Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Completed · Phase 3 · NCT03271489
Conditions: Heavy Menstrual Bleeding, Uterine Fibroids
At a glance
- Research payments reported, 2025
- $138,427
- U.S. investigators named
- 12
- Sites paid
- 12
- Planned or actual enrollment
- 478
About the trial
- Sponsor
- AbbVie
- Tested
- Elagolix (drug), Estradiol /norethindrone acetate (E2/NETA) (drug), E2/NETA Placebo (other), Elagolix Placebo (other)
- Dates
- Started 2017-09-13; completion 2024-06-28
- Results posted
- Yes
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.
From ClinicalTrials.gov, last updated 2025-07-22. Full record, eligibility and contacts (opens in a new tab)
Industry funding
AbbVie Inc. reported $138,427 in research payments for this study in 2025 (37 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
- Tollie B. Elliott SR., M.D. OB-GYN (Obstetrics & Gynecology) · Washington, DC
- Armando N. Gutierrez, MD OB-GYN (Obstetrics & Gynecology) · Tampa, FL
- Anthony N. Imudia, M.D. Fertility (Reproductive Endocrinology) · Wesley Chapel, FL
- Gigi C. Lefebvre, MD Family Medicine · St Petersburg, FL
- Hugo L. Perez, MD OB-GYN (Obstetrics & Gynecology) · Clearwater, FL
- Ivonne M. Reynolds, DO OB-GYN (Obstetrics & Gynecology) · Margate, FL
- Jose W. Rodriguez, M.D. OB-GYN (Obstetrics & Gynecology) · Tampa, FL
- Veronica C. Gillispie, MD OB-GYN (Obstetrics & Gynecology) · New Orleans, LA
- Awoniyi O. Awonuga, MD OB-GYN (Obstetrics & Gynecology) · Southfield, MI
- Jin Hee J. Kim, MD OB-GYN (Obstetrics & Gynecology) · New York, NY
- Angelina K. Gangestad, MD OB-GYN (Obstetrics & Gynecology) · Cleveland, OH
- Parke J. Hedges OB-GYN (Obstetrics & Gynecology) · San Antonio, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Gcp Clinical Research LLC $49,257
- Clinical Trials of Texas Inc $22,592
- Jedidiah Clinical Research $19,630
- Columbia University Medical Center $15,783
- Advanced Research Institute Inc $12,466
- Sandhill Research LLC $6,700
- Wayne State University $4,617
- Ochsner Medical Center Acute, LA $3,545
- Rainbow Babies and Childrens Hospital, OH $2,000
- South Florida Clinical Research Institute LLC $1,000
- Emerson Clinical Research Institute $636
- University of South Florida $202
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.