ClinicalTrials.gov record
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
ClinicalTrials.gov ID: NCT02925494
Public ClinicalTrials.gov record NCT02925494. 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
Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
Study identification
- NCT ID
- NCT02925494
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 433 participants
Conditions and interventions
Conditions
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
- Sep 14, 2016 (Actual)
- Primary completion
- May 7, 2018 (Actual)
- Completion
- Mar 22, 2019 (Actual)
- Last update posted
- Jul 13, 2021
2016 – 2019
United States locations
- U.S. sites
- 121
- U.S. states
- 27
- U.S. cities
- 93
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC /ID# 153217 | Birmingham | Alabama | 35235-3430 | — |
| Alabama Clinical Therapeutics, LLC /ID# 153336 | Birmingham | Alabama | 35235-3430 | — |
| Choice Research, LLC /ID# 153492 | Dothan | Alabama | 36303 | — |
| Brown, Pearson, Guepet Gynecology /ID# 153278 | Fairhope | Alabama | 36532 | — |
| University of South Alabama /ID# 153415 | Mobile | Alabama | 36604-3302 | — |
| Mobile, Ob-Gyn, P.C. /ID# 153442 | Mobile | Alabama | 36608 | — |
| Mesa Obstetricians and Gynecol /ID# 153269 | Mesa | Arizona | 85209 | — |
| Core Healthcare Group /ID# 153282 | Cerritos | California | 90703 | — |
| Diagnamics Inc. /ID# 153347 | Encinitas | California | 92024 | — |
| Grossmont Ctr Clin Research /ID# 153324 | La Mesa | California | 91942 | — |
| Futura Research, Inc. /ID# 153345 | Norwalk | California | 90650 | — |
| Farid Yasharpour MD Medical Co /ID# 153482 | San Fernando | California | 91340 | — |
| Advanced Women's Health Institution /ID# 153401 | Greenwood Village | Colorado | 80111 | — |
| Medstar Health Research Institute /ID# 153321 | Washington D.C. | District of Columbia | 20010 | — |
| Emerson Clinical Research Inst /ID# 162755 | Washington D.C. | District of Columbia | 20011 | — |
| James A. Simon, MD, PC /ID# 153323 | Washington D.C. | District of Columbia | 20036 | — |
| Helix Biomedics, LLC /ID# 153440 | Boynton Beach | Florida | 33436-6634 | — |
| Brandon Premier Health Care, PA /ID# 165791 | Brandon | Florida | 33510-3107 | — |
| Florida Fertility Institute /ID# 153308 | Clearwater | Florida | 33759 | — |
| Omega Research Consultants, LLC /ID# 153381 | DeBary | Florida | 32713-2260 | — |
| KO Clinical Research, LLC /ID# 153198 | Fort Lauderdale | Florida | 33316 | — |
| Clinical Physiology Assoc. /ID# 153444 | Fort Myers | Florida | 33916 | — |
| Solutions Through Adv Rch /ID# 153283 | Jacksonville | Florida | 32256 | — |
| Meridien Research /ID# 153310 | Kenneth City | Florida | 33709-3113 | — |
| Altus Research, Inc /ID# 153307 | Lake Worth | Florida | 33461 | — |
| South Florida Wellness & Clinic /ID# 153420 | Margate | Florida | 33063 | — |
| LCC Medical Research Institute /ID# 153296 | Miami | Florida | 33126 | — |
| Invictus Clinical Research Group,LLC /ID# 153196 | Miami | Florida | 33144 | — |
| Healthcare Clinical Data, Inc /ID# 153425 | Miami | Florida | 33161 | — |
| Ocean Blue Med Research Ctr /ID# 153225 | Miami | Florida | 33166 | — |
| Precision Research Org, LLC /ID# 153276 | Miami Lakes | Florida | 33016-1501 | — |
| Suncoast Clinical Research /ID# 153206 | New Port Richey | Florida | 34652 | — |
| Advanced Research Institute /ID# 153413 | New Port Richey | Florida | 34653 | — |
| Clinical Associates of Orlando /ID# 153427 | Orlando | Florida | 32806 | — |
| Unified Womens Clin Research /ID# 153229 | Panama City | Florida | 32045 | — |
| All Wmns HC of West Broward /ID# 153434 | Plantation | Florida | 33324 | — |
| Oncova Clinical Research, Inc. /ID# 153497 | Saint Cloud | Florida | 34769 | — |
| Physician Care Clin. Res., LLC /ID# 153210 | Sarasota | Florida | 34239 | — |
| Qps-Mra, Llc /Id# 153456 | South Miami | Florida | 33143 | — |
| University of South Florida /ID# 153271 | Tampa | Florida | 33612 | — |
| Axcess Medical Research /ID# 153500 | Wellington | Florida | 33414 | — |
| Virtus Research Consultant,LLC /ID# 153398 | Wellington | Florida | 33414 | — |
| Comprehensive Clinical Trials /ID# 153350 | West Palm Beach | Florida | 33409 | — |
| Atlanta Medical Research Insti /ID# 153298 | Alpharetta | Georgia | 30005-4419 | — |
| Paramount Research Solutions /ID# 153424 | Alpharetta | Georgia | 30005 | — |
| Paramount Research Solutions /ID# 160974 | Alpharetta | Georgia | 30005 | — |
| Mount Vernon Clinical Res, LLC /ID# 153403 | Atlanta | Georgia | 30328 | — |
| Atlanta Women's Research Inst /ID# 153212 | Atlanta | Georgia | 30342 | — |
| Masters of Clinical Research, Inc. /ID# 153295 | Augusta | Georgia | 30909 | — |
| Paramount Research Solutions /ID# 153351 | College Park | Georgia | 30349 | — |
| Fellows Research Alliance, Inc /ID# 153227 | Savannah | Georgia | 31406 | — |
| Clinical Research Consultants of Atlanta /ID# 153285 | Suwanee | Georgia | 30024-6988 | — |
| Atlanta Gynecology Research Institute /ID# 200074 | Suwanee | Georgia | 30024-7159 | — |
| Sonora Clinical Research /ID# 153231 | Meridian | Idaho | 83646-1144 | — |
| Affinity Clinical Research /ID# 153417 | Oak Brook | Illinois | 60523 | — |
| Bluegrass Clinical Research /ID# 153280 | Louisville | Kentucky | 40291 | — |
| Clinical Trials Management, LLC - Covington /ID# 153211 | Covington | Louisiana | 70433 | — |
| Clinical Trials Management, LLC - Covington /ID# 153439 | Covington | Louisiana | 70433 | — |
| Ochsner Baptist Medical Center /ID# 153459 | New Orleans | Louisiana | 70115 | — |
| Omni Fertility and Laser Insti /ID# 153228 | Shreveport | Louisiana | 71118 | — |
| Baltimore Suburban Health /ID# 168386 | Baltimore | Maryland | 21208 | — |
| NECCR Fall River LLC /ID# 153274 | Fall River | Massachusetts | 02720-2972 | — |
| Genesis Clinical Research /ID# 153379 | Fall River | Massachusetts | 02720 | — |
| Great Lakes Research Group,Inc /ID# 153302 | Bay City | Michigan | 48706 | — |
| Saginaw Valley Med Res Group /ID# 153498 | Saginaw | Michigan | 48604 | — |
| Wayne State University Physician Group - Southfield /ID# 153418 | Southfield | Michigan | 48034 | — |
| Accent Clinical Trials /ID# 153474 | Las Vegas | Nevada | 89106-4017 | — |
| Office of Edmond E. Pack, MD /ID# 153411 | Las Vegas | Nevada | 89113 | — |
| Mabey, Las Vegas, NV /ID# 153314 | Las Vegas | Nevada | 89128 | — |
| Lawrence OB/GYN /ID# 153218 | Lawrenceville | New Jersey | 08648 | — |
| Jersey Shore University Medical Center /ID# 153495 | Neptune City | New Jersey | 07753-4859 | — |
| Bosque Women's Care /ID# 153223 | Albuquerque | New Mexico | 87109 | — |
| SUNY Downstate Medical Center /ID# 153344 | Brooklyn | New York | 11203 | — |
| Manhattan Medical Research /ID# 153386 | New York | New York | 10016-6023 | — |
| Weill Cornell Medicine /ID# 153275 | New York | New York | 10032-3725 | — |
| Cwrwc /Id# 153313 | Durham | North Carolina | 27713 | — |
| Unified Women's Clinical Research-Greensboro /ID# 153499 | Greensboro | North Carolina | 27408 | — |
| Pinewest Ob-Gyn, Inc. /ID# 153197 | High Point | North Carolina | 27262 | — |
| Eastern Carolina Women's Centr /ID# 153341 | New Bern | North Carolina | 28562 | — |
| Unified Women's Clinical Resea /ID# 153312 | Raleigh | North Carolina | 27607 | — |
| Wake Research Associates, LLC /ID# 153402 | Raleigh | North Carolina | 27612 | — |
| Unified Women's Clinical Resea /ID# 153297 | Winston-Salem | North Carolina | 27103 | — |
| Clinical Inquest Center Ltd /ID# 153436 | Beavercreek | Ohio | 45432 | — |
| CTI Clinical Research Center /ID# 153201 | Cincinnati | Ohio | 45212 | — |
| University Hospitals Cleveland /ID# 153450 | Cleveland | Ohio | 44106 | — |
| University of Toledo /ID# 153409 | Toledo | Ohio | 43614 | — |
| Comprehensive Womens Care /ID# 153396 | Westerville | Ohio | 43081 | — |
| Legacy Medical Group-Portland /ID# 168286 | Portland | Oregon | 97210 | — |
| Main Line Fertility Center /ID# 153410 | Bryn Mawr | Pennsylvania | 19010 | — |
| Penn State University and Milton S. Hershey Medical Center /ID# 153443 | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania /ID# 153203 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Thomas Jefferson University /ID# 153319 | Philadelphia | Pennsylvania | 19107-4414 | — |
| Clinical Research of Philadelphia, LLC /ID# 153279 | Philadelphia | Pennsylvania | 19114 | — |
| Reading Hosp Clncl Trials Ofc /ID# 153475 | West Reading | Pennsylvania | 19611 | — |
| Medical University of South Carolina /ID# 153325 | Charleston | South Carolina | 29425 | — |
| Vista Clinical Research /ID# 153399 | Columbia | South Carolina | 29201 | — |
| Chattanooga Medical Research /ID# 153405 | Chattanooga | Tennessee | 37404 | — |
| WR-ClinSearch /ID# 153404 | Chattanooga | Tennessee | 37421-1605 | — |
| Research Memphis Associates, LLC /ID# 153322 | Memphis | Tennessee | 38119-3895 | — |
| Women's Health Trials /ID# 153426 | Menphis | Tennessee | 38104 | — |
| Access Clinical Trials, Inc. /ID# 153441 | Nashville | Tennessee | 37203 | — |
| Lotus Gynecology /ID# 153476 | Austin | Texas | 78703-1448 | — |
| Texas Health Presbyterian Hosp /ID# 153339 | Dallas | Texas | 75231 | — |
| UT Southwestern Medical Center /ID# 153400 | Dallas | Texas | 75390-7208 | — |
| Baylor Scott & White /ID# 153273 | Fort Worth | Texas | 76104-4110 | — |
| Willowbend Health and Wellness /ID# 153458 | Frisco | Texas | 75035 | — |
| Advances in Health, Inc. /ID# 153414 | Houston | Texas | 77030 | — |
| The Woman's Hospital of Texas /ID# 153270 | Houston | Texas | 77054 | — |
| FMC Science /ID# 153289 | Lampasas | Texas | 76550 | — |
| Clinical Trials of Texas,Inc. /ID# 153209 | San Antonio | Texas | 78229 | — |
| Discovery Clinical Trials-San Antonio /ID# 153315 | San Antonio | Texas | 78258 | — |
| Houston Ctr for Clin Research /ID# 153221 | Sugar Land | Texas | 77479 | — |
| Center of Reproductive Medicin /ID# 153320 | Webster | Texas | 77598 | — |
| Tidewater Physicians for Women /ID# 153432 | Norfolk | Virginia | 23502 | — |
| Eastern Virginia Med School /ID# 153380 | Norfolk | Virginia | 23507-1627 | — |
| Clinical Research Partners, LL /ID# 153412 | North Chesterfield | Virginia | 23235-4722 | — |
| Clinical Research Partners, LLC /ID# 153343 | Richmond | Virginia | 23220-4459 | — |
| Clinical Trials Virginia, Inc. /ID# 153419 | Richmond | Virginia | 23225 | — |
| Emerson Clinical Research Inst /ID# 153416 | Vienna | Virginia | 22182 | — |
| Virginia Mason Medical Center /ID# 153342 | Seattle | Washington | 98101 | — |
| Seattle Women's Health, Research, Gynecology /ID# 153306 | Seattle | Washington | 98105 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02925494, 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 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 public registry record, listed eligibility criteria, and available contact information for NCT02925494 live on ClinicalTrials.gov.