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
- Conditions
- Uterine FibroidsHeavy Menstrual Bleeding
- Interventions
- Registration Number
- NCT03271489
- Lead Sponsor
- AbbVie
- Brief Summary
This is 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 is double-blinded in the first year and an open-label for the next three years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 478
- 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) and 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.
- 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 clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Elagolix Placebo Placebo Elagolix plus estradiol (E2)/norethindrone acetate (NETA) Elagolix Elagolix plus estradiol (E2)/norethindrone acetate (NETA) Placebo E2/NETA Placebo Placebo Elagolix plus estradiol (E2)/norethindrone acetate (NETA) E2/NETA Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Month 60 An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Change in Bone Mineral Density (BMD) From Baseline through Month 60 Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).
Trial Locations
- Locations (157)
Exordia Medical Research, Inc /ID# 160853
🇺🇸Fall River, Massachusetts, United States
Health care Affiliates Medical Group /ID# 163324
🇺🇸Santa Ana, California, United States
Duplicate_Northwell Health System - Manhasset /ID# 201058
🇺🇸Manhasset, New York, United States
Discovery Clinical Trials -HCWC /ID# 161543
🇺🇸Dallas, Texas, United States
Houston Ctr for Clin Research /ID# 160837
🇺🇸Sugar Land, Texas, United States
Mount Vernon Clinical Res, LLC /ID# 161491
🇺🇸Atlanta, Georgia, United States
Atlanta Women's Research Institute /ID# 160844
🇺🇸Atlanta, Georgia, United States
Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118
🇺🇸Chicago, Illinois, United States
Duplicate_University of Chicago /ID# 162667
🇺🇸Chicago, Illinois, United States
Central Ohio Clinical Research /ID# 201162
🇺🇸Columbus, Ohio, United States
Invictus Clinical Research Group,LLC /ID# 160925
🇺🇸Miami, Florida, United States
Healthcare Clinical Data, Inc /ID# 160888
🇺🇸Miami, Florida, United States
Palmetto Professional Research /ID# 161442
🇺🇸Miami, Florida, United States
Vista Health Research, LLC /ID# 163044
🇺🇸Miami, Florida, United States
Centex Studies, Inc /ID# 163858
🇺🇸Houston, Texas, United States
Centex Studies, Inc. - Houston /ID# 160917
🇺🇸Houston, Texas, United States
UAG Innovation Women Research, /ID# 167415
🇺🇸Houston, Texas, United States
America's Adv. Wellness Center /ID# 167548
🇺🇸Houston, Texas, United States
Private practice: Dr. Rex G. Mabey JR /ID# 160915
🇺🇸Las Vegas, Nevada, United States
Wayne State University /ID# 160944
🇺🇸Detroit, Michigan, United States
Carolina Women's Research and Wellness Center /ID# 160914
🇺🇸Durham, North Carolina, United States
Duplicate_CTI Clinical Research Center /ID# 160942
🇺🇸Cincinnati, Ohio, United States
Clinical Trials of Texas, Inc /ID# 161510
🇺🇸San Antonio, Texas, United States
Precision Research Institute - San Diego /ID# 163069
🇺🇸San Diego, California, United States
VIP Trials /ID# 161546
🇺🇸San Antonio, Texas, United States
Womens & Family Care, LLC dba /ID# 160890
🇺🇸Shawnee Mission, Kansas, United States
MD Strategies Research Centers /ID# 161544
🇺🇸San Diego, California, United States
Alabama Clinical Therapeutics /ID# 160927
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics /ID# 160835
🇺🇸Birmingham, Alabama, United States
Emerson Clinical Research Inst /ID# 162181
🇺🇸Washington, District of Columbia, United States
Mesa Obstetricians and Gynecologists /ID# 160955
🇺🇸Mesa, Arizona, United States
Willis-Knighton Pediatric GI S /ID# 161534
🇺🇸Shreveport, Louisiana, United States
Research Memphis Associates, LLC /ID# 160939
🇺🇸Memphis, Tennessee, United States
Noble Clinical Research /ID# 166949
🇺🇸Tucson, Arizona, United States
VitaLink Research-Spartanburg /ID# 164592
🇺🇸Spartanburg, South Carolina, United States
Jersey Shore University Medical Center /ID# 160916
🇺🇸Neptune, New Jersey, United States
Vista Clinical Research /ID# 160946
🇺🇸Columbia, South Carolina, United States
Excel Clinical Research /ID# 165588
🇺🇸Las Vegas, Nevada, United States
The Jackson Clinic, PA /ID# 162496
🇺🇸Jackson, Tennessee, United States
Oregon Medical Research Center /ID# 161514
🇺🇸Portland, Oregon, United States
GCP Clinical Research, LLC /ID# 164593
🇺🇸Tampa, Florida, United States
University of South Florida- Neuroscience Institute /ID# 160960
🇺🇸Tampa, Florida, United States
Jedidiah Clinical Research /ID# 167114
🇺🇸Tampa, Florida, United States
Choice Research, LLC /ID# 161498
🇺🇸Dothan, Alabama, United States
E Squared Research /ID# 163645
🇺🇸Huntsville, Alabama, United States
Mobile, OBGYN P.C. /ID# 161530
🇺🇸Mobile, Alabama, United States
Southern Women's Specialists PC /ID# 161531
🇺🇸Fairhope, Alabama, United States
Women's Health Alliance of Mobile /ID# 161443
🇺🇸Mobile, Alabama, United States
Vision's Clinical Research-Tucson /ID# 161508
🇺🇸Tucson, Arizona, United States
Duplicate_Core Healthcare Group /ID# 160858
🇺🇸Cerritos, California, United States
Eclipse Clinical Research /ID# 161516
🇺🇸Tucson, Arizona, United States
Diagnamics Inc. /ID# 160950
🇺🇸Encinitas, California, United States
SC Clinical Research /ID# 164395
🇺🇸Garden Grove, California, United States
National Research Institute /ID# 160952
🇺🇸Los Angeles, California, United States
HRC Fertility /ID# 161493
🇺🇸Encino, California, United States
Grossmont Ctr Clin Research /ID# 165120
🇺🇸La Mesa, California, United States
Olympia Clinical Trials /ID# 201562
🇺🇸Los Angeles, California, United States
Duplicate_Duplicate_Marvel Clinical Research /ID# 167297
🇺🇸Huntington Beach, California, United States
California Medical Research Associates /ID# 161481
🇺🇸Northridge, California, United States
Futura Research, Org /ID# 160924
🇺🇸Montebello, California, United States
Advanced RX Clinical Research /ID# 161599
🇺🇸Westminster, California, United States
Alta California Medical Group /ID# 163564
🇺🇸Simi Valley, California, United States
Bayview Research Group LLC /ID# 161484
🇺🇸Valley Village, California, United States
Upland Clinical Research /ID# 164528
🇺🇸Upland, California, United States
James A. Simon, MD, PC /ID# 160931
🇺🇸Washington, District of Columbia, United States
Omega Research Maitland, LLC /ID# 160857
🇺🇸DeBary, Florida, United States
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910
🇺🇸Brandon, Florida, United States
Women's Health Partners /ID# 203577
🇺🇸Boca Raton, Florida, United States
David Lubetkin MD LLC /ID# 203578
🇺🇸Boca Raton, Florida, United States
Midland Florida Clinical Research Center /ID# 161487
🇺🇸DeLand, Florida, United States
KO Clinical Research, LLC /ID# 160928
🇺🇸Fort Lauderdale, Florida, United States
Sweet Hope Research Specialty Inc /ID# 163522
🇺🇸Hialeah, Florida, United States
Solutions Through Adv Rch /ID# 160935
🇺🇸Jacksonville, Florida, United States
Altus Research, Inc /ID# 160912
🇺🇸Lake Worth, Florida, United States
Wellington Anti-Aging Centre /ID# 203540
🇺🇸Loxahatchee Groves, Florida, United States
South Florida Wellness & Clinic /ID# 161535
🇺🇸Margate, Florida, United States
Ocean Blue Medical Research Center, Inc /ID# 161549
🇺🇸Miami Springs, Florida, United States
Duplicate_Precision Research Organization /ID# 161522
🇺🇸Miami Lakes, Florida, United States
Salom Tangir, LLC /ID# 162542
🇺🇸Miramar, Florida, United States
Advanced Research Institute, Inc /ID# 163748
🇺🇸New Port Richey, Florida, United States
A Premier Medical Research of FL /ID# 201882
🇺🇸Orange City, Florida, United States
Oncova Clinical Research, Inc. /ID# 160937
🇺🇸Saint Cloud, Florida, United States
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913
🇺🇸Saint Petersburg, Florida, United States
Treasure Coast Research /ID# 161824
🇺🇸Stuart, Florida, United States
Precision Clinical Research /ID# 165377
🇺🇸Sunrise, Florida, United States
Discovery Clinical Research /ID# 160891
🇺🇸Sunrise, Florida, United States
Virtus Research Consultants, LLC /ID# 160855
🇺🇸Wellington, Florida, United States
Comprehensive Clinical Trials LLC /ID# 161479
🇺🇸West Palm Beach, Florida, United States
Journey Medical Research Insti /ID# 160958
🇺🇸Alpharetta, Georgia, United States
Paramount Research Solutions /ID# 161557
🇺🇸Alpharetta, Georgia, United States
Medisense Inc /ID# 161494
🇺🇸Atlanta, Georgia, United States
Bingham Memorial Hospital /ID# 201130
🇺🇸Blackfoot, Idaho, United States
AGILE Clinical Research Trials /ID# 160941
🇺🇸Atlanta, Georgia, United States
Duplicate_Atlanta Gynecology Research Institute /ID# 160851
🇺🇸Suwanee, Georgia, United States
Sonora Clinical Research /ID# 167610
🇺🇸Meridian, Idaho, United States
Leavitt Womens Healthcare /ID# 163419
🇺🇸Idaho Falls, Idaho, United States
Womens Healthcare Assoc, DBA /ID# 160933
🇺🇸Idaho Falls, Idaho, United States
Asr, Llc /Id# 162179
🇺🇸Nampa, Idaho, United States
Women's Health Advantage /ID# 161537
🇺🇸Fort Wayne, Indiana, United States
Alliance for Multispecialty Research, LLC /ID# 160932
🇺🇸Oak Brook, Illinois, United States
Women's Health Practice, LLC /ID# 161553
🇺🇸Champaign, Illinois, United States
Clinical Trials Management, LLC - Covington /ID# 160838
🇺🇸Covington, Louisiana, United States
Praetorian Pharmaceutical Research /ID# 161532
🇺🇸Marrero, Louisiana, United States
Clinical Trials Management, LLC - Covington /ID# 160893
🇺🇸Covington, Louisiana, United States
Duplicate_Great Lakes Research Group, Inc. /ID# 161511
🇺🇸Bay City, Michigan, United States
Saginaw Valley Med Res Group /ID# 160840
🇺🇸Saginaw, Michigan, United States
Valley OB-Gyn Clinic - Saginaw /ID# 203579
🇺🇸Saginaw, Michigan, United States
Quad Clinical Research, LLC /ID# 200943
🇺🇸Saint Louis, Missouri, United States
Office of Edmond E. Pack, MD /ID# 162604
🇺🇸Las Vegas, Nevada, United States
SUNY Downstate Medical Center /ID# 160922
🇺🇸Brooklyn, New York, United States
Hamburg Regional Gynecology Gr /ID# 161427
🇺🇸Orchard Park, New York, United States
Columbia Univ Medical Center /ID# 161519
🇺🇸New York, New York, United States
DJL Clinical Research, PLLC /ID# 161548
🇺🇸Charlotte, North Carolina, United States
