ClinicalTrials.gov record
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
ClinicalTrials.gov ID: NCT03213457
Public ClinicalTrials.gov record NCT03213457. 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 Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
Study identification
- NCT ID
- NCT03213457
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 681 participants
Conditions and interventions
Conditions
Interventions
- Estradiol/Norethindrone Acetate Drug
- Placebo for Elagolix Drug
- Elagolix Drug
- Placebo for E2/NETA Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 49 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
- Jul 7, 2017 (Actual)
- Primary completion
- Mar 27, 2020 (Actual)
- Completion
- Dec 6, 2023 (Actual)
- Last update posted
- Dec 20, 2024
2017 – 2023
United States locations
- U.S. sites
- 188
- U.S. states
- 37
- U.S. cities
- 143
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates /ID# 163087 | Birmingham | Alabama | 35205 | — |
| Alabama Clinical Therapeutics, LLC /ID# 145503 | Birmingham | Alabama | 35235-3430 | — |
| Alabama Clinical Therapeutics, LLC /ID# 151468 | Birmingham | Alabama | 35235-3430 | — |
| Southern Women's Specialists PC /ID# 148750 | Fairhope | Alabama | 36532-3029 | — |
| Women's Health Alliance of Mobile /ID# 150083 | Mobile | Alabama | 36604-1410 | — |
| University of South Alabama /ID# 148774 | Mobile | Alabama | 36604-3302 | — |
| Mobile, Ob-Gyn, P.C. /ID# 145364 | Mobile | Alabama | 36608 | — |
| Mesa Obstetricians and Gynecologists /ID# 147320 | Mesa | Arizona | 85209 | — |
| Arizona Research Assoc /ID# 161703 | Tucson | Arizona | 85712 | — |
| Eclipse Clinical Research /ID# 155600 | Tucson | Arizona | 85745 | — |
| Unity Health- Searcy Medical Center /ID# 203674 | Searcy | Arkansas | 72143-4802 | — |
| Core Healthcare Group /ID# 149321 | Cerritos | California | 90703 | — |
| HRC Fertility /ID# 154143 | Encino | California | 91436 | — |
| Glendale Adventist Medical Ctr /ID# 160530 | Glendale | California | 91206 | — |
| HCP Clinical Research LLC /ID# 152045 | Huntington Beach | California | 92646 | — |
| Alliance Research Centers /ID# 151240 | Irvine | California | 92612-1245 | — |
| Long Beach Clinical Trial Serv /ID# 152428 | Long Beach | California | 90806 | — |
| Olympia Clinical Trials /ID# 202325 | Los Angeles | California | 90036-4667 | — |
| California Medical Research As /ID# 154746 | Northridge | California | 91324 | — |
| Futura Research, Org /ID# 145406 | Norwalk | California | 90650 | — |
| Huntington Medical Foundation /ID# 154750 | Pasadena | California | 91105 | — |
| Northern California Research /ID# 159753 | Sacramento | California | 95821-2640 | — |
| Precision Research Institute - San Diego /ID# 152557 | San Diego | California | 92114-3643 | — |
| MD Strategies Research Centers /ID# 152429 | San Diego | California | 92119 | — |
| Alta California Medical Group /ID# 155706 | Simi Valley | California | 93065 | — |
| Downtown Womens Health Care /ID# 147955 | Denver | Colorado | 80209 | — |
| Advanced Women's Health Institute /ID# 145396 | Greenwood Village | Colorado | 80111 | — |
| Red Rocks OB/GYN /ID# 145325 | Lakewood | Colorado | 80228-1810 | — |
| The Women's Health Group - Thornton /ID# 203707 | Thornton | Colorado | 80229-4385 | — |
