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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Elagolix; Drug: Placebo; Drug: Combined Oral Contraceptive

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Double-Blind: Placebo; Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.	Drug: Elagolix; Tablet:Oral; Other Names: ABT-620; Orilissa; Drug: Placebo; Tablet:Oral; Drug: Combined Oral Contraceptive; Tablet:Oral
Experimental: Double-Blind: Elagolix; Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.	Drug: Elagolix; Tablet:Oral; Other Names: ABT-620; Orilissa; Drug: Combined Oral Contraceptive; Tablet:Oral
Experimental: Double-Blind: Elagolix + COC; Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months.	Drug: Elagolix; Tablet:Oral; Other Names: ABT-620; Orilissa; Drug: Combined Oral Contraceptive; Tablet:Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 3

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Endometriosis; Elagolix; Orilissa; Combined oral contraceptives (COC)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pelvic Pain; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Endometriosis; Dysmenorrhea; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Drug Combinations; Contraceptives, Oral, Combined; elagolix
• Other Study ID Numbers: M18-969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes