ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT03271489
Public ClinicalTrials.gov record NCT03271489. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
ClinicalTrials.gov public records Last synced May 16, 2026, 11:22 PM EDT
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Study identification
- NCT ID
- NCT03271489
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- AbbVie
- Industry
- Enrollment
- 478 participants
Conditions and interventions
Conditions
Interventions
- E2/NETA Placebo Other
- Elagolix Drug
- Elagolix Placebo Other
- Estradiol /norethindrone acetate (E2/NETA) Drug
Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2017
- Primary completion
- Jun 27, 2024
- Completion
- Jun 27, 2024
- Last update posted
- Jul 21, 2025
2017 – 2024
United States locations
- U.S. sites
- 155
- U.S. states
- 27
- U.S. cities
- 115
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics /ID# 160835 | Birmingham | Alabama | 35235-3430 | — |
| Alabama Clinical Therapeutics /ID# 160927 | Birmingham | Alabama | 35235-3430 | — |
| Choice Research, LLC /ID# 161498 | Dothan | Alabama | 36303 | — |
| Southern Women's Specialists PC /ID# 161531 | Fairhope | Alabama | 36532-3029 | — |
| E Squared Research /ID# 163645 | Huntsville | Alabama | 35801 | — |
| Women's Health Alliance of Mobile /ID# 161443 | Mobile | Alabama | 36604-1410 | — |
| Mobile, OBGYN P.C. /ID# 161530 | Mobile | Alabama | 36608 | — |
| Mesa Obstetricians and Gynecologists /ID# 160955 | Mesa | Arizona | 85209 | — |
| Noble Clinical Research /ID# 166949 | Tucson | Arizona | 85704 | — |
| Vision's Clinical Research-Tucson /ID# 161508 | Tucson | Arizona | 85712 | — |
| Eclipse Clinical Research /ID# 161516 | Tucson | Arizona | 85745 | — |
| Duplicate_Core Healthcare Group /ID# 160858 | Cerritos | California | 90703 | — |
| Diagnamics Inc. /ID# 160950 | Encinitas | California | 92024 | — |
| HRC Fertility /ID# 161493 | Encino | California | 91436 | — |
| SC Clinical Research /ID# 164395 | Garden Grove | California | 92844 | — |
| Duplicate_Duplicate_Marvel Clinical Research /ID# 167297 | Huntington Beach | California | 92647 | — |
| Grossmont Ctr Clin Research /ID# 165120 | La Mesa | California | 91942 | — |
| Olympia Clinical Trials /ID# 201562 | Los Angeles | California | 90036-4667 | — |
| National Research Institute /ID# 160952 | Los Angeles | California | 90057 | — |
| Futura Research, Org /ID# 160924 | Montebello | California | 90640 | — |
| California Medical Research Associates /ID# 161481 | Northridge | California | 91324 | — |
| Northern California Research /ID# 161561 | Sacramento | California | 95821-2640 | — |
| Precision Research Institute - San Diego /ID# 163069 | San Diego | California | 92114-3643 | — |
| MD Strategies Research Centers /ID# 161544 | San Diego | California | 92119 | — |
| Health care Affiliates Medical Group /ID# 163324 | Santa Ana | California | 92704 | — |
| Alta California Medical Group /ID# 163564 | Simi Valley | California | 93065 | — |
| Upland Clinical Research /ID# 164528 | Upland | California | 91786-4027 | — |
| Bayview Research Group LLC /ID# 161484 | Valley Village | California | 91607 | — |
| Advanced RX Clinical Research /ID# 161599 | Westminster | California | 92683-4567 | — |
| Emerson Clinical Research Inst /ID# 162181 | Washington D.C. | District of Columbia | 20011 | — |
| James A. Simon, MD, PC /ID# 160931 | Washington D.C. | District of Columbia | 20036 | — |
