Endometriosis Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 800 |
| Est. completion date | June 1, 2030 |
| Est. primary completion date | December 5, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 49 Years |
| Eligibility | Inclusion Criteria: - Documented surgical confirmation of endometriosis and associated moderate to severe pain. - Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study. - Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs). Exclusion Criteria: - Pregnant or breastfeeding or planning a pregnancy until completion of the study. - Surgical history of hysterectomy or bilateral oophorectomy. - Participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from Screening. - Participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Advanced Medical Concepts. PSC /ID# 221337 | Cidra | |
| Puerto Rico | Henry A. Rodriguez Ginorio, MD /ID# 217233 | San Juan | |
| Puerto Rico | School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235 | San Juan | |
| United States | Paramount Research Solutions /ID# 218769 | Alpharetta | Georgia |
| United States | Pinnacle Research Group /ID# 217062 | Anniston | Alabama |
| United States | Topaz Clinical Research /ID# 218615 | Apopka | Florida |
| United States | Academia of Women's Health & Endoscopic Surgery /ID# 217260 | Atlanta | Georgia |
| United States | Atlanta Women's Research Institute /ID# 217303 | Atlanta | Georgia |
| United States | Gyn & Fertility Specialists /ID# 223015 | Atlanta | Georgia |
| United States | Rocky Mountain Internal Medicine - Aurora /ID# 245161 | Aurora | Colorado |
| United States | Ideal Clinical Research Inc. /ID# 218832 | Aventura | Florida |
| United States | American Health Network of IN, LLC (Avon) /ID# 218023 | Avon | Indiana |
| United States | Great Lakes Research Group - Bay City /ID# 217099 | Bay City | Michigan |
| United States | Clinical Inquest Center Ltd /ID# 217961 | Beavercreek | Ohio |
| United States | ACCEL Research Sites /ID# 218044 | Birmingham | Alabama |
| United States | Alabama Clinical Therapeutics /ID# 217166 | Birmingham | Alabama |
| United States | Alabama Clinical Therapeutics /ID# 222301 | Birmingham | Alabama |
| United States | University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503 | Birmingham | Alabama |
| United States | Helix Biomedics, LLC /ID# 218649 | Boynton Beach | Florida |
| United States | Maimonides Medical Center /ID# 248493 | Brooklyn | New York |
| United States | Investigators Research Group, LLC /ID# 222891 | Brownsburg | Indiana |
| United States | Invision Health /ID# 218687 | Buffalo | New York |
| United States | Cooper University Hospital /ID# 227208 | Camden | New Jersey |
| United States | Neuro-Behavioral Clinical Research, Inc. /ID# 224026 | Canton | Ohio |
| United States | PMG Research of Charlotte /ID# 217224 | Charlotte | North Carolina |
| United States | Tyron Medical Partners, PLLC /ID# 245286 | Charlotte | North Carolina |
| United States | Chattanooga Research and Medicine /ID# 217045 | Chattanooga | Tennessee |
| United States | Women's Health Care Center Of Chicago /ID# 245164 | Chicago | Illinois |
| United States | Seven Hills Clinical Research Group /ID# 224941 | Cincinnati | Ohio |
| United States | University of Cincinnati /ID# 217349 | Cincinnati | Ohio |
| United States | Olympian Clinical Research /ID# 244426 | Clearwater | Florida |
| United States | Women's Medical Research Group /ID# 218524 | Clearwater | Florida |
| United States | MetroHealth Medical Center /ID# 224392 | Cleveland | Ohio |
| United States | Paramount Research Solutions - College Park /ID# 217358 | College Park | Georgia |
| United States | Vista Clinical Research /ID# 217151 | Columbia | South Carolina |
| United States | Central Ohio Clinical Research /ID# 217059 | Columbus | Ohio |
| United States | Columbus Regional Research Ins /ID# 217294 | Columbus | Georgia |
| United States | Midtown OBGYN North /ID# 222300 | Columbus | Georgia |
| United States | Clinical Trials Management - Metairie /ID# 217054 | Covington | Louisiana |