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490
🇺🇸Raleigh, North Carolina, United States
Clinical Inquest Center Ltd /ID# 160892
🇺🇸Beavercreek, Ohio, United States
Univ Hosp Cleveland /ID# 160953
🇺🇸Cleveland, Ohio, United States
Duplicate_Optimed Research /ID# 165600
🇺🇸Columbus, Ohio, United States
Hilltop Obstetrics & Gynecology /ID# 203576
🇺🇸Middletown, Ohio, United States
University of Toledo /ID# 160923
🇺🇸Toledo, Ohio, United States
OB/GYN Associates of Erie /ID# 161541
🇺🇸Erie, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 160896
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 160936
🇺🇸Philadelphia, Pennsylvania, United States
DUP_Thomas Jefferson University /ID# 200304
🇺🇸Philadelphia, Pennsylvania, United States
WR-ClinSearch /ID# 160887
🇺🇸Chattanooga, Tennessee, United States
Duplicate_The University of Texas Southwestern Medical Center /ID# 161496
🇺🇸Dallas, Texas, United States
The Woman's Hospital of Texas /ID# 160959
🇺🇸Houston, Texas, United States
Baylor Scott & White /ID# 161515
🇺🇸Fort Worth, Texas, United States
Willowbend Health and Wellness - Frisco /ID# 160954
🇺🇸Frisco, Texas, United States
The Ob/Gyn Center /ID# 165928
🇺🇸Houston, Texas, United States
Precision Research Institute, LLC /ID# 161554
🇺🇸Houston, Texas, United States
ClinRx Research, LLC /ID# 201170
🇺🇸Plano, Texas, United States
FMC Science /ID# 160886
🇺🇸Lampasas, Texas, United States
Advances in Health, Inc. /ID# 160930
🇺🇸Pearland, Texas, United States
The Univ Texas HSC at Tyler /ID# 161533
🇺🇸Tyler, Texas, United States
Center of Reproductive Medicine /ID# 162498
🇺🇸Webster, Texas, United States
Univ of Virgnia Medical center /ID# 166283
🇺🇸Charlottesville, Virginia, United States
Clinical Research Partners /ID# 160948
🇺🇸North Chesterfield, Virginia, United States
Eastern Virginia Med School /ID# 160856
🇺🇸Norfolk, Virginia, United States
Clinical Research Partners /ID# 160929
🇺🇸North Chesterfield, Virginia, United States
Specialists for Women /ID# 201129
🇺🇸Suffolk, Virginia, United States
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862
🇵🇷San Juan, Puerto Rico
Henry A. Rodriguez Ginorio, MD /ID# 160861
🇵🇷San Juan, Puerto Rico
Tidewater Clinical Research /ID# 160949
🇺🇸Virginia Beach, Virginia, United States
Physician Care Clin. Res., LLC /ID# 161547
🇺🇸Sarasota, Florida, United States
Duplicate_Chattanooga Medical Research /ID# 160885
🇺🇸Chattanooga, Tennessee, United States
Unified Women's Clinical Resea /ID# 163014
🇺🇸Raleigh, North Carolina, United States
Clinical Associates of Orlando /ID# 160889
🇺🇸Orlando, Florida, United States
Northern California Research /ID# 161561
🇺🇸Sacramento, California, United States
Bluegrass Clinical Research /ID# 163485
🇺🇸Louisville, Kentucky, United States
Ochsner Baptist Medical Centre /ID# 161507
🇺🇸New Orleans, Louisiana, United States
OBGYN North /ID# 203580
🇺🇸Austin, Texas, United States
Clinical Trials Virginia, Inc. /ID# 160943
🇺🇸Richmond, Virginia, United States
Women Under Study, LLC /ID# 163990
🇺🇸New Orleans, Louisiana, United States
Unified Women's Clinical Resea /ID# 160957
🇺🇸Winston-Salem, North Carolina, United States
Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542
🇺🇸Austin, Texas, United States
Lovelace Scientific Resources /ID# 163644
🇺🇸Albuquerque, New Mexico, United States
Bosque Women's Care /ID# 162606
🇺🇸Albuquerque, New Mexico, United States