| James A. Simon, MD, PC /ID# 145480 | Washington D.C. | District of Columbia | 20036 | — |
| Helix Biomedics, LLC /ID# 147108 | Boynton Beach | Florida | 33436-6634 | — |
| Gulf Coast Research Group /ID# 162895 | Brandon | Florida | 33510 | — |
| Olympian Clinical Research /ID# 148167 | Clearwater | Florida | 33756 | — |
| Omega Research Maitland, LLC /ID# 145167 | DeBary | Florida | 32713-2260 | — |
| KO Clinical Research, LLC /ID# 145410 | Fort Lauderdale | Florida | 33316 | — |
| Clinical Physiology Associates /ID# 145237 | Fort Myers | Florida | 33912 | — |
| Solutions Through Adv Rch /ID# 148768 | Jacksonville | Florida | 32256 | — |
| Vida Clinical Research /ID# 150282 | Kissimmee | Florida | 34741-2345 | — |
| Axcess Medical Center /ID# 148169 | Loxahatchee Groves | Florida | 33470 | — |
| Genoma Research Group, Inc /ID# 152558 | Miami | Florida | 33165 | — |
| Vista Health Research LLC - Miami /ID# 151455 | Miami | Florida | 33176-1032 | — |
| Palmetto Professional Research /ID# 153838 | Miami | Florida | 33186-1309 | — |
| Precision Research Organization /ID# 145337 | Miami Lakes | Florida | 33016-1501 | — |
| Ocean Blue Medical Research Center, Inc /ID# 145514 | Miami Springs | Florida | 33166 | — |
| Salom Tangir, LLC /ID# 148739 | Miramar | Florida | 33027 | — |
| Suncoast Clinical Research /ID# 145484 | New Port Richey | Florida | 34652 | — |
| Oncova Clinical Research, Inc. /ID# 148175 | Saint Cloud | Florida | 34769 | — |
| Physician Care Clin. Res., LLC /ID# 145511 | Sarasota | Florida | 34239 | — |
| Meridien Research - St Petersburg /ID# 145345 | St. Petersburg | Florida | 33709-3113 | — |
| Treasure Coast Research /ID# 148174 | Stuart | Florida | 34996 | — |
| University of South Florida /ID# 145424 | Tampa | Florida | 33612 | — |
| Stedman Clinical Trials /ID# 152554 | Tampa | Florida | 33613 | — |
| Virtus Research Consultants, LLC /ID# 147101 | Wellington | Florida | 33414 | — |
| Comprehensive Clinical Trials /ID# 145148 | West Palm Beach | Florida | 33409 | — |
| Paramount Research Solutions /ID# 145226 | Alpharetta | Georgia | 30005 | — |
| Paramount Research Solutions /ID# 149320 | Alpharetta | Georgia | 30005 | — |
| Agile Clinical Research Trials /ID# 145494 | Atlanta | Georgia | 30328-5532 | — |
| Atlanta Women's Research Inst /ID# 145543 | Atlanta | Georgia | 30342 | — |
| Apogee Women's Health Inc. /ID# 145149 | College Park | Georgia | 30349 | — |
| Columbus Regional Research Ins /ID# 159752 | Columbus | Georgia | 31904 | — |
| Meridian Clinical Research, LLC /ID# 148176 | Savannah | Georgia | 31406-2675 | — |
| Atlanta Gynecology Research Institute /ID# 149322 | Suwanee | Georgia | 30024-7159 | — |
| Clinical Research Prime /ID# 161724 | Idaho Falls | Idaho | 83404 | — |
| Womens Healthcare Assoc, DBA /ID# 148744 | Idaho Falls | Idaho | 83404 | — |
| Advanced Clinical Research /ID# 147086 | Meridian | Idaho | 83642 | — |
| Sonora Clinical Research /ID# 145541 | Meridian | Idaho | 83646-1144 | — |
| Asr, Llc /Id# 161680 | Nampa | Idaho | 83687 | — |
| Women's Health Practice, LLC /ID# 145517 | Champaign | Illinois | 61820 | — |
| Affinity Clinical Research /ID# 151469 | Oak Brook | Illinois | 60523 | — |
| Center for Women's Research, Inc /ID# 145486 | Palos Heights | Illinois | 60463-1440 | — |