| United States | Clinical Trials Management, LLC - Covington /ID# 217291 | Covington | Louisiana |
| United States | Cedar Health Research /ID# 224407 | Dallas | Texas |
| United States | DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095 | Dallas | Texas |
| United States | Duplicate_The University of Texas Southwestern Medical Center /ID# 217048 | Dallas | Texas |
| United States | Velocity Clinical Research - Denver /ID# 217297 | Denver | Colorado |
| United States | Wayne State University, C.S. Mott Center /ID# 248422 | Detroit | Michigan |
| United States | Doral Medical Research, LLC /ID# 225146 | Doral | Florida |
| United States | Universal Axon Clinical Research /ID# 248553 | Doral | Florida |
| United States | Trinity Research Group /ID# 246932 | Dothan | Alabama |
| United States | Corner Canyon Obstetrics and G /ID# 217289 | Draper | Utah |
| United States | Carolina Women's Research and Wellness Center /ID# 217133 | Durham | North Carolina |
| United States | Widewaters Gynecology /ID# 225621 | East Syracuse | New York |
| United States | Diagnamics Inc. /ID# 225385 | Encinitas | California |
| United States | HWC Women's Research Center /ID# 246619 | Englewood | Ohio |
| United States | Horizon Research Group /ID# 217100 | Eunice | Louisiana |
| United States | Wright State Physicians - Fairborn /ID# 217272 | Fairborn | Ohio |
| United States | Southern Women's Specialists PC /ID# 217143 | Fairhope | Alabama |
| United States | Exordia Medical Research, Inc /ID# 217116 | Fall River | Massachusetts |
| United States | NECCR Fall River LLC /ID# 217108 | Fall River | Massachusetts |
| United States | KO Clinical Research, LLC /ID# 217173 | Fort Lauderdale | Florida |
| United States | Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061 | Fort Myers | Florida |
| United States | Women's Health Advantage /ID# 246580 | Fort Wayne | Indiana |
| United States | Signature Gyn Services /ID# 217299 | Fort Worth | Texas |
| United States | Grube Gynecology /ID# 245132 | Frackville | Pennsylvania |
| United States | SBL Special Services LLC /ID# 224899 | Frederick | Maryland |
| United States | Progressive Women's Health /ID# 248402 | Friendswood | Texas |
| United States | Willowbend Health and Wellness - Frisco /ID# 217354 | Frisco | Texas |
| United States | FMC Science, LLC - OB/GYN - Georgetown /ID# 218654 | Georgetown | Texas |
| United States | Boeson Research - Grand Junction /ID# 248580 | Grand Junction | Colorado |
| United States | Boeson Research - Great Falls /ID# 248560 | Great Falls | Montana |
| United States | University Medical Group /ID# 217355 | Greenville | South Carolina |
| United States | Vitalink Research - Greenville /ID# 217075 | Greenville | South Carolina |
| United States | Advanced Women's Health Institute /ID# 217150 | Greenwood Village | Colorado |
| United States | Penn State University and Milton S. Hershey Medical Center /ID# 217057 | Hershey | Pennsylvania |
| United States | Centex Studies, Inc. - Houston /ID# 217357 | Houston | Texas |
| United States | OBGYN Medical Center Associates - Medical Center Office /ID# 245346 | Houston | Texas |
| United States | UTHealth Women's Research Program - Memorial City /ID# 217362 | Houston | Texas |
| United States | Leavitt Womens Healthcare /ID# 217118 | Idaho Falls | Idaho |
| United States | Womens Healthcare Assoc, DBA /ID# 222153 | Idaho Falls | Idaho |
| United States | University of Iowa Hospitals and Clinics /ID# 217144 | Iowa City | Iowa |
| United States | Care Partners Clinical Research /ID# 217042 | Jacksonville | Florida |
| United States | Solutions Through Adv Rch /ID# 220973 | Jacksonville | Florida |
| United States | Kissimmee Clinical Research /ID# 224749 | Kissimmee | Florida |
| United States | Vida Clinical Research /ID# 245325 | Kissimmee | Florida |
| United States | Atella Clinical Research /ID# 224024 | La Palma | California |
| United States | Red Rocks OB/GYN /ID# 217103 | Lakewood | Colorado |
| United States | FMC Science /ID# 217047 | Lampasas | Texas |
| United States | Private practice: Dr. Rex G. Mabey JR /ID# 217134 | Las Vegas | Nevada |
