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
Endometriosis
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Elagolix, Combined oral contraceptives (COC), Orilissa, Dysmenorrhea
Eligibility Criteria
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.
Sites / Locations
- Pinnacle Research Group /ID# 217062
- ACCEL Research Sites /ID# 218044Recruiting
- Alabama Clinical Therapeutics /ID# 217166Recruiting
- Alabama Clinical Therapeutics /ID# 222301Recruiting
- University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503Recruiting
- Trinity Research Group /ID# 246932Recruiting
- Southern Women's Specialists PC /ID# 217143
- Women's Health Alliance of Mobile /ID# 222591Recruiting
- Mobile, OBGYN P.C. /ID# 217135
- Mesa Obstetricians and Gynecologists /ID# 217092Recruiting
- MomDoc Womens Health Research /ID# 221661
- Applied Research Center of Arkansas /ID# 248494Recruiting
- Unity Health- Searcy Medical Center /ID# 217050Recruiting
- Diagnamics Inc. /ID# 225385Recruiting
- Atella Clinical Research /ID# 224024
- Valley Renal Medical Group Research /ID# 228614
- Futura Research, Org /ID# 217361
- Northern California Research /ID# 217301Recruiting
- A & B Clinical Research /ID# 224471Recruiting
- Advanced Clinical Research Center, LLC /ID# 248398
- Rocky Mountain Internal Medicine - Aurora /ID# 245161
- Velocity Clinical Research - Denver /ID# 217297
- Boeson Research - Grand Junction /ID# 248580
- Advanced Women's Health Institute /ID# 217150Recruiting
- Red Rocks OB/GYN /ID# 217103Recruiting
- Reproductive Assoc of Delaware /ID# 227764
- Medstar Health Research Institute /ID# 244937
- James A. Simon, MD, PC /ID# 218116Recruiting
- Topaz Clinical Research /ID# 218615Recruiting
- Ideal Clinical Research Inc. /ID# 218832Recruiting
- Helix Biomedics, LLC /ID# 218649Recruiting
- Olympian Clinical Research /ID# 244426Recruiting
- Women's Medical Research Group /ID# 218524
- Doral Medical Research, LLC /ID# 225146Recruiting
- Universal Axon Clinical Research /ID# 248553Recruiting
- KO Clinical Research, LLC /ID# 217173
- Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061
- Solutions Through Adv Rch /ID# 220973Recruiting
- Care Partners Clinical Research /ID# 217042
- Vida Clinical Research /ID# 245325Recruiting
- Kissimmee Clinical Research /ID# 224749Recruiting
- South Florida Wellness & Clinic /ID# 222897Recruiting
- Ocean Blue Medical Research Center, Inc /ID# 217286
- GRE Clinical Research, LLC /ID# 246579Recruiting
- Gold Coast Health Research, LLC /ID# 248624Recruiting
- Admed Research LLC /ID# 227679
- The Miami Research Group Inc /ID# 246578Recruiting
- Innova Pharma Research /ID# 245354Recruiting
- Salom Tangir, LLC /ID# 217273
- Suncoast Clinical Research /ID# 217249Recruiting
- Advanced Research Institute, Inc /ID# 217206Recruiting
- Segal Institute for Clinical Research /ID# 221518
- A Premier Medical Research of FL /ID# 216908
- Osceola Gynecology, LLC - Orlando /ID# 227194Recruiting
- Omega Research Group /ID# 216907Recruiting
- Clinical Associates of Orlando /ID# 218114Recruiting
- Suncoast Clinical Research - Palm Harbor /ID# 219133
- Royal Research,Corp /ID# 221356Recruiting
- Physician Care Clin. Res., LLC /ID# 217264Recruiting
- GCP Clinical Research, LLC /ID# 217232Recruiting
- University of South Florida /ID# 217146Recruiting
- Virtus Research Consultants, LLC /ID# 217052
- Florida Premier Research Institute, LLC /ID# 224499
