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
Active, not recruiting · Phase 3 · NCT04333576
Conditions: Endometriosis
At a glance
- Research payments reported, 2025
- $1.1M
- U.S. investigators named
- 81
- Sites paid
- 88
- Planned or actual enrollment
- 800
About the trial
- Sponsor
- AbbVie
- Tested
- Elagolix (drug), Placebo (drug), Combined Oral Contraceptive (drug)
- Dates
- Started 2020-08-10; completion 2027-07
- Results posted
- Not yet
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 treatmen…
From ClinicalTrials.gov, last updated 2026-06-12. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $1.1M in research payments for this study in 2025 (555 payments).
Products named: Orilissa
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Janeen L. Arbuckle, M.D. OB-GYN (Obstetrics & Gynecology) · Birmingham, AL
- Theodore N. Catranis, M.D. OB-GYN (Obstetrics & Gynecology) · Mobile, AL
- James K. Citty, MD OB-GYN (Obstetrics & Gynecology) · Searcy, AR
- Nathan D. Livers, MD OB-GYN (Obstetrics & Gynecology) · Little Rock, AR
- Melissa G. Austin I, MD OB-GYN (Obstetrics & Gynecology) · Glendale, AZ
- Ernesto M. Gomez, M.D. OB-GYN (Obstetrics & Gynecology) · Mesa, AZ
- Shahram S. Daneshmand, M.D. Maternal-Fetal Medicine (High-Risk Pregnancy) · San Diego, CA
- Ramin H. Farsad, M.D. Family Medicine · Encinitas, CA
- Douglas Young, MD Internal Medicine · Sacramento, CA
- Michael L. Moore, M.D. OB-GYN (Obstetrics & Gynecology) · Denver, CO
- Scott G. Chudnoff, MD OB-GYN (Obstetrics & Gynecology) · Stamford, CT
- Daniel K. Storey, M.D. Family Medicine · Putnam, CT
- James A. Simon, M.D. OB-GYN (Obstetrics & Gynecology) · Washington, DC
- Kwabena Ayesu, MD Internal Medicine · Orlando, FL
- Peter J. Casella, MD OB-GYN (Obstetrics & Gynecology) · Kissimmee, FL
- Benny Esquenazi, MD OB-GYN (Obstetrics & Gynecology) · Pembroke Pines, FL
- Manuel Franco, M.D. Internal Medicine · Miami, FL
- Victoria Garcia, D.O. OB-GYN (Obstetrics & Gynecology) · Doral, FL
- Adrian Garcia Internal Medicine · Miami, FL
- Emad M. Mikhail, M.D. OB-GYN (Obstetrics & Gynecology) · Tampa, FL
- Ivonne M. Reynolds, DO OB-GYN (Obstetrics & Gynecology) · Margate, FL
- Jose W. Rodriguez, M.D. OB-GYN (Obstetrics & Gynecology) · Tampa, FL
- Kenneth M. Sekine, M.D. OB-GYN (Obstetrics & Gynecology) · Jacksonville, FL
- Robert L. Smith JR., M.D. OB-GYN (Obstetrics & Gynecology) · New Port Richey, FL
- Gregory M. Swor, MD Urogynecology · Sarasota, FL
- Allan J. Dinnerstein, M.D. OB-GYN (Obstetrics & Gynecology) · Fort Stewart, GA
- Soyini M. Hawkins, MD, MPH OB-GYN (Obstetrics & Gynecology) · Peachtree Corners, GA
- Melinda Miller-thrasher, M.D. Specialist · Atlanta, GA
- Serena D. Tidwell, M.D. Specialist · Columbus, GA
- Alvadore P. Osborn, D.O. OB-GYN (Obstetrics & Gynecology) · West Des Moines, IA
- Bill T. Laitinen, MD Family Medicine · Middleton, ID
- Steven W. Robison, MD OB-GYN (Obstetrics & Gynecology) · Idaho Falls, ID
- Arundathi G. Prasad, M.D. OB-GYN (Obstetrics & Gynecology) · Indianapolis, IN
- Gordon B. Clark, MD Obesity Medicine · Shawnee, KS
- David A. Grainger, MD Fertility (Reproductive Endocrinology) · Wichita, KS
- Samuel M. Alexander, M.D. OB-GYN (Obstetrics & Gynecology) · Metairie, LA
- Albert I. Tydings, MD OB-GYN (Obstetrics & Gynecology) · Covington, LA
