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
ELARIS EM-COC
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
1 other identifier
interventional
800
2 countries
179
Brief 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. 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Longer than P75 for phase_3
179 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2020
CompletedFirst Posted
Study publicly available on registry
April 3, 2020
CompletedStudy Start
First participant enrolled
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
November 19, 2025
November 1, 2025
8.6 years
April 2, 2020
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Month 3
Secondary Outcomes (1)
Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale
Month 3
Study Arms (3)
Double-Blind: Placebo
PLACEBO 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.
Double-Blind: Elagolix
EXPERIMENTALParticipants 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.
Double-Blind: Elagolix + COC
EXPERIMENTALParticipants 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.
Interventions
Tablet:Oral
Tablet:Oral
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (179)
Pinnacle Research Group /ID# 217062
Anniston, Alabama, 36207, United States
ACCEL Research Sites /ID# 218044
Birmingham, Alabama, 35218, United States
Alabama Clinical Therapeutics /ID# 217166
Birmingham, Alabama, 35235-3430, United States
Alabama Clinical Therapeutics /ID# 222301
Birmingham, Alabama, 35235-3430, United States
University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503
Birmingham, Alabama, 35294-7333, United States
Trinity Research Group /ID# 246932
Dothan, Alabama, 36301, United States
Southern Women's Specialists PC /ID# 217143
Fairhope, Alabama, 36532-3029, United States
Women's Health Alliance of Mobile /ID# 222591
Mobile, Alabama, 36604-1410, United States
Mobile, OBGYN P.C. /ID# 217135
Mobile, Alabama, 36608, United States
North Valley Women's Care /ID# 217092
Glendale, Arizona, 85308, United States
MomDoc Womens Health Research /ID# 221661
Phoenix, Arizona, 85251, United States
Applied Research Center of Arkansas /ID# 248494
Little Rock, Arkansas, 72212-4187, United States
Unity Health- Searcy Medical Center /ID# 217050
Searcy, Arkansas, 72143-4802, United States
Diagnamics Inc. /ID# 225385
Encinitas, California, 92024, United States
Atella Clinical Research /ID# 224024
La Palma, California, 90623, United States
Valley Renal Medical Group Research /ID# 228614
Northridge, California, 91324-4622, United States
Futura Research, Org /ID# 217361
Norwalk, California, 90650, United States
Northern California Research /ID# 217301
Sacramento, California, 95821-2640, United States
A & B Clinical Research /ID# 224471
San Diego, California, 92103-3363, United States
Advanced Clinical Research Center, LLC /ID# 248398
San Diego, California, 92119-3434, United States
Rocky Mountain Internal Medicine - Aurora /ID# 245161
Aurora, Colorado, 80012-4505, United States
Velocity Clinical Research - Denver /ID# 217297
Denver, Colorado, 80209-3804, United States
Boeson Research - Grand Junction /ID# 248580
Grand Junction, Colorado, 81505-1018, United States
Advanced Women's Health Institute /ID# 217150
Greenwood Village, Colorado, 80111, United States
Red Rocks OB/GYN /ID# 217103
Lakewood, Colorado, 80228-1810, United States
Reproductive Assoc of Delaware /ID# 227764
Newark, Delaware, 19713, United States
Medstar Health Research Institute /ID# 244937
Washington D.C., District of Columbia, 20010, United States
James A. Simon, MD, PC /ID# 218116
Washington D.C., District of Columbia, 20036, United States
Topaz Clinical Research /ID# 218615
Apopka, Florida, 32703-5835, United States
Ideal Clinical Research Inc. /ID# 218832
Aventura, Florida, 33180, United States
Helix Biomedics, LLC /ID# 218649
Boynton Beach, Florida, 33436-6634, United States
Olympian Clinical Research /ID# 244426
Clearwater, Florida, 33756, United States
Women's Medical Research Group /ID# 218524
Clearwater, Florida, 33759, United States
Doral Medical Research, LLC /ID# 225146
Doral, Florida, 33166-6658, United States
Universal Axon Clinical Research /ID# 248553
Doral, Florida, 33166, United States
KO Clinical Research, LLC /ID# 217173