| Women's Health Partners /ID# 203577 | Boca Raton | Florida | 33433-7041 | — |
| David Lubetkin MD LLC /ID# 203578 | Boca Raton | Florida | 33486-2269 | — |
| Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910 | Brandon | Florida | 33510-3107 | — |
| Omega Research Maitland, LLC /ID# 160857 | DeBary | Florida | 32713-2260 | — |
| Midland Florida Clinical Research Center /ID# 161487 | DeLand | Florida | 32720-0920 | — |
| KO Clinical Research, LLC /ID# 160928 | Fort Lauderdale | Florida | 33316 | — |
| Sweet Hope Research Specialty Inc /ID# 163522 | Hialeah | Florida | 33016-1897 | — |
| Solutions Through Adv Rch /ID# 160935 | Jacksonville | Florida | 32256 | — |
| Altus Research, Inc /ID# 160912 | Lake Worth | Florida | 33461 | — |
| Wellington Anti-Aging Centre /ID# 203540 | Loxahatchee Groves | Florida | 33470-4937 | — |
| South Florida Wellness & Clinic /ID# 161535 | Margate | Florida | 33063 | — |
| Invictus Clinical Research Group,LLC /ID# 160925 | Miami | Florida | 33144 | — |
| Healthcare Clinical Data, Inc /ID# 160888 | Miami | Florida | 33161 | — |
| Palmetto Professional Research /ID# 161442 | Miami | Florida | 33172 | — |
| Vista Health Research, LLC /ID# 163044 | Miami | Florida | 33176-1032 | — |
| Duplicate_Precision Research Organization /ID# 161522 | Miami Lakes | Florida | 33016-1501 | — |
| Ocean Blue Medical Research Center, Inc /ID# 161549 | Miami Springs | Florida | 33166 | — |
| Salom Tangir, LLC /ID# 162542 | Miramar | Florida | 33027 | — |
| Advanced Research Institute, Inc /ID# 163748 | New Port Richey | Florida | 34653 | — |
| A Premier Medical Research of FL /ID# 201882 | Orange City | Florida | 32763-2833 | — |
| Clinical Associates of Orlando /ID# 160889 | Orlando | Florida | 32819-8900 | — |
| Oncova Clinical Research, Inc. /ID# 160937 | Saint Cloud | Florida | 34769 | — |
| Physician Care Clin. Res., LLC /ID# 161547 | Sarasota | Florida | 34239 | — |
| Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913 | St. Petersburg | Florida | 33709-3113 | — |
| Treasure Coast Research /ID# 161824 | Stuart | Florida | 34996 | — |
| Discovery Clinical Research /ID# 160891 | Sunrise | Florida | 33324 | — |
| Precision Clinical Research /ID# 165377 | Sunrise | Florida | 33351-7311 | — |
| GCP Clinical Research, LLC /ID# 164593 | Tampa | Florida | 33609-4044 | — |
| University of South Florida- Neuroscience Institute /ID# 160960 | Tampa | Florida | 33613 | — |
| Jedidiah Clinical Research /ID# 167114 | Tampa | Florida | 33617 | — |
| Virtus Research Consultants, LLC /ID# 160855 | Wellington | Florida | 33414 | — |
| Comprehensive Clinical Trials LLC /ID# 161479 | West Palm Beach | Florida | 33409 | — |
| Journey Medical Research Insti /ID# 160958 | Alpharetta | Georgia | 30005 | — |
| Paramount Research Solutions /ID# 161557 | Alpharetta | Georgia | 30005 | — |
| AGILE Clinical Research Trials /ID# 160941 | Atlanta | Georgia | 30328-5532 | — |
| Mount Vernon Clinical Res, LLC /ID# 161491 | Atlanta | Georgia | 30328 | — |
| Atlanta Women's Research Institute /ID# 160844 | Atlanta | Georgia | 30342 | — |
| Medisense Inc /ID# 161494 | Atlanta | Georgia | 30363 | — |
| Duplicate_Atlanta Gynecology Research Institute /ID# 160851 | Suwanee | Georgia | 30024-7159 | — |
| Bingham Memorial Hospital /ID# 201130 | Blackfoot | Idaho | 83221 | — |
| Leavitt Womens Healthcare /ID# 163419 | Idaho Falls | Idaho | 83404 | — |
| Womens Healthcare Assoc, DBA /ID# 160933 | Idaho Falls | Idaho | 83404 | — |
