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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03271489
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 478 participants
Conditions and interventions
Conditions
Interventions
- Elagolix Drug
- Estradiol /norethindrone acetate (E2/NETA) Drug
- E2/NETA Placebo Other
- Elagolix Placebo Other
Drug · Other
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 13, 2017 (Actual)
- Primary completion
- Jun 28, 2024 (Actual)
- Completion
- Jun 28, 2024 (Actual)
- Last update posted
- Jul 22, 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 22, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03271489 live on ClinicalTrials.gov.