Fort Lauderdale, Florida, 33316, United States
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061
Fort Myers, Florida, 33912, United States
Solutions Through Adv Rch /ID# 220973
Jacksonville, Florida, 32256, United States
Care Partners Clinical Research /ID# 217042
Jacksonville, Florida, 32277, United States
Vida Clinical Research /ID# 245325
Kissimmee, Florida, 34741-2358, United States
Kissimmee Clinical Research /ID# 224749
Kissimmee, Florida, 34741, United States
South Florida Wellness & Clinic /ID# 222897
Margate, Florida, 33063, United States
GRE Clinical Research, LLC /ID# 246579
Miami, Florida, 33145-2457, United States
Gold Coast Health Research, LLC /ID# 248624
Miami, Florida, 33155-1402, United States
Admed Research LLC /ID# 227679
Miami, Florida, 33173, United States
The Miami Research Group Inc /ID# 246578
Miami, Florida, 33174, United States
Innova Pharma Research /ID# 245354
Miami, Florida, 33175-8802, United States
Ocean Blue Medical Research Center, Inc /ID# 217286
Miami Springs, Florida, 33166, United States
Salom Tangir, LLC /ID# 217273
Miramar, Florida, 33027, United States
Suncoast Clinical Research Pasco County /ID# 217249
New Port Richey, Florida, 34652, United States
Advanced Research Institute, Inc /ID# 217206
New Port Richey, Florida, 34653, United States
Segal Institute for Clinical Research /ID# 221518
North Miami, Florida, 33161-5821, United States
A Premier Medical Research of FL /ID# 216908
Orange City, Florida, 32763-2833, United States
Osceola Gynecology, LLC - Orlando /ID# 227194
Orlando, Florida, 32806-5412, United States
Omega Research Group /ID# 216907
Orlando, Florida, 32808, United States
Clinical Associates of Orlando /ID# 218114
Orlando, Florida, 32819-8900, United States
Duplicate_Suncoast Clinical Research - Palm Harbor /ID# 219133
Palm Harbor, Florida, 34684, United States
Royal Research,Corp /ID# 221356
Pembroke Pines, Florida, 33027-1003, United States
Physician Care Clin. Res., LLC /ID# 217264
Sarasota, Florida, 34239, United States
Tampa General Hospital - Tampa - General Circle /ID# 217146
Tampa, Florida, 33606, United States
GCP Clinical Research, LLC /ID# 217232
Tampa, Florida, 33609-4044, United States
Virtus Research Consultants, LLC /ID# 217052
Wellington, Florida, 33414, United States
Florida Premier Research Institute, LLC /ID# 224499
Winter Park, Florida, 32789-4681, United States
Paramount Research Solutions /ID# 218769
Alpharetta, Georgia, 30005, United States
Academia of Women's Health & Endoscopic Surgery /ID# 217260
Atlanta, Georgia, 30328, United States
Gyn & Fertility Specialists /ID# 223015
Atlanta, Georgia, 30342-1731, United States
Atlanta Women's Research Institute /ID# 217303
Atlanta, Georgia, 30342, United States
Paramount Research Solutions - College Park /ID# 217358
College Park, Georgia, 30349-3103, United States
Duplicate_Columbus Regional Research Ins /ID# 217294
Columbus, Georgia, 31904, United States
Midtown OBGYN North /ID# 222300
Columbus, Georgia, 31909-5715, United States
Innovative Women's HealthCare Solutions - Smyrna /ID# 223692
Smyrna, Georgia, 30082-5166, United States
Journey Medical Research Institute - Snellville /ID# 229774
Snellville, Georgia, 30078-6191, United States
Leavitt Womens Healthcare /ID# 217118
Idaho Falls, Idaho, 83404, United States
Womens Healthcare Assoc, DBA /ID# 222153
Idaho Falls, Idaho, 83404, United States
Sonora Clinical Research /ID# 222147
Meridian, Idaho, 83646-1144, United States
Asr, Llc /Id# 217094
Nampa, Idaho, 83687, United States
Women's Health Care Center Of Chicago /ID# 245164
Chicago, Illinois, 60639-2103, United States
Alliance for Multispecialty Research, LLC /ID# 217226
Oak Brook, Illinois, 60523, United States
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372
Park Ridge, Illinois, 60068, United States
American Health Network of IN, LLC (Avon) /ID# 218023
Avon, Indiana, 46123-7960, United States
Investigators Research Group, LLC /ID# 222891
Brownsburg, Indiana, 46112, United States
Women's Health Advantage /ID# 246580
Fort Wayne, Indiana, 46825, United States
University of Iowa Hospitals and Clinics /ID# 217144
Iowa City, Iowa, 52242, United States
The Iowa Clinic, PC /ID# 217351
West Des Moines, Iowa, 50266-8216, United States
GTC Research /ID# 217051
