ClinicalTrials.gov record
Efficacy and Safety 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: NCT02654054
Public ClinicalTrials.gov record NCT02654054. 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 3 Study to Evaluate the Efficacy and 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
- NCT02654054
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- AbbVie
- Industry
- Enrollment
- 413 participants
Conditions and interventions
Conditions
Interventions
- Elagolix Drug
- Placebo for Estradiol/Norethindrone Acetate Drug
- Estradiol/Norethindrone Acetate Drug
- Placebo for Elagolix Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 51 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
- Dec 21, 2015
- Primary completion
- Jan 17, 2018
- Completion
- Dec 11, 2018
- Last update posted
- Jun 28, 2020
2015 – 2018
United States locations
- U.S. sites
- 92
- U.S. states
- 29
- U.S. cities
- 82
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Summers, Birmingham, AL /ID# 139684 | Birmingham | Alabama | 35235 | — |
| University of South Alabama /ID# 148763 | Mobile | Alabama | 36604-3302 | — |
| WCCT Global, LLC /ID# 145666 | Costa Mesa | California | 92626 | — |
| American Clinical Trials /ID# 147374 | Hawaiian Gardens | California | 90716 | — |
| Grossmont Ctr Clin Research /ID# 144011 | La Mesa | California | 91942 | — |
| Long Beach Clinical Trial Serv /ID# 152424 | Long Beach | California | 90806 | — |
| National Research Institute /ID# 151629 | Los Angeles | California | 90057 | — |
| University of California, Los Angeles /ID# 144107 | Los Angeles | California | 90095 | — |
| Beach OBGYN Medical Group /ID# 151414 | Newport Beach | California | 92663-3657 | — |
| Advanced RX Clinical Research /ID# 149168 | Westminster | California | 92683-4567 | — |
| Bluebird Clinical Trials, LLC /ID# 144843 | Colorado Springs | Colorado | 80923 | — |
| Advanced Women's Health Institution /ID# 144108 | Greenwood Village | Colorado | 80111 | — |
| Medstar Health Research Institute /ID# 145933 | Washington D.C. | District of Columbia | 20010 | — |
| James A. Simon, MD, PC /ID# 139675 | Washington D.C. | District of Columbia | 20036 | — |
| Helix Biomedics, LLC /ID# 147114 | Boynton Beach | Florida | 33436-6634 | — |
| Brandon Premier Health Care, PA /ID# 153130 | Brandon | Florida | 33510-3107 | — |
| Florida Clin Res Group /ID# 139811 | Ckearwater | Florida | 33759 | — |
| Universal Clinical Research A /ID# 139742 | Doral | Florida | 33166 | — |
| Clinical Physiology Associates /ID# 139736 | Fort Myers | Florida | 33912 | — |
| Meridien Research /ID# 139663 | Kenneth City | Florida | 33709-3113 | — |
| Altus Research, Inc /ID# 139662 | Lake Worth | Florida | 33461 | — |
| South Florida Wellness & Clinic /ID# 143558 | Margate | Florida | 33063 | — |
| LCC Medical Research Institute /ID# 143551 | Miami | Florida | 33126 | — |
| Healthcare Clinical Data, Inc /ID# 139650 | Miami | Florida | 33161 | — |
| Ocean Blue Med Research Ctr /ID# 139826 | Miami | Florida | 33166 | — |
| Salom Tangir, LLC /ID# 151732 | Miramar | Florida | 33027 | — |
| Advanced Research Institute /ID# 143554 | New Port Richey | Florida | 34653 | — |
| Clinical Associates of Orlando /ID# 148123 | Orlando | Florida | 32806 | — |
| Omega Research Consultants /ID# 139648 | Orlando | Florida | 32810 | — |
| Unified Womens Clin Research /ID# 145169 | Panama City | Florida | 32045 | — |
| Comprehensive Clinical Trials /ID# 139644 | West Palm Beach | Florida | 33409 | — |
| Atlanta Medical Research Insti /ID# 147117 | Alpharetta | Georgia | 30005-4419 | — |
| Paramount Research Solutions /ID# 139645 | Alpharetta | Georgia | 30005 | — |
| Agile Clinical Research Trials /ID# 143563 | Atlanta | Georgia | 30328 | — |
| Perimeter Inst Clinical Resear /ID# 148298 | Atlanta | Georgia | 30338 | — |
| Masters of Clinical Research, Inc. /ID# 139658 | Augusta | Georgia | 30909 | — |
| Fellows Research Alliance, Inc /ID# 139655 | Savannah | Georgia | 31406 | — |
| Boise Family Medical Center /ID# 139844 | Boise | Idaho | 83709 | — |
| Women's Health Practice, LLC /ID# 143569 | Champaign | Illinois | 61820 | — |
| Great Lakes Clinical Trials /ID# 148135 | Chicago | Illinois | 60640 | — |
| Affinity Clinical Research /ID# 150980 | Oak Brook | Illinois | 60523 | — |
| American Health Network of IN /ID# 139822 | Avon | Indiana | 46123 | — |
