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CompletedPhase 3

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Key facts

Who runs it
AbbVie
Where
Albuquerque, Alpharetta, Atlanta, Austin, Bay City, Beavercreek, Birmingham, Blackfoot, Boca Raton, Brandon, Brooklyn, Cerritos, Champaign, Charlotte, Charlottesville, Chattanooga, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Covington, Dallas, DeBary, DeLand, Detroit, Dothan, Durham, Encinitas, Encino, Erie, Fairhope, Fall River, Fort Lauderdale, Fort Wayne, Fort Worth, Frisco, Garden Grove, Hershey, Hialeah, Houston, Huntington Beach, Huntsville, Idaho Falls, Jackson, Jacksonville, La Mesa, Lake Worth, Lampasas, Las Vegas, Los Angeles, Louisville, Loxahatchee Groves, Manhasset, Margate, Marrero, Memphis, Meridian, Mesa, Miami, Miami Lakes, Miami Springs, Middletown, Miramar, Mobile, Montebello, Nampa, Neptune City, New Orleans, New Port Richey, New York, Norfolk, North Chesterfield, Northridge, Oak Brook, Orange City, Orchard Park, Orlando, Pearland, Philadelphia, Plano, Portland, Raleigh, Richmond, Sacramento, Saginaw, Saint Cloud, San Antonio, San Diego, Santa Ana, Sarasota, Shawnee Mission, Shreveport, Simi Valley, Spartanburg, St Louis, St. Petersburg, Stuart, Suffolk, Sugar Land, Sunrise, Suwanee, Tampa, Toledo, Tucson, Tyler, Upland, Valley Village, Virginia Beach, Washington D.C., Webster, Wellington, West Palm Beach, Westminster, and Winston-Salem, United StatesSee the 155 sitesAlso in 1 other country, 2 sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
478 people enrolled
Started
13 Sept 2017
Ended
28 Jun 2024
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Elagolix
  • Estradiol /norethindrone acetate (E2/NETA)
  • E2/NETA Placebo
  • Elagolix Placebo
Record updated
22 July 2025

Who can take part

Age
18 years to 50 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Participant is a premenopausal female at the time of Screening
  • Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound [Transabdominal ultrasound (TAU) or transvaginal ultrasound (TVU)]
  • Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) > 80 mL during each of two screening menses as measured by the alkaline hematin method
  • Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose
  • Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology

Who cannot take part

  • Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed
  • Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder
  • Participant has history of osteoporosis or other metabolic bone disease
  • Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder)
  • Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis

Where in United States

Also in 1 other country, 2 sites

  • Bosque Women's Care /ID# 162606Albuquerque, United States
  • Lovelace Scientific Resources /ID# 163644Albuquerque, United States
  • Journey Medical Research Insti /ID# 160958Alpharetta, United States
  • Paramount Research Solutions /ID# 161557Alpharetta, United States
  • AGILE Clinical Research Trials /ID# 160941Atlanta, United States
  • Atlanta Women's Research Institute /ID# 160844Atlanta, United States
  • Medisense Inc /ID# 161494Atlanta, United States
  • Mount Vernon Clinical Res, LLC /ID# 161491Atlanta, United States
  • Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542Austin, United States
  • OBGYN North /ID# 203580Austin, United States
  • Duplicate_Great Lakes Research Group, Inc. /ID# 161511Bay City, United States
  • Clinical Inquest Center Ltd /ID# 160892Beavercreek, United States
  • Alabama Clinical Therapeutics /ID# 160835Birmingham, United States
  • Alabama Clinical Therapeutics /ID# 160927Birmingham, United States
  • Bingham Memorial Hospital /ID# 201130Blackfoot, United States
  • David Lubetkin MD LLC /ID# 203578Boca Raton, United States
  • Women's Health Partners /ID# 203577Boca Raton, United States
  • Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910Brandon, United States
  • SUNY Downstate Medical Center /ID# 160922Brooklyn, United States
  • Duplicate_Core Healthcare Group /ID# 160858Cerritos, United States
  • Women's Health Practice, LLC /ID# 161553Champaign, United States
  • DJL Clinical Research, PLLC /ID# 161548Charlotte, United States
  • Univ of Virgnia Medical center /ID# 166283Charlottesville, United States
  • Duplicate_Chattanooga Medical Research /ID# 160885Chattanooga, United States
  • WR-ClinSearch /ID# 160887Chattanooga, United States
  • Duplicate_University of Chicago /ID# 162667Chicago, United States
  • Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118Chicago, United States
  • Duplicate_CTI Clinical Research Center /ID# 160942Cincinnati, United States
  • Univ Hosp Cleveland /ID# 160953Cleveland, United States
  • Vista Clinical Research /ID# 160946Columbia, United States
  • Central Ohio Clinical Research /ID# 201162Columbus, United States
  • Duplicate_Optimed Research /ID# 165600Columbus, United States
  • Clinical Trials Management, LLC - Covington /ID# 160838Covington, United States
  • Clinical Trials Management, LLC - Covington /ID# 160893Covington, United States
  • Discovery Clinical Trials -HCWC /ID# 161543Dallas, United States
  • Duplicate_The University of Texas Southwestern Medical Center /ID# 161496Dallas, United States
  • Omega Research Maitland, LLC /ID# 160857DeBary, United States
  • Midland Florida Clinical Research Center /ID# 161487DeLand, United States
  • Wayne State University /ID# 160944Detroit, United States
  • Choice Research, LLC /ID# 161498Dothan, United States
  • Carolina Women's Research and Wellness Center /ID# 160914Durham, United States
  • Diagnamics Inc. /ID# 160950Encinitas, United States
  • HRC Fertility /ID# 161493Encino, United States
  • OB/GYN Associates of Erie /ID# 161541Erie, United States
  • Southern Women's Specialists PC /ID# 161531Fairhope, United States
  • Exordia Medical Research, Inc /ID# 160853Fall River, United States
  • KO Clinical Research, LLC /ID# 160928Fort Lauderdale, United States
  • Women's Health Advantage /ID# 161537Fort Wayne, United States
  • Baylor Scott & White /ID# 161515Fort Worth, United States
  • Willowbend Health and Wellness - Frisco /ID# 160954Frisco, United States
  • SC Clinical Research /ID# 164395Garden Grove, United States
  • Penn State University and Milton S. Hershey Medical Center /ID# 160896Hershey, United States
  • Sweet Hope Research Specialty Inc /ID# 163522Hialeah, United States
  • America's Adv. Wellness Center /ID# 167548Houston, United States
  • Centex Studies, Inc /ID# 163858Houston, United States
  • Centex Studies, Inc. - Houston /ID# 160917Houston, United States
  • Precision Research Institute, LLC /ID# 161554Houston, United States
  • The Ob/Gyn Center /ID# 165928Houston, United States
  • The Woman's Hospital of Texas /ID# 160959Houston, United States
  • UAG Innovation Women Research, /ID# 167415Houston, United States
  • Duplicate_Duplicate_Marvel Clinical Research /ID# 167297Huntington Beach, United States
  • E Squared Research /ID# 163645Huntsville, United States
  • Leavitt Womens Healthcare /ID# 163419Idaho Falls, United States
  • Womens Healthcare Assoc, DBA /ID# 160933Idaho Falls, United States
  • The Jackson Clinic, PA /ID# 162496Jackson, United States
  • Solutions Through Adv Rch /ID# 160935Jacksonville, United States
  • Grossmont Ctr Clin Research /ID# 165120La Mesa, United States
  • Altus Research, Inc /ID# 160912Lake Worth, United States
  • FMC Science /ID# 160886Lampasas, United States
  • Excel Clinical Research /ID# 165588Las Vegas, United States
  • Office of Edmond E. Pack, MD /ID# 162604Las Vegas, United States
  • Private practice: Dr. Rex G. Mabey JR /ID# 160915Las Vegas, United States
  • National Research Institute /ID# 160952Los Angeles, United States
  • Olympia Clinical Trials /ID# 201562Los Angeles, United States
  • Bluegrass Clinical Research /ID# 163485Louisville, United States
  • Wellington Anti-Aging Centre /ID# 203540Loxahatchee Groves, United States
  • Duplicate_Northwell Health System - Manhasset /ID# 201058Manhasset, United States
  • South Florida Wellness & Clinic /ID# 161535Margate, United States
  • Praetorian Pharmaceutical Research /ID# 161532Marrero, United States
  • Research Memphis Associates, LLC /ID# 160939Memphis, United States
  • Sonora Clinical Research /ID# 167610Meridian, United States