| The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459 | Park Ridge | Illinois | 60068 | — |
| American Health Network of Ind /ID# 167996 | Avon | Indiana | 46123-7960 | — |
| Women's Health Advantage /ID# 145495 | Fort Wayne | Indiana | 46825 | — |
| The Iowa Clinic /ID# 145409 | West Des Moines | Iowa | 50266 | — |
| Womens & Family Care, LLC dba /ID# 145211 | Shawnee Mission | Kansas | 66218 | — |
| PRN Professional Research Network of Kansas, LLC /ID# 151463 | Wichita | Kansas | 67205 | — |
| Cypress Medical Research Ctr /ID# 147159 | Wichita | Kansas | 67226 | — |
| University of Louisville /ID# 154751 | Louisville | Kentucky | 40202 | — |
| Bluegrass Clinical Research /ID# 151209 | Louisville | Kentucky | 40291-1988 | — |
| Clinical Trials Management, LLC - Covington /ID# 145220 | Covington | Louisiana | 70433 | — |
| Clinical Trials Management, LLC - Covington /ID# 145520 | Covington | Louisiana | 70433 | — |
| Horizon Research Group /ID# 148171 | Eunice | Louisiana | 70535 | — |
| Praetorian Pharmaceutical Res /ID# 145405 | Marrero | Louisiana | 70072 | — |
| Ochsner Baptist OB/GYN Clinic /ID# 147144 | New Orleans | Louisiana | 70115 | — |
| Women Under Study, LLC /ID# 151216 | New Orleans | Louisiana | 70125-1923 | — |
| Women's Health Clinic /ID# 155707 | Shreveport | Louisiana | 71118-3133 | — |
| Omni Fertility and Laser Insti /ID# 145532 | Shreveport | Louisiana | 71118 | — |
| Eastern Maine Medical Center /ID# 161681 | Bangor | Maine | 04401 | — |
| Univ Maryland School Medicine /ID# 151739 | Baltimore | Maryland | 21201 | — |
| Baltimore Suburban Health /ID# 147164 | Baltimore | Maryland | 21208 | — |
| Continental Clinical Solutions /ID# 152041 | Towson | Maryland | 21204 | — |
| NECCR Fall River LLC /ID# 145329 | Fall River | Massachusetts | 02720-2972 | — |
| Genesis Clinical Research - Fall River /ID# 148573 | Fall River | Massachusetts | 02723 | — |
| ClinSite, LLC /ID# 145314 | Ann Arbor | Michigan | 48105 | — |
| Great Lakes Research Group, Inc. /ID# 145308 | Bay City | Michigan | 48602 | — |
| Saginaw Valley Med Res Group /ID# 145527 | Saginaw | Michigan | 48604 | — |
| Wayne State University Physician Group - Southfield /ID# 145431 | Southfield | Michigan | 48034 | — |
| Prism Research /ID# 159751 | Saint Paul | Minnesota | 55114 | — |
| Womens Clinic of Lincoln, P.C. /ID# 145366 | Lincoln | Nebraska | 68510 | — |
| Accent Clinical Trials /ID# 147109 | Las Vegas | Nevada | 89106-4017 | — |
| Office of Edmond E. Pack, MD /ID# 148747 | Las Vegas | Nevada | 89113 | — |
| R. Garn Mabey Jr, MD Chartered /ID# 145361 | Las Vegas | Nevada | 89128 | — |
| Jersey Shore University Medical Center /ID# 148756 | Neptune City | New Jersey | 07753-4859 | — |
| Rutgers Robert Wood Johnson /ID# 152858 | New Brunswick | New Jersey | 08901 | — |
| St. Joseph's Regional Medical /ID# 157759 | Totowa | New Jersey | 07512 | — |
| Albuquerque Clinical Trials, Inc /ID# 154747 | Albuquerque | New Mexico | 87102 | — |
| Bosque Women's Care /ID# 147084 | Albuquerque | New Mexico | 87109 | — |
| SUNY Downstate Medical Center /ID# 148749 | Brooklyn | New York | 11203 | — |
| Scott Research Inc. /ID# 161704 | Laurelton | New York | 11413 | — |
| Manhattan Medical Research /ID# 145175 | New York | New York | 10016-6023 | — |
