ClinicalTrials.gov record
Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain
ClinicalTrials.gov ID: NCT04333576
Public ClinicalTrials.gov record NCT04333576. 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 Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico. Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18. There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT04333576
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 800 participants
Conditions and interventions
Conditions
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
- Aug 9, 2020
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
- Last update posted
- Jun 11, 2026
2020 – 2027
United States locations
- U.S. sites
- 176
- U.S. states
- 33
- U.S. cities
- 137
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group /ID# 217062 | Anniston | Alabama | 36207 | — |
| ACCEL Research Sites /ID# 218044 | Birmingham | Alabama | 35218 | — |
| Alabama Clinical Therapeutics /ID# 217166 | Birmingham | Alabama | 35235-3430 | — |
| Alabama Clinical Therapeutics /ID# 222301 | Birmingham | Alabama | 35235-3430 | — |
| University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503 | Birmingham | Alabama | 35294-7333 | — |
| Trinity Research Group /ID# 246932 | Dothan | Alabama | 36301 | — |
| Southern Women's Specialists PC /ID# 217143 | Fairhope | Alabama | 36532-3029 | — |
| Women's Health Alliance of Mobile /ID# 222591 | Mobile | Alabama | 36604-1410 | — |
| Mobile, OBGYN P.C. /ID# 217135 | Mobile | Alabama | 36608 | — |
| North Valley Women's Care /ID# 217092 | Glendale | Arizona | 85308 | — |
| MomDoc Womens Health Research /ID# 221661 | Phoenix | Arizona | 85251 | — |
| Applied Research Center of Arkansas /ID# 248494 | Little Rock | Arkansas | 72212-4187 | — |
| Unity Health- Searcy Medical Center /ID# 217050 | Searcy | Arkansas | 72143-4802 | — |
| Diagnamics Inc. /ID# 225385 | Encinitas | California | 92024 | — |
| Atella Clinical Research /ID# 224024 | La Palma | California | 90623 | — |
| Valley Renal Medical Group Research /ID# 228614 | Northridge | California | 91324-4622 | — |
| Futura Research, Org /ID# 217361 | Norwalk | California | 90650 | — |
| Northern California Research /ID# 217301 | Sacramento | California | 95821-2640 | — |
| A & B Clinical Research /ID# 224471 | San Diego | California | 92103-3363 | — |
| Advanced Clinical Research Center, LLC /ID# 248398 | San Diego | California | 92119-3434 | — |
| Rocky Mountain Internal Medicine - Aurora /ID# 245161 | Aurora | Colorado | 80012-4505 | — |
| Velocity Clinical Research - Denver /ID# 217297 | Denver | Colorado | 80209-3804 | — |
| Boeson Research - Grand Junction /ID# 248580 | Grand Junction | Colorado | 81505-1018 | — |
| Advanced Women's Health Institute /ID# 217150 | Greenwood Village | Colorado | 80111 | — |
| Red Rocks OB/GYN /ID# 217103 | Lakewood | Colorado | 80228-1810 | — |
| Reproductive Assoc of Delaware /ID# 227764 | Newark | Delaware | 19713 | — |
| Medstar Health Research Institute /ID# 244937 | Washington D.C. | District of Columbia | 20010 | — |
| James A. Simon, MD, PC /ID# 218116 | Washington D.C. | District of Columbia | 20036 | — |
| Topaz Clinical Research /ID# 218615 | Apopka | Florida | 32703-5835 | — |
| Ideal Clinical Research Inc. /ID# 218832 | Aventura | Florida | 33180 | — |
| Helix Biomedics, LLC /ID# 218649 | Boynton Beach | Florida | 33436-6634 | — |
| Olympian Clinical Research /ID# 244426 | Clearwater | Florida | 33756 | — |
| Women's Medical Research Group /ID# 218524 | Clearwater | Florida | 33759 | — |
| Doral Medical Research, LLC /ID# 225146 | Doral | Florida | 33166-6658 | — |
| Universal Axon Clinical Research /ID# 248553 | Doral | Florida | 33166 | — |
| KO Clinical Research, LLC /ID# 217173 | Fort Lauderdale | Florida | 33316 | — |
| Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061 | Fort Myers | Florida | 33912 | — |
| Solutions Through Adv Rch /ID# 220973 | Jacksonville | Florida | 32256 | — |