| Sonora Clinical Research /ID# 167610 | Meridian | Idaho | 83646-1144 | — |
| Asr, Llc /Id# 162179 | Nampa | Idaho | 83687 | — |
| Women's Health Practice, LLC /ID# 161553 | Champaign | Illinois | 61820 | — |
| Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118 | Chicago | Illinois | 60605-2168 | — |
| Duplicate_University of Chicago /ID# 162667 | Chicago | Illinois | 60637 | — |
| Alliance for Multispecialty Research, LLC /ID# 160932 | Oak Brook | Illinois | 60523 | — |
| Women's Health Advantage /ID# 161537 | Fort Wayne | Indiana | 46825 | — |
| Womens & Family Care, LLC dba /ID# 160890 | Shawnee Mission | Kansas | 66218 | — |
| Bluegrass Clinical Research /ID# 163485 | Louisville | Kentucky | 40291-1988 | — |
| Clinical Trials Management, LLC - Covington /ID# 160838 | Covington | Louisiana | 70433 | — |
| Clinical Trials Management, LLC - Covington /ID# 160893 | Covington | Louisiana | 70433 | — |
| Praetorian Pharmaceutical Research /ID# 161532 | Marrero | Louisiana | 70072 | — |
| Ochsner Baptist Medical Centre /ID# 161507 | New Orleans | Louisiana | 70115 | — |
| Women Under Study, LLC /ID# 163990 | New Orleans | Louisiana | 70125-1923 | — |
| Willis-Knighton Pediatric GI S /ID# 161534 | Shreveport | Louisiana | 71118 | — |
| Exordia Medical Research, Inc /ID# 160853 | Fall River | Massachusetts | 02723 | — |
| Duplicate_Great Lakes Research Group, Inc. /ID# 161511 | Bay City | Michigan | 48602 | — |
| Wayne State University /ID# 160944 | Detroit | Michigan | 48201-2013 | — |
| Valley OB-Gyn Clinic - Saginaw /ID# 203579 | Saginaw | Michigan | 48602-4323 | — |
| Saginaw Valley Med Res Group /ID# 160840 | Saginaw | Michigan | 48604 | — |
| Quad Clinical Research, LLC /ID# 200943 | St Louis | Missouri | 63109 | — |
| Excel Clinical Research /ID# 165588 | Las Vegas | Nevada | 89109 | — |
| Office of Edmond E. Pack, MD /ID# 162604 | Las Vegas | Nevada | 89113 | — |
| Private practice: Dr. Rex G. Mabey JR /ID# 160915 | Las Vegas | Nevada | 89128 | — |
| Jersey Shore University Medical Center /ID# 160916 | Neptune City | New Jersey | 07753-4859 | — |
| Lovelace Scientific Resources /ID# 163644 | Albuquerque | New Mexico | 87108 | — |
| Bosque Women's Care /ID# 162606 | Albuquerque | New Mexico | 87109 | — |
| SUNY Downstate Medical Center /ID# 160922 | Brooklyn | New York | 11203 | — |
| Duplicate_Northwell Health System - Manhasset /ID# 201058 | Manhasset | New York | 11030-3816 | — |
| Columbia Univ Medical Center /ID# 161519 | New York | New York | 10032-3725 | — |
| Hamburg Regional Gynecology Gr /ID# 161427 | Orchard Park | New York | 14127 | — |
| DJL Clinical Research, PLLC /ID# 161548 | Charlotte | North Carolina | 28211 | — |
| Carolina Women's Research and Wellness Center /ID# 160914 | Durham | North Carolina | 27713-7512 | — |
| Unified Women's Clinical Resea /ID# 163014 | Raleigh | North Carolina | 27607 | — |
| Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490 | Raleigh | North Carolina | 27612 | — |
| Unified Women's Clinical Resea /ID# 160957 | Winston-Salem | North Carolina | 27103 | — |
| Clinical Inquest Center Ltd /ID# 160892 | Beavercreek | Ohio | 45431-2573 | — |
| Duplicate_CTI Clinical Research Center /ID# 160942 | Cincinnati | Ohio | 45212 | — |
| Univ Hosp Cleveland /ID# 160953 | Cleveland | Ohio | 44106 | — |
| Central Ohio Clinical Research /ID# 201162 | Columbus | Ohio | 43213-3399 | — |
| Duplicate_Optimed Research /ID# 165600 | Columbus | Ohio | 43235 | — |
