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 (Replicate Study)
ClinicalTrials.gov ID: NCT02691494
Public ClinicalTrials.gov record NCT02691494. 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Study identification
- NCT ID
- NCT02691494
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 378 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
- Feb 3, 2016 (Actual)
- Primary completion
- Feb 14, 2018 (Actual)
- Completion
- Jan 23, 2019 (Actual)
- Last update posted
- Jul 13, 2021
2016 – 2019
United States locations
- U.S. sites
- 103
- U.S. states
- 26
- U.S. cities
- 92
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC /ID# 152258 | Birmingham | Alabama | 35235-3430 | — |
| Choice Research, LLC /ID# 150988 | Dothan | Alabama | 36303 | — |
| Brown, Pearson, Guepet Gynecology /ID# 151020 | Fairhope | Alabama | 36532 | — |
| Mobile, Ob-Gyn, P.C. /ID# 144294 | Mobile | Alabama | 36608 | — |
| Mesa Obstetricians and Gynecol /ID# 149139 | Mesa | Arizona | 85209 | — |
| Visions Clinical Research-Tucs /ID# 151017 | Tucson | Arizona | 85712 | — |
| Core Healthcare Group /ID# 151016 | Cerritos | California | 90703 | — |
| Diagnamics Inc. /ID# 152469 | Encinitas | California | 92024 | — |
| HCP Clinical Research LLC /ID# 154434 | Huntington Beach | California | 92646 | — |
| Alliance Research Centers /ID# 149752 | Laguna Hills | California | 92653-3621 | — |
| University of California, Los Angeles /ID# 149760 | Los Angeles | California | 90095 | — |
| Futura Research, Inc. /ID# 149759 | Norwalk | California | 90650 | — |
| Farid Yasharpour MD Medical Co /ID# 149770 | San Fernando | California | 91340 | — |
| Clinical Trial Investigators /ID# 152470 | Tustin | California | 92780 | — |
| Bayview Research Group LLC /ID# 153799 | Valley Village | California | 91607 | — |
| Emerson Clinical Research Inst /ID# 152348 | Washington D.C. | District of Columbia | 20011 | — |
| Ideal Clinical Research Inc. /ID# 149757 | Aventura | Florida | 33180 | — |
| Seffner Premier Health Care, P /ID# 167480 | Brandon | Florida | 33510 | — |
| Olympian Clinical Research /ID# 149756 | Clearwater | Florida | 33756 | — |
| KO Clinical Research, LLC /ID# 144299 | Fort Lauderdale | Florida | 33316 | — |
| University of Florida /ID# 149751 | Gainesville | Florida | 32610 | — |
| Solutions Through Adv Rch /ID# 151021 | Jacksonville | Florida | 32256 | — |
| Meridien Research /ID# 167100 | Kenneth City | Florida | 33709-3113 | — |
| Invictus Clinical Research Group,LLC /ID# 141859 | Miami | Florida | 33144 | — |
| Precision Research Org, LLC /ID# 144335 | Miami Lakes | Florida | 33016-1501 | — |
| Suncoast Clinical Research /ID# 149765 | New Port Richey | Florida | 34652 | — |
| All Wmns HC of West Broward /ID# 144298 | Plantation | Florida | 33324 | — |
| Oncova Clinical Research, Inc. /ID# 149764 | Saint Cloud | Florida | 34769 | — |
| Physician Care Clin. Res., LLC /ID# 149766 | Sarasota | Florida | 34239 | — |
| Qps-Mra, Llc /Id# 144325 | South Miami | Florida | 33143 | — |
| Martin Health System Center /ID# 152263 | Stuart | Florida | 34994 | — |
| University of South Florida /ID# 149754 | Tampa | Florida | 33612 | — |
| Axcess Medical Research /ID# 149769 | Wellington | Florida | 33414 | — |
| Virtus Research Consultant,LLC /ID# 144296 | Wellington | Florida | 33414 | — |
| Paramount Research Solutions /ID# 149291 | Alpharetta | Georgia | 30005 | — |
| Agile Clinical Research Trials /ID# 167074 | Atlanta | Georgia | 30328 | — |
| Mount Vernon Clinical Res, LLC /ID# 144297 | Atlanta | Georgia | 30328 | — |
| Atlanta Women's Research Inst /ID# 144303 | Atlanta | Georgia | 30342 | — |
| Masters of Clinical Research, Inc. /ID# 167400 | Augusta | Georgia | 30909 | — |
| Georgia Regents University /ID# 144295 | Augusta | Georgia | 30912 | — |
| Meridian Clinical Research, LLC /ID# 149144 | Savannah | Georgia | 31406-2675 | — |
| Gyn-Care, Inc. /ID# 149341 | Smyrna | Georgia | 30080 | — |
| Atlanta Gynecology Research Institute /ID# 151014 | Suwanee | Georgia | 30024-7159 | — |
| Womens Healthcare Assoc, DBA /ID# 149762 | Idaho Falls | Idaho | 83404 | — |
| Advanced Clinical Research /ID# 149767 | Meridian | Idaho | 83642 | — |
| University of Chicago /ID# 152257 | Chicago | Illinois | 60637-1443 | — |
| Affinity Clinical Research /ID# 167119 | Oak Brook | Illinois | 60523 | — |
| Center for Women's Research, Inc /ID# 144300 | Palos Heights | Illinois | 60463-1440 | — |
| Women's Health Advantage /ID# 144301 | Fort Wayne | Indiana | 46825 | — |
| The Iowa Clinic /ID# 150105 | West Des Moines | Iowa | 50266 | — |