Shawnee Mission, Kansas, 66218, United States
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040
Wichita, Kansas, 67205-1138, United States
Cypress Medical Research Ctr /ID# 217093
Wichita, Kansas, 67226, United States
Clinical Trials Management - Metairie /ID# 217054
Covington, Louisiana, 70433-4966, United States
Clinical Trials Management, LLC - Covington /ID# 217291
Covington, Louisiana, 70433, United States
Horizon Research Group /ID# 217100
Eunice, Louisiana, 70535, United States
Praetorian Pharmaceutical Research /ID# 217159
Marrero, Louisiana, 70072, United States
Southern Clinical Research A /ID# 218028
Metairie, Louisiana, 70001, United States
Women's Health Clinic /ID# 217205
Shreveport, Louisiana, 71118-3133, United States
SBL Special Services LLC /ID# 224899
Frederick, Maryland, 21702-4301, United States
Congressional OBGYN /ID# 245349
Rockville, Maryland, 20850-8726, United States
Continental Clinical Solutions /ID# 217053
Towson, Maryland, 21204, United States
NECCR Fall River LLC /ID# 217108
Fall River, Massachusetts, 02720-2972, United States
Exordia Medical Research, Inc /ID# 217116
Fall River, Massachusetts, 02723, United States
Great Lakes Research Group - Bay City /ID# 217099
Bay City, Michigan, 48706, United States
Wayne State University, C.S. Mott Center /ID# 248422
Detroit, Michigan, 48201-1406, United States
Saginaw Valley Med Res Group /ID# 217296
Saginaw, Michigan, 48604, United States
Center for Reproductive Medicine and Robotic Surgery /ID# 223494
St Louis, Missouri, 63141, United States
Boeson Research - Great Falls /ID# 248560
Great Falls, Montana, 59405-5315, United States
Boeson Research - Missoula /ID# 248559
Missoula, Montana, 59804-7419, United States
Womens Clinic of Lincoln, P.C. /ID# 217136
Lincoln, Nebraska, 68510, United States
Private practice: Dr. Rex G. Mabey JR /ID# 217134
Las Vegas, Nevada, 89128, United States
Dr. Nader and Associates M.D. P.C. /ID# 223571
North Las Vegas, Nevada, 89030-7187, United States
Cooper University Hospital /ID# 227208
Camden, New Jersey, 08103, United States
Jersey Shore University Medical Center /ID# 217138
Neptune City, New Jersey, 07753-4859, United States
Rutgers Robert Wood Johnson /ID# 246933
New Brunswick, New Jersey, 08901, United States
Maimonides Medical Center /ID# 248493
Brooklyn, New York, 11219, United States
Invision Health /ID# 218687
Buffalo, New York, 14221-5771, United States
Widewaters Gynecology /ID# 225621
East Syracuse, New York, 13057-3072, United States
Parkmed NYC /ID# 224333
New York, New York, 10017-4709, United States
Columbia Univ Medical Center /ID# 217113
New York, New York, 10032-3725, United States
New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329
New York, New York, 10065, United States
Richmond OB/GYN Associates PC /ID# 224833
Staten Island, New York, 10306, United States
Duplicate_PMG Research of Charlotte /ID# 217224
Charlotte, North Carolina, 28209, United States
Tyron Medical Partners, PLLC /ID# 245286
Charlotte, North Carolina, 28211-5055, United States
Carolina Women's Research and Wellness Center /ID# 217133
Durham, North Carolina, 27713, United States
Eastern Carolina Women's Centr /ID# 222358
New Bern, North Carolina, 28562, United States
Accellacare Wilmington /ID# 217097
Wilmington, North Carolina, 28401, United States
Carolina Medical Trials - Winston-Salem /ID# 223002
Winston-Salem, North Carolina, 27103-4109, United States
Unified Women's Clinical Research /ID# 217132
Winston-Salem, North Carolina, 27103, United States
Unified Women's Clinical Research /ID# 218339
Winston-Salem, North Carolina, 27103, United States
Clinical Inquest Center Ltd /ID# 217961
Beavercreek, Ohio, 45431-2573, United States
Neuro-Behavioral Clinical Research, Inc. /ID# 224026
Canton, Ohio, 44720, United States
Seven Hills Clinical Research Group /ID# 224941
Cincinnati, Ohio, 45255, United States
Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 217349
Cincinnati, Ohio, 45267-0585, United States
MetroHealth Medical Center /ID# 224392
Cleveland, Ohio, 44109, United States
Central Ohio Clinical Research /ID# 217059
Columbus, Ohio, 43213-3399, United States
HWC Women's Research Center /ID# 246619
Englewood, Ohio, 45322, United States
Wright State Physicians Health Center /ID# 217272
