seattle, Washington, United States
Seattle Women's Health, Research, Gynecology /ID# 145341
Seattle, Washington, United States
North Spokane Women's Health /ID# 145382
Spokane, Washington, United States
Madigan Army Medical Center /ID# 145186
Tacoma, Washington, United States
Strand Clinic /ID# 152582
St. John's, Newfoundland and Labrador, Canada
Medicor Research Inc /ID# 151453
Greater Sudbury, Ontario, Canada
The Ottawa Hospital /ID# 148927
Ottawa, Ontario, Canada
Mount Sinai Hosp.-Toronto /ID# 148972
Toronto, Ontario, Canada
Victory Reproductive Care /ID# 149016
Windsor, Ontario, Canada
Puerto Rico Medical Research /ID# 152040
Ponce, , Puerto Rico
Clinical Research Puerto Rico /ID# 149018
San Juan, , Puerto Rico
Rodriguez-Ginorio, San Juan /ID# 145545
San Juan, , Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546
San Juan, , Puerto Rico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related info
Other Identifiers
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M14-702
Identifier Type: -
Identifier Source: org_study_id