| Hilltop Obstetrics & Gynecology /ID# 203576 | Middletown | Ohio | 45005-5200 | — |
| University of Toledo /ID# 160923 | Toledo | Ohio | 43614 | — |
| Oregon Medical Research Center /ID# 161514 | Portland | Oregon | 97239 | — |
| OB/GYN Associates of Erie /ID# 161541 | Erie | Pennsylvania | 16507-1423 | — |
| Penn State University and Milton S. Hershey Medical Center /ID# 160896 | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania /ID# 160936 | Philadelphia | Pennsylvania | 19104-5502 | — |
| DUP_Thomas Jefferson University /ID# 200304 | Philadelphia | Pennsylvania | 19107 | — |
| Vista Clinical Research /ID# 160946 | Columbia | South Carolina | 29201 | — |
| VitaLink Research-Spartanburg /ID# 164592 | Spartanburg | South Carolina | 29303 | — |
| Duplicate_Chattanooga Medical Research /ID# 160885 | Chattanooga | Tennessee | 37404 | — |
| WR-ClinSearch /ID# 160887 | Chattanooga | Tennessee | 37421-1605 | — |
| The Jackson Clinic, PA /ID# 162496 | Jackson | Tennessee | 38305 | — |
| Research Memphis Associates, LLC /ID# 160939 | Memphis | Tennessee | 38119-3895 | — |
| OBGYN North /ID# 203580 | Austin | Texas | 78758-5444 | — |
| Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542 | Austin | Texas | 78758-5653 | — |
| Discovery Clinical Trials -HCWC /ID# 161543 | Dallas | Texas | 75230-2571 | — |
| Duplicate_The University of Texas Southwestern Medical Center /ID# 161496 | Dallas | Texas | 75390-8575 | — |
| Baylor Scott & White /ID# 161515 | Fort Worth | Texas | 76104-4110 | — |
| Willowbend Health and Wellness - Frisco /ID# 160954 | Frisco | Texas | 75035 | — |
| The Ob/Gyn Center /ID# 165928 | Houston | Texas | 77030 | — |
| Precision Research Institute, LLC /ID# 161554 | Houston | Texas | 77036 | — |
| The Woman's Hospital of Texas /ID# 160959 | Houston | Texas | 77054 | — |
| Centex Studies, Inc /ID# 163858 | Houston | Texas | 77058-2705 | — |
| Centex Studies, Inc. - Houston /ID# 160917 | Houston | Texas | 77058 | — |
| UAG Innovation Women Research, /ID# 167415 | Houston | Texas | 77074 | — |
| America's Adv. Wellness Center /ID# 167548 | Houston | Texas | 77080 | — |
| FMC Science /ID# 160886 | Lampasas | Texas | 76550 | — |
| Advances in Health, Inc. /ID# 160930 | Pearland | Texas | 77854 | — |
| ClinRx Research, LLC /ID# 201170 | Plano | Texas | 75024-5280 | — |
| Clinical Trials of Texas, Inc /ID# 161510 | San Antonio | Texas | 78229 | — |
| VIP Trials /ID# 161546 | San Antonio | Texas | 78230 | — |
| Houston Ctr for Clin Research /ID# 160837 | Sugar Land | Texas | 77479 | — |
| The Univ Texas HSC at Tyler /ID# 161533 | Tyler | Texas | 75708 | — |
| Center of Reproductive Medicine /ID# 162498 | Webster | Texas | 77598 | — |
| Univ of Virgnia Medical center /ID# 166283 | Charlottesville | Virginia | 22908-0816 | — |
| Eastern Virginia Med School /ID# 160856 | Norfolk | Virginia | 23507-1627 | — |
| Clinical Research Partners /ID# 160929 | North Chesterfield | Virginia | 23235 | — |
| Clinical Research Partners /ID# 160948 | North Chesterfield | Virginia | 23235 | — |
| Clinical Trials Virginia, Inc. /ID# 160943 | Richmond | Virginia | 23225 | — |
| Specialists for Women /ID# 201129 | Suffolk | Virginia | 23434-8151 | — |
| Tidewater Clinical Research /ID# 160949 | Virginia Beach | Virginia | 23456 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03271489, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2025 · Synced May 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03271489 live on ClinicalTrials.gov.