| GTC Research /ID# 141854 | Kansas City | Kansas | 66218 | — |
| Cypress Medical Research Ctr /ID# 147116 | Wichita | Kansas | 67226 | — |
| Research Integrity, LLC /ID# 139727 | Owensboro | Kentucky | 42303-1089 | — |
| Clinical Trials Management, LLC - Covington /ID# 139651 | Covington | Louisiana | 70433 | — |
| Ochsner Baptist Medical Center /ID# 139740 | New Orleans | Louisiana | 70115 | — |
| Omni Fertility and Laser Insti /ID# 139836 | Shreveport | Louisiana | 71118 | — |
| Capital Women's Care /ID# 144109 | Frederick | Maryland | 21708 | — |
| Genesis Clinical Research - Fall River /ID# 148449 | Fall River | Massachusetts | 02723 | — |
| Great Lakes Research Group,Inc /ID# 139659 | Bay City | Michigan | 48706 | — |
| Grand Rapids Womens Health /ID# 139705 | Grand Rapids | Michigan | 49503 | — |
| Wayne State University Physician Group - Southfield /ID# 139802 | Southfield | Michigan | 48034 | — |
| Office of Edmond E. Pack, MD /ID# 139792 | Las Vegas | Nevada | 89113 | — |
| Mabey, Las Vegas, NV /ID# 148138 | Las Vegas | Nevada | 89128 | — |
| Lawrence OB/GYN /ID# 143567 | Lawrenceville | New Jersey | 08648 | — |
| Bosque Women's Care /ID# 145934 | Albuquerque | New Mexico | 87109 | — |
| Manhattan Medical Research /ID# 144471 | New York | New York | 10016-6023 | — |
| Cwrwc /Id# 139664 | Durham | North Carolina | 27713 | — |
| Unified Women's Clinical Research-Greensboro /ID# 139829 | Greensboro | North Carolina | 27408 | — |
| Unified Women's Clinical Resea /ID# 139774 | Raleigh | North Carolina | 27607 | — |
| PMG Research of Wilmington LLC /ID# 152563 | Wilmington | North Carolina | 28401 | — |
| Unified Women's Clinical Resea /ID# 144721 | Winston-Salem | North Carolina | 27103 | — |
| University of Cincinnati /ID# 139820 | Cincinnati | Ohio | 45267-0585 | — |
| Univ Hosp Cleveland /ID# 139741 | Cleveland | Ohio | 44106 | — |
| Complete Healthcare for Women /ID# 139673 | Columbus | Ohio | 43231 | — |
| Miami Valley Hospital /ID# 144430 | Dayton | Ohio | 45409 | — |
| University of Toledo /ID# 139787 | Toledo | Ohio | 43614 | — |
| Legacy Medical Group-Portland /ID# 148807 | Portland | Oregon | 97210 | — |
| Main Line Fertility Center /ID# 150295 | Bryn Mawr | Pennsylvania | 19010 | — |
| Penn State University and Milton S. Hershey Medical Center /ID# 139733 | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University /ID# 139812 | Philadelphia | Pennsylvania | 19107-4414 | — |
| Temple University Hospital /ID# 151429 | Philadelphia | Pennsylvania | 19140 | — |
| Clinical Trials Research Svcs /ID# 139707 | Pittsburgh | Pennsylvania | 15206 | — |
| Medical University of South Carolina /ID# 148754 | Charleston | South Carolina | 29425 | — |
| Vista Clinical Research /ID# 139797 | Columbia | South Carolina | 29201 | — |
| WR-ClinSearch /ID# 143538 | Chattanooga | Tennessee | 37421-1605 | — |
| Research Memphis Associates, LLC /ID# 139674 | Memphis | Tennessee | 38119-3895 | — |
| Access Clinical Trials, Inc. /ID# 139730 | Nashville | Tennessee | 37203 | — |
| UT Southwestern Medical Center /ID# 143537 | Dallas | Texas | 75390-7208 | — |
| Advances in Health, Inc. /ID# 139672 | Houston | Texas | 77030 | — |
| Victorium Clinical Research /ID# 149630 | San Antonio | Texas | 78230 | — |
| Discovery Clinical Trials-San Antonio /ID# 139776 | San Antonio | Texas | 78258 | — |
| Houston Ctr for Clin Research /ID# 149149 | Sugar Land | Texas | 77479 | — |
| Center of Reproductive Medicin /ID# 139813 | Webster | Texas | 77598 | — |
| Eastern Virginia Med School /ID# 139647 | Norfolk | Virginia | 23507-1627 | — |
| Clinical Research Partners, LL /ID# 143999 | North Chesterfield | Virginia | 23235-4722 | — |
| Clinical Trials Virginia, Inc. /ID# 139801 | Richmond | Virginia | 23225 | — |
| Emerson Clinical Research /ID# 147373 | Vienna | Virginia | 22182 | — |
| Seattle Women's Health, Research, Gynecology /ID# 139768 | Seattle | Washington | 98105 | — |
| Premier Clinical Research /ID# 148145 | Spokane | Washington | 99202 | — |
| Froedtert and Medical College /ID# 143566 | Milwaukee | Wisconsin | 53226-3522 | — |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02654054, 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 Jun 28, 2020 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02654054 live on ClinicalTrials.gov.