- Paramount Research Solutions /ID# 218769
- Academia of Women's Health & Endoscopic Surgery /ID# 217260Recruiting
- Gyn & Fertility Specialists /ID# 223015
- Atlanta Women's Research Institute /ID# 217303
- Paramount Research Solutions - College Park /ID# 217358Recruiting
- Columbus Regional Research Ins /ID# 217294Recruiting
- Midtown OBGYN North /ID# 222300Recruiting
- Innovative Women's HealthCare Solutions - Smyrna /ID# 223692Recruiting
- Journey Medical Research Institute - Snellville /ID# 229774Recruiting
- Leavitt Womens Healthcare /ID# 217118Recruiting
- Womens Healthcare Assoc, DBA /ID# 222153Recruiting
- Sonora Clinical Research /ID# 222147Recruiting
- Asr, Llc /Id# 217094
- Women's Health Care Center Of Chicago /ID# 245164
- Affinity Health /ID# 217226
- The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 245372Recruiting
- American Health Network of IN, LLC (Avon) /ID# 218023
- Investigators Research Group, LLC /ID# 222891Recruiting
- Women's Health Advantage /ID# 246580Recruiting
- University of Iowa Hospitals and Clinics /ID# 217144Recruiting
- The Iowa Clinic, PC /ID# 217351Recruiting
- GTC Research /ID# 217051Recruiting
- Alliance for Multispecialty Research (AMR) - Wichita West /ID# 218040
- Cypress Medical Research Ctr /ID# 217093Recruiting
- Clinical Trials Management - Metairie /ID# 217054
- Clinical Trials Management, LLC - Covington /ID# 217291Recruiting
- Horizon Research Group /ID# 217100
- Praetorian Pharmaceutical Research /ID# 217159Recruiting
- Southern Clinical Research A /ID# 218028
- Women's Health Clinic /ID# 217205
- SBL Special Services LLC /ID# 224899
- Congressional OBGYN /ID# 245349Recruiting
- Continental Clinical Solutions /ID# 217053Recruiting
- NECCR Fall River LLC /ID# 217108
- Exordia Medical Research, Inc /ID# 217116Recruiting
- Great Lakes Research Group, Inc. /ID# 217099Recruiting
- Duplicate_Wayne State University, C.S. Mott Center /ID# 248422Recruiting
- Saginaw Valley Med Res Group /ID# 217296Recruiting
- Center for Reproductive Medicine and Robotic Surgery /ID# 223494
- Boeson Research - Great Falls /ID# 248560Recruiting
- Boeson Research - Missoula /ID# 248559Recruiting
- Womens Clinic of Lincoln, P.C. /ID# 217136
- Private practice: Dr. Rex G. Mabey JR /ID# 217134
- Dr. Nader and Associates M.D. P.C. /ID# 223571
- Cooper University Hospital /ID# 227208Recruiting
- Jersey Shore University Medical Center /ID# 217138Recruiting
- Rutgers Robert Wood Johnson /ID# 246933Recruiting
- Maimonides Medical Center /ID# 248493Recruiting
- Invision Health /ID# 218687
- Widewaters Gynecology /ID# 225621Recruiting
- Parkmed NYC /ID# 224333
- Columbia Univ Medical Center /ID# 217113Recruiting
- New York Presbyterian Hospital Weill Cornell Medical Center /ID# 224329
- Richmond OB/GYN Associates PC /ID# 224833Recruiting
- PMG Research of Charlotte /ID# 217224
- Tyron Medical Partners, PLLC /ID# 245286Recruiting
- Carolina Women's Research and Wellness Center /ID# 217133Recruiting
- Eastern Carolina Women's Centr /ID# 222358Recruiting
- PMG Research of Wilmington LLC /ID# 217097Recruiting
- Carolina Medical Trials - Winston-Salem /ID# 223002Recruiting
- Unified Women's Clinical Resea /ID# 217132
- Unified Women's Clinical Resea /ID# 218339
- Clinical Inquest Center Ltd /ID# 217961Recruiting
- Neuro-Behavioral Clinical Research, Inc. /ID# 224026Recruiting