| Care Partners Clinical Research /ID# 217042 | Jacksonville | Florida | 32277 | — |
| Vida Clinical Research /ID# 245325 | Kissimmee | Florida | 34741-2358 | — |
| Kissimmee Clinical Research /ID# 224749 | Kissimmee | Florida | 34741 | — |
| South Florida Wellness & Clinic /ID# 222897 | Margate | Florida | 33063 | — |
| GRE Clinical Research, LLC /ID# 246579 | Miami | Florida | 33145-2457 | — |
| Gold Coast Health Research, LLC /ID# 248624 | Miami | Florida | 33155-1402 | — |
| Admed Research LLC /ID# 227679 | Miami | Florida | 33173 | — |
| The Miami Research Group Inc /ID# 246578 | Miami | Florida | 33174 | — |
| Innova Pharma Research /ID# 245354 | Miami | Florida | 33175-8802 | — |
| Ocean Blue Medical Research Center, Inc /ID# 217286 | Miami Springs | Florida | 33166 | — |
| Salom Tangir, LLC /ID# 217273 | Miramar | Florida | 33027 | — |
| Suncoast Clinical Research Pasco County /ID# 217249 | New Port Richey | Florida | 34652 | — |
| Advanced Research Institute, Inc /ID# 217206 | New Port Richey | Florida | 34653 | — |
| Segal Institute for Clinical Research /ID# 221518 | North Miami | Florida | 33161-5821 | — |
| A Premier Medical Research of FL /ID# 216908 | Orange City | Florida | 32763-2833 | — |
| Osceola Gynecology, LLC - Orlando /ID# 227194 | Orlando | Florida | 32806-5412 | — |
| Omega Research Group /ID# 216907 | Orlando | Florida | 32808 | — |
| Clinical Associates of Orlando /ID# 218114 | Orlando | Florida | 32819-8900 | — |
| Duplicate_Suncoast Clinical Research - Palm Harbor /ID# 219133 | Palm Harbor | Florida | 34684 | — |
| Royal Research,Corp /ID# 221356 | Pembroke Pines | Florida | 33027-1003 | — |
| Physician Care Clin. Res., LLC /ID# 217264 | Sarasota | Florida | 34239 | — |
| Tampa General Hospital - Tampa - General Circle /ID# 217146 | Tampa | Florida | 33606 | — |
| GCP Clinical Research, LLC /ID# 217232 | Tampa | Florida | 33609-4044 | — |
| Virtus Research Consultants, LLC /ID# 217052 | Wellington | Florida | 33414 | — |
| Florida Premier Research Institute, LLC /ID# 224499 | Winter Park | Florida | 32789-4681 | — |
| Paramount Research Solutions /ID# 218769 | Alpharetta | Georgia | 30005 | — |
| Academia of Women's Health & Endoscopic Surgery /ID# 217260 | Atlanta | Georgia | 30328 | — |
| Gyn & Fertility Specialists /ID# 223015 | Atlanta | Georgia | 30342-1731 | — |
| Atlanta Women's Research Institute /ID# 217303 | Atlanta | Georgia | 30342 | — |
| Paramount Research Solutions - College Park /ID# 217358 | College Park | Georgia | 30349-3103 | — |
| Duplicate_Columbus Regional Research Ins /ID# 217294 | Columbus | Georgia | 31904 | — |
| Midtown OBGYN North /ID# 222300 | Columbus | Georgia | 31909-5715 | — |
| Innovative Women's HealthCare Solutions - Smyrna /ID# 223692 | Smyrna | Georgia | 30082-5166 | — |
| Journey Medical Research Institute - Snellville /ID# 229774 | Snellville | Georgia | 30078-6191 | — |
| Leavitt Womens Healthcare /ID# 217118 | Idaho Falls | Idaho | 83404 | — |
| Womens Healthcare Assoc, DBA /ID# 222153 | Idaho Falls | Idaho | 83404 | — |
| Sonora Clinical Research /ID# 222147 | Meridian | Idaho | 83646-1144 | — |
| Asr, Llc /Id# 217094 | Nampa | Idaho | 83687 | — |
| Women's Health Care Center Of Chicago /ID# 245164 | Chicago | Illinois | 60639-2103 | — |
| Alliance for Multispecialty Research, LLC /ID# 217226 | Oak Brook | Illinois | 60523 | — |
| The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372 | Park Ridge | Illinois | 60068 | — |
| American Health Network of IN, LLC (Avon) /ID# 218023 | Avon | Indiana | 46123-7960 | — |
| Investigators Research Group, LLC /ID# 222891 | Brownsburg | Indiana | 46112 | — |
| Women's Health Advantage /ID# 246580 | Fort Wayne | Indiana | 46825 | — |
| University of Iowa Hospitals and Clinics /ID# 217144 | Iowa City | Iowa | 52242 | — |
| The Iowa Clinic, PC /ID# 217351 | West Des Moines | Iowa | 50266-8216 | — |
| GTC Research /ID# 217051 | Shawnee Mission | Kansas | 66218 | — |
| Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040 | Wichita | Kansas | 67205-1138 | — |
| Cypress Medical Research Ctr /ID# 217093 | Wichita | Kansas | 67226 | — |
| Clinical Trials Management - Metairie /ID# 217054 | Covington | Louisiana | 70433-4966 | — |
| Clinical Trials Management, LLC - Covington /ID# 217291 | Covington | Louisiana | 70433 | — |
| Horizon Research Group /ID# 217100 | Eunice | Louisiana | 70535 | — |
| Praetorian Pharmaceutical Research /ID# 217159 | Marrero | Louisiana | 70072 | — |
| Southern Clinical Research A /ID# 218028 | Metairie | Louisiana | 70001 | — |
| Women's Health Clinic /ID# 217205 | Shreveport | Louisiana | 71118-3133 | — |
| SBL Special Services LLC /ID# 224899 | Frederick | Maryland | 21702-4301 | — |
| Congressional OBGYN /ID# 245349 | Rockville | Maryland | 20850-8726 | — |
| Continental Clinical Solutions /ID# 217053 | Towson | Maryland | 21204 | — |
| NECCR Fall River LLC /ID# 217108 | Fall River | Massachusetts | 02720-2972 | — |
| Exordia Medical Research, Inc /ID# 217116 | Fall River | Massachusetts | 02723 | — |
| Great Lakes Research Group - Bay City /ID# 217099 | Bay City | Michigan | 48706 | — |
| Wayne State University, C.S. Mott Center /ID# 248422 | Detroit | Michigan | 48201-1406 | — |
| Saginaw Valley Med Res Group /ID# 217296 | Saginaw | Michigan | 48604 | — |
| Center for Reproductive Medicine and Robotic Surgery /ID# 223494 | St Louis | Missouri | 63141 | — |
| Boeson Research - Great Falls /ID# 248560 | Great Falls | Montana | 59405-5315 | — |
| Boeson Research - Missoula /ID# 248559 | Missoula | Montana | 59804-7419 | — |
| Womens Clinic of Lincoln, P.C. /ID# 217136 | Lincoln | Nebraska | 68510 | — |
| Private practice: Dr. Rex G. Mabey JR /ID# 217134 | Las Vegas | Nevada | 89128 | — |
| Dr. Nader and Associates M.D. P.C. /ID# 223571 | North Las Vegas | Nevada | 89030-7187 | — |
| Cooper University Hospital /ID# 227208 | Camden | New Jersey | 08103 | — |
| Jersey Shore University Medical Center /ID# 217138 | Neptune City | New Jersey | 07753-4859 | — |
| Rutgers Robert Wood Johnson /ID# 246933 | New Brunswick | New Jersey | 08901 | — |
| Maimonides Medical Center /ID# 248493 | Brooklyn | New York | 11219 | — |
| Invision Health /ID# 218687 | Buffalo | New York | 14221-5771 | — |
| Widewaters Gynecology /ID# 225621 | East Syracuse | New York | 13057-3072 | — |
| Parkmed NYC /ID# 224333 | New York | New York | 10017-4709 | — |
| Columbia Univ Medical Center /ID# 217113 | New York | New York | 10032-3725 | — |
| New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329 | New York | New York | 10065 | — |
| Richmond OB/GYN Associates PC /ID# 224833 | Staten Island | New York | 10306 | — |
| Duplicate_PMG Research of Charlotte /ID# 217224 | Charlotte | North Carolina | 28209 | — |
| Tyron Medical Partners, PLLC /ID# 245286 | Charlotte | North Carolina | 28211-5055 | — |
| Carolina Women's Research and Wellness Center /ID# 217133 | Durham | North Carolina | 27713 | — |
| Eastern Carolina Women's Centr /ID# 222358 | New Bern | North Carolina | 28562 | — |
| Accellacare Wilmington /ID# 217097 | Wilmington | North Carolina | 28401 | — |
| Carolina Medical Trials - Winston-Salem /ID# 223002 | Winston-Salem | North Carolina | 27103-4109 | — |
| Unified Women's Clinical Research /ID# 217132 | Winston-Salem | North Carolina | 27103 | — |
| Unified Women's Clinical Research /ID# 218339 | Winston-Salem | North Carolina | 27103 | — |
| Clinical Inquest Center Ltd /ID# 217961 | Beavercreek | Ohio | 45431-2573 | — |
| Neuro-Behavioral Clinical Research, Inc. /ID# 224026 | Canton | Ohio | 44720 | — |
| Seven Hills Clinical Research Group /ID# 224941 | Cincinnati | Ohio | 45255 | — |
| Duplicate_Duplicate_University Of Cincinnati Medical Center /ID# 217349 | Cincinnati | Ohio | 45267-0585 | — |
| MetroHealth Medical Center /ID# 224392 | Cleveland | Ohio | 44109 | — |
| Central Ohio Clinical Research /ID# 217059 | Columbus | Ohio | 43213-3399 | — |