| Columbia Univ Medical Center /ID# 145334 | New York | New York | 10032-3725 | — |
| Hamburg Regional Gynecology Gr /ID# 161705 | Orchard Park | New York | 14127 | — |
| OB.GYN Associates of WNY /ID# 161665 | West Seneca | New York | 14224 | — |
| PMG Research of Charlotte /ID# 145432 | Charlotte | North Carolina | 28209 | — |
| DJL Clinical Research, PLLC /ID# 154679 | Charlotte | North Carolina | 28210-8508 | — |
| Carolina Women's Research and Wellness Center /ID# 145356 | Durham | North Carolina | 27713 | — |
| Unified Women's Clinical Research-Greensboro /ID# 155543 | Greensboro | North Carolina | 27408 | — |
| Pinewest Ob-Gyn, Inc. /ID# 151743 | High Point | North Carolina | 27262 | — |
| Eastern Carolina Women's Centr /ID# 145386 | New Bern | North Carolina | 28562 | — |
| Unified Women's Clinical Resea /ID# 145353 | Raleigh | North Carolina | 27607 | — |
| PMG Research of Wilmington /ID# 152555 | Wilmington | North Carolina | 28401-6638 | — |
| Trinity Health Center Town /ID# 147102 | Minot | North Dakota | 58701 | — |
| Clinical Inquest Center Ltd /ID# 147107 | Beavercreek | Ohio | 45431-2573 | — |
| CTI Clinical Research Center /ID# 145428 | Cincinnati | Ohio | 45212 | — |
| The Christ Hospital /ID# 149244 | Cincinnati | Ohio | 45219 | — |
| University of Cincinnati /ID# 145496 | Cincinnati | Ohio | 45267-0585 | — |
| Univ Hosp Cleveland /ID# 148741 | Cleveland | Ohio | 44106 | — |
| The Ohio State University /ID# 145444 | Columbus | Ohio | 43210-1257 | — |
| Aventiv Research, Inc. /ID# 145492 | Columbus | Ohio | 43213 | — |
| Aventiv Research, Inc. /ID# 162896 | Columbus | Ohio | 43213 | — |
| Wright State University & CTRA /ID# 145512 | Fairborn | Ohio | 45324 | — |
| University of Toledo /ID# 145403 | Toledo | Ohio | 43614 | — |
| Oregon Health and Science University /ID# 155705 | Portland | Oregon | 97239 | — |
| Main Line Fertility Center /ID# 150099 | Bryn Mawr | Pennsylvania | 19010 | — |
| OB/GYN Associates of Erie /ID# 157935 | Erie | Pennsylvania | 16507-1423 | — |
| Penn State University and Milton S. Hershey Medical Center /ID# 145231 | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania /ID# 145470 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Drexel Univ College of Med /ID# 149789 | Philadelphia | Pennsylvania | 19129 | — |
| Frontier Clinical Research /ID# 162091 | Smithfield | Pennsylvania | 15478 | — |
| Vista Clinical Research /ID# 148767 | Columbia | South Carolina | 29201 | — |
| University Medical Group /ID# 148777 | Greenville | South Carolina | 29605 | — |
| Venus Gynecology, LLC /ID# 145336 | Myrtle Beach | South Carolina | 29572 | — |
| James T. Martin, Jr., MD., Obs /ID# 148755 | North Charleston | South Carolina | 29406 | — |
| Palmetto Clinical Research /ID# 150992 | Summerville | South Carolina | 29485-7539 | — |
| Brown Clinic, PLLP /ID# 154372 | Watertown | South Dakota | 57201 | — |
| Holston Medical Group /ID# 145449 | Bristol | Tennessee | 37620-7346 | — |
| Chattanooga Medical Research /ID# 145184 | Chattanooga | Tennessee | 37404 | — |
| WR-ClinSearch /ID# 145205 | Chattanooga | Tennessee | 37421-1605 | — |
| The Jackson Clinic, PA /ID# 145303 | Jackson | Tennessee | 38305 | — |
| Research Memphis Associates, LLC /ID# 150100 | Memphis | Tennessee | 38119-3895 | — |