| United States | Maximos OB/GYN /ID# 229385 | League City | Texas |
| United States | Womens Clinic of Lincoln, P.C. /ID# 217136 | Lincoln | Nebraska |
| United States | Applied Research Center of Arkansas /ID# 248494 | Little Rock | Arkansas |
| United States | South Florida Wellness & Clinic /ID# 222897 | Margate | Florida |
| United States | Marion Ob/Gyn Inc. /ID# 244175 | Marion | Ohio |
| United States | Praetorian Pharmaceutical Research /ID# 217159 | Marrero | Louisiana |
| United States | Univ Hosp Landerbrook /ID# 217065 | Mayfield Heights | Ohio |
| United States | Research Memphis Associates, LLC /ID# 218022 | Memphis | Tennessee |
| United States | Sonora Clinical Research /ID# 222147 | Meridian | Idaho |
| United States | Mesa Obstetricians and Gynecologists /ID# 217092 | Mesa | Arizona |
| United States | Southern Clinical Research A /ID# 218028 | Metairie | Louisiana |
| United States | Admed Research LLC /ID# 227679 | Miami | Florida |
| United States | Gold Coast Health Research, LLC /ID# 248624 | Miami | Florida |
| United States | GRE Clinical Research, LLC /ID# 246579 | Miami | Florida |
| United States | Innova Pharma Research /ID# 245354 | Miami | Florida |
| United States | The Miami Research Group Inc /ID# 246578 | Miami | Florida |
| United States | Ocean Blue Medical Research Center, Inc /ID# 217286 | Miami Springs | Florida |
| United States | Salom Tangir, LLC /ID# 217273 | Miramar | Florida |
| United States | Boeson Research - Missoula /ID# 248559 | Missoula | Montana |
| United States | Mobile, OBGYN P.C. /ID# 217135 | Mobile | Alabama |
| United States | Women's Health Alliance of Mobile /ID# 222591 | Mobile | Alabama |
| United States | Asr, Llc /Id# 217094 | Nampa | Idaho |
| United States | Access Clinical Trials, Inc. /ID# 217055 | Nashville | Tennessee |
| United States | Jersey Shore University Medical Center /ID# 217138 | Neptune | New Jersey |
| United States | Eastern Carolina Women's Centr /ID# 222358 | New Bern | North Carolina |
| United States | Rutgers Robert Wood Johnson /ID# 246933 | New Brunswick | New Jersey |
| United States | Advanced Research Institute, Inc /ID# 217206 | New Port Richey | Florida |
| United States | Suncoast Clinical Research Pasco County /ID# 217249 | New Port Richey | Florida |
| United States | Columbia Univ Medical Center /ID# 217113 | New York | New York |
| United States | New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329 | New York | New York |
| United States | Parkmed NYC /ID# 224333 | New York | New York |
| United States | Reproductive Assoc of Delaware /ID# 227764 | Newark | Delaware |
| United States | Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063 | Newport News | Virginia |
| United States | Clinical Research Partners /ID# 217359 | North Chesterfield | Virginia |
| United States | Dr. Nader and Associates M.D. P.C. /ID# 223571 | North Las Vegas | Nevada |
| United States | Segal Institute for Clinical Research /ID# 221518 | North Miami | Florida |
| United States | Valley Renal Medical Group Research /ID# 228614 | Northridge | California |
| United States | Futura Research, Org /ID# 217361 | Norwalk | California |
| United States | Alliance for Multispecialty Research, LLC /ID# 217226 | Oak Brook | Illinois |
| United States | A Premier Medical Research of FL /ID# 216908 | Orange City | Florida |
| United States | Clinical Associates of Orlando /ID# 218114 | Orlando | Florida |
| United States | Omega Research Group /ID# 216907 | Orlando | Florida |
| United States | Osceola Gynecology, LLC - Orlando /ID# 227194 | Orlando | Florida |
| United States | Suncoast Clinical Research - Palm Harbor /ID# 219133 | Palm Harbor | Florida |
| United States | The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372 | Park Ridge | Illinois |
| United States | Advances in Health, Inc. /ID# 217220 | Pearland | Texas |
| United States | Royal Research,Corp /ID# 221356 | Pembroke Pines | Florida |
| United States | University of Pennsylvania /ID# 217243 | Philadelphia | Pennsylvania |
| United States | MomDoc Womens Health Research /ID# 221661 | Phoenix | Arizona |