| HWC Women's Research Center /ID# 246619 | Englewood | Ohio | 45322 | — |
| Wright State Physicians Health Center /ID# 217272 | Fairborn | Ohio | 45324 | — |
| Marion Ob/Gyn Inc. /ID# 244175 | Marion | Ohio | 43302-6318 | — |
| Univ Hosp Landerbrook /ID# 217065 | Mayfield Heights | Ohio | 44124 | — |
| AC Clinical Research /ID# 227356 | Tiffin | Ohio | 44883 | — |
| Grube Gynecology /ID# 245132 | Frackville | Pennsylvania | 17931-2105 | — |
| Penn State University and Milton S. Hershey Medical Center /ID# 217057 | Hershey | Pennsylvania | 17033-2360 | — |
| University of Pennsylvania /ID# 217243 | Philadelphia | Pennsylvania | 19104-5502 | — |
| reading Hospital /ID# 223599 | Wyomissing | Pennsylvania | 19611 | — |
| Vista Clinical Research /ID# 217151 | Columbia | South Carolina | 29201 | — |
| University Medical Group /ID# 217355 | Greenville | South Carolina | 29605 | — |
| Vitalink Research - Greenville /ID# 217075 | Greenville | South Carolina | 29615 | — |
| Duplicate_Palmetto Clinical Research /ID# 217069 | Summerville | South Carolina | 29485-7539 | — |
| Biocentric Healthcare Research /ID# 248582 | West Columbia | South Carolina | 29169-3612 | — |
| Chattanooga Research and Medicine /ID# 217045 | Chattanooga | Tennessee | 37412-3964 | — |
| Research Memphis Associates, LLC /ID# 218022 | Memphis | Tennessee | 38119-3895 | — |
| Access Clinical Trials, Inc. /ID# 217055 | Nashville | Tennessee | 37203 | — |
| DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095 | Dallas | Texas | 75230 | — |
| Cedar Health Research /ID# 224407 | Dallas | Texas | 75251-2202 | — |
| Duplicate_The University of Texas Southwestern Medical Center /ID# 217048 | Dallas | Texas | 75390-8575 | — |
| Signature Gyn Services /ID# 217299 | Fort Worth | Texas | 76104 | — |
| Progressive Women's Health /ID# 248402 | Friendswood | Texas | 77546-3988 | — |
| Willowbend Health and Wellness - Frisco /ID# 217354 | Frisco | Texas | 75035 | — |
| FMC Science, LLC - OB/GYN - Georgetown /ID# 218654 | Georgetown | Texas | 78626-8185 | — |
| UTHealth Women's Research Program - Memorial City /ID# 217362 | Houston | Texas | 77024 | — |
| OBGYN Medical Center Associates - Medical Center Office /ID# 245346 | Houston | Texas | 77054-2934 | — |
| Centex Studies, Inc. - Houston /ID# 217357 | Houston | Texas | 77058 | — |
| FMC Science /ID# 217047 | Lampasas | Texas | 76550 | — |
| Maximos OB/GYN /ID# 229385 | League City | Texas | 77573-2681 | — |
| Advances in Health, Inc. /ID# 217220 | Pearland | Texas | 77854 | — |
| Clinical Trials of Texas, Inc /ID# 217039 | San Antonio | Texas | 78229 | — |
| VIP Trials /ID# 217261 | San Antonio | Texas | 78230 | — |
| Discovery Clinical Trials-San Antonio /ID# 218547 | San Antonio | Texas | 78258 | — |
| Center of Reproductive Medicine /ID# 217241 | Webster | Texas | 77598 | — |
| Corner Canyon Obstetrics and G /ID# 217289 | Draper | Utah | 84020 | — |
| Duplicate_Physicians Research Options /ID# 217302 | Pleasant Grove | Utah | 84062 | — |
| Highland Clinical Research /ID# 224052 | Salt Lake City | Utah | 84124 | — |
| Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063 | Newport News | Virginia | 23606 | — |
| Clinical Research Partners /ID# 217359 | North Chesterfield | Virginia | 23235 | — |
| Virginia Women's Health Associates /ID# 227677 | Reston | Virginia | 20190-3215 | — |
| Clinical Trials Virginia, Inc. /ID# 217222 | Richmond | Virginia | 23225 | — |
| Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149 | Richmond | Virginia | 23226-3786 | — |
| Tidewater Clinical Research /ID# 217152 | Virginia Beach | Virginia | 23456 | — |
| Seattle Clinical Research Center /ID# 217117 | Seattle | Washington | 98105 | — |
| North Spokane Women's Health /ID# 217356 | Spokane | Washington | 99207 | — |
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 NCT04333576, 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 11, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04333576 live on ClinicalTrials.gov.