| PRN Professional Research Network of Kansas, LLC /ID# 152265 | Wichita | Kansas | 67205 | — |
| Bluegrass Clinical Research /ID# 150103 | Louisville | Kentucky | 40291 | — |
| Clinical Trials Management, LLC - Covington /ID# 144314 | Covington | Louisiana | 70433 | — |
| Women Under Study, LLC /ID# 144312 | New Orleans | Louisiana | 70125-1923 | — |
| Baltimore Suburban Health /ID# 154638 | Baltimore | Maryland | 21208 | — |
| Womens Health Center /ID# 154209 | Glen Burnie | Maryland | 21063 | — |
| Maryland Ctr for Sexual Health /ID# 149778 | Lutherville | Maryland | 21093 | — |
| NECCR Fall River LLC /ID# 149584 | Fall River | Massachusetts | 02720-2972 | — |
| Saginaw Valley Med Res Group /ID# 149768 | Saginaw | Michigan | 48604 | — |
| Accent Clinical Trials /ID# 149753 | Las Vegas | Nevada | 89106-4017 | — |
| Jersey Shore University Medical Center /ID# 149779 | Neptune City | New Jersey | 07753-4859 | — |
| Rowan University SOM /ID# 152697 | Stratford | New Jersey | 08084 | — |
| SUNY Downstate Medical Center /ID# 144311 | Brooklyn | New York | 11203 | — |
| Manhattan Medical Research /ID# 167077 | New York | New York | 10016-6023 | — |
| Weill Cornell Medicine /ID# 149585 | New York | New York | 10032-3725 | — |
| Montefiore Medical Center /ID# 149582 | The Bronx | New York | 10461 | — |
| Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587 | Fayetteville | North Carolina | 28304 | — |
| Unified Women's Clinical Research-Greensboro /ID# 149588 | Greensboro | North Carolina | 27408 | — |
| Pinewest Ob-Gyn, Inc. /ID# 145671 | High Point | North Carolina | 27262 | — |
| Eastern Carolina Women's Centr /ID# 144309 | New Bern | North Carolina | 28562 | — |
| Wake Research Associates, LLC /ID# 144307 | Raleigh | North Carolina | 27612 | — |
| Clinical Inquest Center Ltd /ID# 148728 | Beavercreek | Ohio | 45432 | — |
| CTI Clinical Research Center /ID# 149761 | Cincinnati | Ohio | 45212 | — |
| The Christ Hospital /ID# 150104 | Cincinnati | Ohio | 45219 | — |
| Alpha Research Associates LLC /ID# 152471 | Dayton | Ohio | 45417 | — |
| Comprehensive Womens Care /ID# 144306 | Westerville | Ohio | 43081 | — |
| Family Medical Associates /ID# 145668 | Levittown | Pennsylvania | 19056 | — |
| University of Pennsylvania /ID# 149586 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Clinical Research of Philadelphia, LLC /ID# 151015 | Philadelphia | Pennsylvania | 19114 | — |
| Reading Hosp Clncl Trials Ofc /ID# 149583 | West Reading | Pennsylvania | 19611 | — |
| Holston Medical Group /ID# 149763 | Bristol | Tennessee | 37620-7346 | — |
| Chattanooga Medical Research /ID# 145667 | Chattanooga | Tennessee | 37404 | — |
| Chattanooga Women for Women /ID# 167051 | Hixson | Tennessee | 37343-3992 | — |
| The Jackson Clinic, PA /ID# 145670 | Jackson | Tennessee | 38305 | — |
| The Womens Physician Group /ID# 144317 | Memphis | Tennessee | 38104 | — |
| Access Clinical Trials, Inc. /ID# 167333 | Nashville | Tennessee | 37203 | — |
| Lotus Gynecology /ID# 149140 | Austin | Texas | 78703-1448 | — |
| Inquest Clinical Research /ID# 149755 | Baytown | Texas | 77521-2415 | — |
| Texas Health Presbyterian Hosp /ID# 149142 | Dallas | Texas | 75231 | — |
| Baylor College of Medicine /ID# 149141 | Houston | Texas | 77030-3411 | — |
| The Woman's Hospital of Texas /ID# 144319 | Houston | Texas | 77054 | — |
| Centex Studies, Inc. - Houston /ID# 150106 | Houston | Texas | 77058 | — |
| BI Research Center /ID# 149143 | Houston | Texas | 77084 | — |
| FMC Science /ID# 151802 | Lampasas | Texas | 76550 | — |
| Willowbend Health and Wellness /ID# 144318 | Plano | Texas | 75035 | — |
| Clinical Trials of Texas,Inc. /ID# 144322 | San Antonio | Texas | 78229 | — |
| Center of Reproductive Medicin /ID# 167235 | Webster | Texas | 77598 | — |
| Southampton Women's Health /ID# 152325 | Franklin | Virginia | 23851 | — |
| Tidewater Physicians for Women /ID# 144321 | Norfolk | Virginia | 23502 | — |
| Clinical Research Partners, LLC /ID# 144310 | Richmond | Virginia | 23220-4459 | — |
| Alliance Womens Health /ID# 152468 | Richmond | Virginia | 23226-1930 | — |
| Zain Research /ID# 151018 | Richland | Washington | 99352 | — |
| Virginia Mason Medical Center /ID# 149758 | Seattle | Washington | 98101 | — |
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 NCT02691494, 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 13, 2021 · Synced Oct 20, 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 public registry record, listed eligibility criteria, and available contact information for NCT02691494 live on ClinicalTrials.gov.