  • Mesa Obstetricians and Gynecologists /ID# 160955Mesa, United States
  • Healthcare Clinical Data, Inc /ID# 160888Miami, United States
  • Invictus Clinical Research Group,LLC /ID# 160925Miami, United States
  • Palmetto Professional Research /ID# 161442Miami, United States
  • Vista Health Research, LLC /ID# 163044Miami, United States
  • Duplicate_Precision Research Organization /ID# 161522Miami Lakes, United States
  • Ocean Blue Medical Research Center, Inc /ID# 161549Miami Springs, United States
  • Hilltop Obstetrics & Gynecology /ID# 203576Middletown, United States
  • Salom Tangir, LLC /ID# 162542Miramar, United States
  • Mobile, OBGYN P.C. /ID# 161530Mobile, United States
  • Women's Health Alliance of Mobile /ID# 161443Mobile, United States
  • Futura Research, Org /ID# 160924Montebello, United States
  • Asr, Llc /Id# 162179Nampa, United States
  • Jersey Shore University Medical Center /ID# 160916Neptune City, United States
  • Ochsner Baptist Medical Centre /ID# 161507New Orleans, United States
  • Women Under Study, LLC /ID# 163990New Orleans, United States
  • Advanced Research Institute, Inc /ID# 163748New Port Richey, United States
  • Columbia Univ Medical Center /ID# 161519New York, United States
  • Eastern Virginia Med School /ID# 160856Norfolk, United States
  • Clinical Research Partners /ID# 160929North Chesterfield, United States
  • Clinical Research Partners /ID# 160948North Chesterfield, United States
  • California Medical Research Associates /ID# 161481Northridge, United States
  • Alliance for Multispecialty Research, LLC /ID# 160932Oak Brook, United States
  • A Premier Medical Research of FL /ID# 201882Orange City, United States
  • Hamburg Regional Gynecology Gr /ID# 161427Orchard Park, United States
  • Clinical Associates of Orlando /ID# 160889Orlando, United States
  • Advances in Health, Inc. /ID# 160930Pearland, United States
  • DUP_Thomas Jefferson University /ID# 200304Philadelphia, United States
  • University of Pennsylvania /ID# 160936Philadelphia, United States
  • ClinRx Research, LLC /ID# 201170Plano, United States
  • Oregon Medical Research Center /ID# 161514Portland, United States
  • Unified Women's Clinical Resea /ID# 163014Raleigh, United States
  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490Raleigh, United States
  • Clinical Trials Virginia, Inc. /ID# 160943Richmond, United States
  • Northern California Research /ID# 161561Sacramento, United States
  • Saginaw Valley Med Res Group /ID# 160840Saginaw, United States
  • Valley OB-Gyn Clinic - Saginaw /ID# 203579Saginaw, United States
  • Oncova Clinical Research, Inc. /ID# 160937Saint Cloud, United States
  • Clinical Trials of Texas, Inc /ID# 161510San Antonio, United States
  • VIP Trials /ID# 161546San Antonio, United States
  • MD Strategies Research Centers /ID# 161544San Diego, United States
  • Precision Research Institute - San Diego /ID# 163069San Diego, United States
  • Health care Affiliates Medical Group /ID# 163324Santa Ana, United States
  • Physician Care Clin. Res., LLC /ID# 161547Sarasota, United States
  • Womens & Family Care, LLC dba /ID# 160890Shawnee Mission, United States
  • Willis-Knighton Pediatric GI S /ID# 161534Shreveport, United States
  • Alta California Medical Group /ID# 163564Simi Valley, United States
  • VitaLink Research-Spartanburg /ID# 164592Spartanburg, United States
  • Quad Clinical Research, LLC /ID# 200943St Louis, United States
  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913St. Petersburg, United States
  • Treasure Coast Research /ID# 161824Stuart, United States
  • Specialists for Women /ID# 201129Suffolk, United States
  • Houston Ctr for Clin Research /ID# 160837Sugar Land, United States
  • Discovery Clinical Research /ID# 160891Sunrise, United States
  • Precision Clinical Research /ID# 165377Sunrise, United States
  • Duplicate_Atlanta Gynecology Research Institute /ID# 160851Suwanee, United States
  • GCP Clinical Research, LLC /ID# 164593Tampa, United States
  • Jedidiah Clinical Research /ID# 167114Tampa, United States
  • University of South Florida- Neuroscience Institute /ID# 160960Tampa, United States
  • University of Toledo /ID# 160923Toledo, United States
  • Eclipse Clinical Research /ID# 161516Tucson, United States
  • Noble Clinical Research /ID# 166949Tucson, United States
  • Vision's Clinical Research-Tucson /ID# 161508Tucson, United States
  • The Univ Texas HSC at Tyler /ID# 161533Tyler, United States
  • Upland Clinical Research /ID# 164528Upland, United States
  • Bayview Research Group LLC /ID# 161484Valley Village, United States
  • Tidewater Clinical Research /ID# 160949Virginia Beach, United States
  • Emerson Clinical Research Inst /ID# 162181Washington D.C., United States
  • James A. Simon, MD, PC /ID# 160931Washington D.C., United States
  • Center of Reproductive Medicine /ID# 162498Webster, United States
  • Virtus Research Consultants, LLC /ID# 160855Wellington, United States
  • Comprehensive Clinical Trials LLC /ID# 161479West Palm Beach, United States
  • Advanced RX Clinical Research /ID# 161599Westminster, United States
  • Unified Women's Clinical Resea /ID# 160957Winston-Salem, United States

About the trial

What the trial wants to find out

This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.

The 2 groups in the trial

  • Elagolix plus estradiol (E2)/norethindrone acetate (NETA)Treatment being tested

    Treatment: Elagolix and Estradiol /norethindrone acetate (E2/NETA)

  • PlaceboPlacebo, for comparison

    Treatment: E2/NETA Placebo and Elagolix Placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Record updated
22 July 2025