| United States | Physicians Research Options /ID# 217302 | Pleasant Grove | Utah |
| United States | Virginia Women's Health Associates /ID# 227677 | Reston | Virginia |
| United States | Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149 | Richmond | Virginia |
| United States | Clinical Trials Virginia, Inc. /ID# 217222 | Richmond | Virginia |
| United States | Congressional OBGYN /ID# 245349 | Rockville | Maryland |
| United States | Northern California Research /ID# 217301 | Sacramento | California |
| United States | Saginaw Valley Med Res Group /ID# 217296 | Saginaw | Michigan |
| United States | Center for Reproductive Medicine and Robotic Surgery /ID# 223494 | Saint Louis | Missouri |
| United States | Highland Clinical Research /ID# 224052 | Salt Lake City | Utah |
| United States | Clinical Trials of Texas, Inc /ID# 217039 | San Antonio | Texas |
| United States | Discovery Clinical Trials-San Antonio /ID# 218547 | San Antonio | Texas |
| United States | VIP Trials /ID# 217261 | San Antonio | Texas |
| United States | A & B Clinical Research /ID# 224471 | San Diego | California |
| United States | Advanced Clinical Research Center, LLC /ID# 248398 | San Diego | California |
| United States | Physician Care Clin. Res., LLC /ID# 217264 | Sarasota | Florida |
| United States | Unity Health- Searcy Medical Center /ID# 217050 | Searcy | Arkansas |
| United States | Seattle Clinical Research Center /ID# 217117 | Seattle | Washington |
| United States | GTC Research /ID# 217051 | Shawnee Mission | Kansas |
| United States | Women's Health Clinic /ID# 217205 | Shreveport | Louisiana |
| United States | Innovative Women's HealthCare Solutions - Smyrna /ID# 223692 | Smyrna | Georgia |
| United States | Journey Medical Research Institute - Snellville /ID# 229774 | Snellville | Georgia |
| United States | North Spokane Women's Health /ID# 217356 | Spokane | Washington |
| United States | Richmond OB/GYN Associates PC /ID# 224833 | Staten Island | New York |
| United States | Duplicate_Palmetto Clinical Research /ID# 217069 | Summerville | South Carolina |
| United States | GCP Clinical Research, LLC /ID# 217232 | Tampa | Florida |
| United States | University of South Florida- Neuroscience Institute /ID# 217146 | Tampa | Florida |
| United States | AC Clinical Research /ID# 227356 | Tiffin | Ohio |
| United States | Continental Clinical Solutions /ID# 217053 | Towson | Maryland |
| United States | Tidewater Clinical Research /ID# 217152 | Virginia Beach | Virginia |
| United States | James A. Simon, MD, PC /ID# 218116 | Washington | District of Columbia |
| United States | Medstar Health Research Institute /ID# 244937 | Washington | District of Columbia |
| United States | Center of Reproductive Medicine /ID# 217241 | Webster | Texas |
| United States | Virtus Research Consultants, LLC /ID# 217052 | Wellington | Florida |
| United States | Biocentric Healthcare Research /ID# 248582 | West Columbia | South Carolina |
| United States | The Iowa Clinic, PC /ID# 217351 | West Des Moines | Iowa |
| United States | Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040 | Wichita | Kansas |
| United States | Cypress Medical Research Ctr /ID# 217093 | Wichita | Kansas |
| United States | PMG Research of Wilmington LLC /ID# 217097 | Wilmington | North Carolina |
| United States | Carolina Medical Trials - Winston-Salem /ID# 223002 | Winston-Salem | North Carolina |
| United States | Unified Women's Clinical Resea /ID# 217132 | Winston-Salem | North Carolina |
| United States | Unified Women's Clinical Resea /ID# 218339 | Winston-Salem | North Carolina |
| United States | Florida Premier Research Institute, LLC /ID# 224499 | Winter Park | Florida |
| United States | reading Hospital /ID# 223599 | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale | DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use. | Month 3 | |
| Secondary | Percentage of Responders Based on Non-Menstrual Pelvic Pain (NMPP) Pain Scale | NMPP response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use. | Month 3 |
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