- Seven Hills Clinical Research Group /ID# 224941Recruiting
- University of Cincinnati /ID# 217349
- MetroHealth Medical Center /ID# 224392Recruiting
- Central Ohio Clinical Research /ID# 217059
- HWC Women's Research Center /ID# 246619Recruiting
- Wright State Physicians, Inc /ID# 217272Recruiting
- Marion Ob/Gyn Inc. /ID# 244175Recruiting
- Univ Hosp Landerbrook /ID# 217065Recruiting
- AC Clinical Research /ID# 227356Recruiting
- Grube Gynecology /ID# 245132Recruiting
- Penn State University and Milton S. Hershey Medical Center /ID# 217057Recruiting
- University of Pennsylvania /ID# 217243Recruiting
- Reading hospital /ID# 223599Recruiting
- Vista Clinical Research /ID# 217151
- University Medical Group /ID# 217355Recruiting
- Vitalink Research - Greenville /ID# 217075
- Palmetto Clinical Research /ID# 217069
- Biocentric Healthcare Research /ID# 248582Recruiting
- Chattanooga Medical Research /ID# 217045Recruiting
- Research Memphis Associates, LLC /ID# 218022
- Access Clinical Trials, Inc. /ID# 217055Recruiting
- DCT - HCWC, LLC dba Discovery Clinical Trials /ID# 217095Recruiting
- Cedar Health Research /ID# 224407Recruiting
- Duplicate_The University of Texas Southwestern Medical Center /ID# 217048
- Signature Gyn Services /ID# 217299Recruiting
- Progressive Women's Health /ID# 248402Recruiting
- Willowbend Health and Wellness - Frisco /ID# 217354
- FMC Science, LLC - OB/GYN - Georgetown /ID# 218654
- University of Texas (UT) Health Women's Research Center at Memorial City /ID# 217362Recruiting
- OBGYN Medical Center Associates - Medical Center Office /ID# 245346Recruiting
- Centex Studies, Inc. - Houston /ID# 217357
- FMC Science /ID# 217047
- Maximos OB/GYN /ID# 229385Recruiting
- Advances in Health, Inc. /ID# 217220Recruiting
- Clinical Trials of Texas, Inc /ID# 217039
- VIP Trials /ID# 217261
- Discovery Clinical Trials-San Antonio /ID# 218547Recruiting
- Center of Reproductive Medicine /ID# 217241Recruiting
- Corner Canyon Obstetrics and G /ID# 217289Recruiting
- Physicians Research Options /ID# 217302Recruiting
- Highland Clinical Research /ID# 224052Recruiting
- Health Research of Hampton Roads, Inc. (HRHR) /ID# 217063
- Clinical Research Partners /ID# 217359Recruiting
- Virginia Women's Health Associates /ID# 227677Recruiting
- Clinical Trials Virginia, Inc. /ID# 217222
- Clinical Research Partners LLC - Richmond Forest Ave /ID# 217149
- Tidewater Clinical Research /ID# 217152Recruiting
- Seattle Clinical Research Center /ID# 217117Recruiting
- North Spokane Women's Health /ID# 217356
- Advanced Medical Concepts. PSC /ID# 221337Recruiting
- Henry A. Rodriguez Ginorio, MD /ID# 217233
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 217235Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Double-Blind: Placebo
Double-Blind: Elagolix
Double-Blind: Elagolix + COC
Participants will receive double-blind placebo on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.
Participants will receive double-blind Elagolix on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC (combined oral contraceptive) for 15 months. Participants will be followed-up for up to 12 months.
Participants will receive double-blind elagolix in combination with COC (combined oral contraceptive) on Day 1 for 3 months. At month 4, participants will receive open-label elagolix in combination with COC for 15 months. Participants will be followed-up for up to 12 months.