A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Completed · Phase 3 · NCT03213457
Conditions: Endometriosis
At a glance
- Research payments reported, 2025
- $39,751
- U.S. investigators named
- 9
- Sites paid
- 8
- Planned or actual enrollment
- 681
About the trial
- Sponsor
- AbbVie
- Tested
- Estradiol/Norethindrone Acetate (drug), Placebo for Elagolix (drug), Elagolix (drug), Placebo for E2/NETA (drug)
- Dates
- Started 2017-07-07; completion 2023-12-06
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2024-12-20. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $39,751 in research payments for this study in 2025 (14 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
- Alberto J. Odio, M.D. Family Medicine · Simi Valley, CA
- Emad M. Mikhail, M.D. OB-GYN (Obstetrics & Gynecology) · Tampa, FL
- Charles E. Miller, M.D. OB-GYN (Obstetrics & Gynecology) · Naperville, IL
- Alison A. Rodriguez, MD OB-GYN (Obstetrics & Gynecology) · New Orleans, LA
- Bun B. Siu, M.D., PH.D. Student in an Organized Health Care Education/Training Program · Ann Arbor, MI
- Rebecca F. Dunsmoor-su, MD OB-GYN (Obstetrics & Gynecology) · Morrisville, NC
- Jin Hee J. Kim, MD OB-GYN (Obstetrics & Gynecology) · New York, NY
- Carlos A. Santos, MD OB-GYN (Obstetrics & Gynecology) · West Seneca, NY
- Scott J. Zuccala, D.O. OB-GYN (Obstetrics & Gynecology) · Orchard Park, NY
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Advanced Gynecologic Surgery Institute the $19,321
- Millennium Clinical Trials LLC $5,500
- Clinical Trials Management LLC $3,978
- Seattle Crc LLC $3,500
- Columbia University Medical Center $2,995
- Empirican Prn Inc DBA Circuit Clinical $2,700
- Tilda Research Inc $1,715
- University of South Florida $42
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.