Fairborn, Ohio, 45324, United States
Marion Ob/Gyn Inc. /ID# 244175
Marion, Ohio, 43302-6318, United States
Univ Hosp Landerbrook /ID# 217065
Mayfield Heights, Ohio, 44124, United States
AC Clinical Research /ID# 227356
Tiffin, Ohio, 44883, United States
Grube Gynecology /ID# 245132
Frackville, Pennsylvania, 17931-2105, United States
Penn State University and Milton S. Hershey Medical Center /ID# 217057
Hershey, Pennsylvania, 17033-2360, United States
University of Pennsylvania /ID# 217243
Philadelphia, Pennsylvania, 19104-5502, United States
reading Hospital /ID# 223599
Wyomissing, Pennsylvania, 19611, United States
Vista Clinical Research /ID# 217151
Columbia, South Carolina, 29201, United States
University Medical Group /ID# 217355
Greenville, South Carolina, 29605, United States
Vitalink Research - Greenville /ID# 217075
Greenville, South Carolina, 29615, United States
Duplicate_Palmetto Clinical Research /ID# 217069
Summerville, South Carolina, 29485-7539, United States
Biocentric Healthcare Research /ID# 248582
West Columbia, South Carolina, 29169-3612, United States
Chattanooga Research and Medicine /ID# 217045
Chattanooga, Tennessee, 37412-3964, United States
Research Memphis Associates, LLC /ID# 218022
Memphis, Tennessee, 38119-3895, United States
Access Clinical Trials, Inc. /ID# 217055
Nashville, Tennessee, 37203, United States
DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095
Dallas, Texas, 75230, United States
Cedar Health Research /ID# 224407
Dallas, Texas, 75251-2202, United States
Duplicate_The University of Texas Southwestern Medical Center /ID# 217048
Dallas, Texas, 75390-8575, United States
Signature Gyn Services /ID# 217299
Fort Worth, Texas, 76104, United States
Progressive Women's Health /ID# 248402
Friendswood, Texas, 77546-3988, United States
Willowbend Health and Wellness - Frisco /ID# 217354
Frisco, Texas, 75035, United States
FMC Science, LLC - OB/GYN - Georgetown /ID# 218654
Georgetown, Texas, 78626-8185, United States
UTHealth Women's Research Program - Memorial City /ID# 217362
Houston, Texas, 77024, United States
OBGYN Medical Center Associates - Medical Center Office /ID# 245346
Houston, Texas, 77054-2934, United States
Centex Studies, Inc. - Houston /ID# 217357
Houston, Texas, 77058, United States
FMC Science /ID# 217047
Lampasas, Texas, 76550, United States
Maximos OB/GYN /ID# 229385
League City, Texas, 77573-2681, United States
Advances in Health, Inc. /ID# 217220
Pearland, Texas, 77854, United States
Clinical Trials of Texas, Inc /ID# 217039
San Antonio, Texas, 78229, United States
VIP Trials /ID# 217261
San Antonio, Texas, 78230, United States
Discovery Clinical Trials-San Antonio /ID# 218547
San Antonio, Texas, 78258, United States
Center of Reproductive Medicine /ID# 217241
Webster, Texas, 77598, United States
Corner Canyon Obstetrics and G /ID# 217289
Draper, Utah, 84020, United States
Duplicate_Physicians Research Options /ID# 217302
Pleasant Grove, Utah, 84062, United States
Highland Clinical Research /ID# 224052
Salt Lake City, Utah, 84124, United States
Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063
Newport News, Virginia, 23606, United States
Clinical Research Partners /ID# 217359
North Chesterfield, Virginia, 23235, United States
Virginia Women's Health Associates /ID# 227677
Reston, Virginia, 20190-3215, United States
Clinical Trials Virginia, Inc. /ID# 217222
Richmond, Virginia, 23225, United States
Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149
Richmond, Virginia, 23226-3786, United States
Tidewater Clinical Research /ID# 217152
Virginia Beach, Virginia, 23456, United States
Seattle Clinical Research Center /ID# 217117
Seattle, Washington, 98105, United States
North Spokane Women's Health /ID# 217356
Spokane, Washington, 99207, United States
Advanced Medical Concepts. PSC /ID# 221337
Cidra, 00739, Puerto Rico
Henry A. Rodriguez Ginorio, MD /ID# 217233
San Juan, 00917-5022, Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235
San Juan, 00935, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2020
First Posted
April 3, 2020
Study Start
August 10, 2020
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
June 1, 2030
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.