- Michele S. Goh, MD Internal Medicine · Hudson, MA
- Cheryl A. Sadow, MD Radiology · Boston, MA
- Vikram A. Sahni, M.D. Radiology · Wellesley, MA
- Nisha I. Sainani, M.D. Radiology · Boston, MA
- Steven Behram, MD OB-GYN (Obstetrics & Gynecology) · Rockville, MD
- Issam A. Daya, M.D. OB-GYN (Obstetrics & Gynecology) · Towson, MD
- Gerrit Schipper, MD OB-GYN (Obstetrics & Gynecology) · Frederick, MD
- Jay M. Berman, MD OB-GYN (Obstetrics & Gynecology) · Southfield, MI
- Alyson Miser, M.D. OB-GYN (Obstetrics & Gynecology) · Great Falls, MT
- Rebecca F. Dunsmoor-su, MD OB-GYN (Obstetrics & Gynecology) · Morrisville, NC
- Jennie J. Hauschka, MD OB-GYN (Obstetrics & Gynecology) · Charlotte, NC
- Andrea S. Lukes, M.D. OB-GYN (Obstetrics & Gynecology) · Durham, NC
- Jin Hee J. Kim, MD OB-GYN (Obstetrics & Gynecology) · New York, NY
- Navpriya Oberoi, MD OB-GYN (Obstetrics & Gynecology) · Fayetteville, NY
- Ja Hyun Shin, MD OB-GYN (Obstetrics & Gynecology) · Bronx, NY
- Radha Syed, MD OB-GYN (Obstetrics & Gynecology) · Staten Island, NY
- Josette D'amato, DO OB-GYN (Obstetrics & Gynecology) · Dayton, OH
- David N. Dhanraj, M.D. OB-GYN (Obstetrics & Gynecology) · Cincinnati, OH
- Daniel L. Whitmer, M.D. Family Medicine · Beavercreek, OH
- Nora J. Doty, MD OB-GYN (Obstetrics & Gynecology) · Portland, OR
- Stephanie J. Estes, M.D. Fertility (Reproductive Endocrinology) · Hershey, PA
- Timothy G. Grube, D.O. OB-GYN (Obstetrics & Gynecology) · Frackville, PA
- Suneeta A. Senapati, MD Fertility (Reproductive Endocrinology) · Philadelphia, PA
- Ivan Guzman-ortiz SR., MD OB-GYN (Obstetrics & Gynecology) · Cayey, PR
- Henry A. Rodriguez-ginorio, M.D. OB-GYN (Obstetrics & Gynecology) · San Juan, PR
- Tasha M. Boone, MD Family Medicine · Irmo, SC
- Ronnie M. Givens II, MD OB-GYN (Obstetrics & Gynecology) · Summerville, SC
- Paul B. Miller, M.D. Fertility (Reproductive Endocrinology) · Greenville, SC
- Janet L. Dittus, MD OB-GYN (Obstetrics & Gynecology) · Nashville, TN
- Daniel S. Harnsberger, M.D. OB-GYN (Obstetrics & Gynecology) · Chattanooga, TN
- Dawn D. Black, M.D. OB-GYN (Obstetrics & Gynecology) · Houston, TX
- Sandra M. Hurtado, M.D. OB-GYN (Obstetrics & Gynecology) · Houston, TX
- Jeff Livingston, MD OB-GYN (Obstetrics & Gynecology) · Irving, TX
- Anna M. Lizama Clark, M.D. OB-GYN (Obstetrics & Gynecology) · Dallas, TX
- Brian K. Macgillivray, MD Family Medicine · San Antonio, TX
- Bassem Maximos, MD, MPH, PA OB-GYN (Obstetrics & Gynecology) · League City, TX
- Francesca Perugini, M.D. OB-GYN (Obstetrics & Gynecology) · Dallas, TX
- Yvette M. Poindexter, MD Family Medicine · Pearland, TX
- John A. Whitfield, M.D. OB-GYN (Obstetrics & Gynecology) · Fort Worth, TX
- Stephen F. Richardson, M.D. Research Study Specialist · Sandy, UT
- David B. Young, D.O. OB-GYN (Obstetrics & Gynecology) · Pleasant Grove, UT
- Camilla C. Hersh, M.D. OB-GYN (Obstetrics & Gynecology) · Reston, VA
- Franklin C. Morgan, M.D. OB-GYN (Obstetrics & Gynecology) · Norfolk, VA
- Stephen P. Pound OB-GYN (Obstetrics & Gynecology) · North Chesterfield, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Tidewater Clinical Research Inc $116,252
- Exordia Medical Research Inc $84,250
- Javara Inc $80,280
- Columbia University Medical Center $62,626