| Access Clinical Trials, Inc. /ID# 145224 | Nashville | Tennessee | 37203 | — |
| Lotus Gynecology /ID# 148479 | Austin | Texas | 78703-1448 | — |
| AA (Austin Area) ObGyn PLLC /ID# 205696 | Austin | Texas | 78758-5653 | — |
| Sirius Clinical Research, LLC /ID# 154749 | Austin | Texas | 78759 | — |
| Gadolin Research, LLC /ID# 201383 | Beaumont | Texas | 77702-1100 | — |
| Center for Assisted Reprod. /ID# 154748 | Bedford | Texas | 76022 | — |
| Texas Health Presbyterian Hosp /ID# 150098 | Dallas | Texas | 75231 | — |
| UT Southwestern Medical Center /ID# 145201 | Dallas | Texas | 75390-7208 | — |
| Baylor Scott & White /ID# 170430 | Fort Worth | Texas | 76104-4110 | — |
| Signature Gyn Services /ID# 145534 | Fort Worth | Texas | 76104 | — |
| Willowbend Health and Wellness - Frisco /ID# 145245 | Frisco | Texas | 75035 | — |
| Next Innovative Clinical Research /ID# 203863 | Houston | Texas | 77004-6031 | — |
| Advances in Health, Inc. /ID# 145425 | Houston | Texas | 77030 | — |
| Houston Methodist Hospital /ID# 170586 | Houston | Texas | 77030 | — |
| Precision Research Institute - Houston /ID# 154370 | Houston | Texas | 77036 | — |
| The Woman's Hospital of Texas /ID# 145316 | Houston | Texas | 77054 | — |
| Centex Studies, Inc /ID# 148776 | Houston | Texas | 77058-2705 | — |
| FMC Science /ID# 150981 | Lampasas | Texas | 76550 | — |
| Clinical Trials of Texas, Inc /ID# 147100 | San Antonio | Texas | 78229 | — |
| VIP Trials /ID# 151745 | San Antonio | Texas | 78230 | — |
| Discovery Clinical Trials-San Antonio /ID# 145363 | San Antonio | Texas | 78258 | — |
| Houston Ctr for Clin Research /ID# 148799 | Sugar Land | Texas | 77479 | — |
| Center of Reproductive Medicin /ID# 145467 | Webster | Texas | 77598 | — |
| Corner Canyon Obstetrics and G /ID# 145519 | Draper | Utah | 84020 | — |
| Tanner Clinic /ID# 148786 | Layton | Utah | 84041 | — |
| Revere Health /ID# 145540 | Pleasant Grove | Utah | 84062 | — |
| Southampton Women's Health /ID# 151691 | Franklin | Virginia | 23851 | — |
| Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477 | Newport News | Virginia | 23606 | — |
| Clinical Research Partners, LL /ID# 145392 | North Chesterfield | Virginia | 23235-4722 | — |
| Clinical Research Partners, LL /ID# 145416 | North Chesterfield | Virginia | 23235-4722 | — |
| Clinical Trials Virginia, Inc. /ID# 145430 | Richmond | Virginia | 23225 | — |
| Alliance Womens Health /ID# 148770 | Richmond | Virginia | 23226-1930 | — |
| Tidewater Clinical Research /ID# 145397 | Virginia Beach | Virginia | 23456 | — |
| Clinical Research Adv, Inc. /ID# 149257 | Puyallup | Washington | 98372 | — |
| Virginia Mason Medical Center /ID# 145387 | Seattle | Washington | 98101 | — |
| Seattle Women's Health, Research, Gynecology /ID# 145341 | Seattle | Washington | 98105 | — |
| North Spokane Women's Health /ID# 145382 | Spokane | Washington | 99207 | — |
| Madigan Army Medical Center /ID# 145186 | Tacoma | Washington | 98431 | — |
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 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03213457, 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 Dec 20, 2024 · Synced Oct 21, 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 NCT03213457 live on ClinicalTrials.gov.