- Access Clinical Trials Inc $47,906
- Cactus Clinical Research Inc $39,053
- Wayne State University $34,838
- Sunbelt Research Group LLC $32,326
- Clinical Research PArtners LLC $29,937
- Interspond LLC $28,876
- University of Texas Health Science Center at Houston $27,731
- Dct-Hcwc LLC $27,481
- Biocentric Healthcare $26,502
- Chattanooga Medical Research LLC $26,347
- Gcp Clinical Research LLC $25,704
- Applied Research Center of Akansas $20,050
- Hospital of Univ of Pennsylvania, PA $19,854
- Signature Gyn Services PLLC $19,383
- Helix Biomedics LLC $18,454
- Dct Stone Oak LLC $18,299
- Asr LLC $17,909
- Jfk University Medical Center, NJ $17,346
- Doral Medical Research LLC $17,338
- Richmond Obgyn Associates PC $15,015
- Prisma Health Greenville Memorial Hospital, SC $14,489
- Vida Clinical Research LLC $13,730
- Michael L Moore MD $13,634
- Carolina Womens Research and Wellness Center $12,898
- Innovo Research Inc $12,700
- Virginia Womens Health Associates $12,249
- Clinical Trials Management LLC $11,655
- Northern California Research $11,404
- Pivotal Clinical Research & Associates LLC $10,757
- Advances in Health Inc $10,725
- Omega Research Orlando LLC $10,717
- Pennsylvania State University $10,304
- Clinical Associates of Orlando LLC $9,950
- Cny Women S Wellness PLLC $8,899
- Highland Clinical Research $8,613
- Cedar Health Research LLC $7,706
- Serena D Tidwell MD PC DBA Midtown Obgyn North $6,741
- Pleasant Grove Clinic $6,355
- Cornell University Weill Medical College $6,078
- Royal Research Corp $5,927
- Solutions Through Advanced Research Inc $5,759
- Henry A Rodriguez Ginorio LLC $5,000
- Continental Clinical Solutions LLC $4,854
- Am Health Network of Indiana LLC $4,171
- Office of James A Simon MD PC $4,049
- Wright State University $3,689
- South Florida Clinical Research $3,378
- Peritus Imaging Inc $3,060
- Boeson Research LLC $3,033
- Clinical Inquest Center LTD $3,000
- Journey Medical Research Institute $2,832
- Cypress Medical Research Center LLC $2,604
- Women S & Family Care LLC $2,470
- A&b Clinical Research Inc $2,411
- Ns Imaging Related Services Inc $2,295
- Wright State Physicians Inc $2,034
- Investigators Research Group LLC $1,907
- Palmetto Primary Care Physicians $1,750
- Seattle Crc LLC $1,527
- Genesis Clinical Research and Consulting $1,381
- Diagnamics Inc $1,240
- Care Access Research LLC $1,025
- Cactus Clinical Research $940
- Royal Research Corporation $649
- Columbia University Med Center $584
- Advanced Specialty Research Asr LLC $543
- Sbl Special Services LLC $443
- Chattanooga Gastroenterology PC $428
- Maimonides Medical Center, NY $398
- Advanced Medical Concepts Psc $378
- Women S Healthcare Associates PA $350
- Gold Coast Health Research LLC $298
- The Miami Research Group $297
- Bassem Maximos MD Mph PA DBA Maximos Obgyn $251
- Suncoast Clinical Research $237
- Advanced Womens Health Institute $223
- Womens and Family Care and Modern Dermatology $200
- Continental Clinical Sols LLC $199
- Physician Care Clinical Research $173
- White County Medical Center, AR $164
- Midtown Obgyn $145
- Highland Clinic Research $122
- University of Alabama Hospital, AL $122
- University of South Florida Office of Clinical Research $80
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.