Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
1 other identifier
interventional
378
2 countries
105
Brief Summary
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2016
Typical duration for phase_3
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2016
CompletedFirst Submitted
Initial submission to the registry
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2019
CompletedResults Posted
Study results publicly available
June 30, 2020
CompletedJuly 13, 2021
July 1, 2021
2 years
February 22, 2016
June 12, 2020
July 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Meeting the Criteria for Responder
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Secondary Outcomes (6)
Change From Baseline in MBL Volume to the Final Month
Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Percentage of Participants With Suppression of Bleeding at the Final Month
Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Change From Baseline in MBL Volume to Month 6
Month 0 (Baseline), Month 6
Change From Baseline in MBL Volume to Month 3
Month 0 (Baseline), Month 3
Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6
Month 0 (Baseline), Month 6
- +1 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (QD)
Elagolix
EXPERIMENTALElagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix + E2/NETA
EXPERIMENTALElagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Interventions
Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
Eligibility Criteria
You may qualify if:
- Subject is a premenopausal female at the time of Screening.
- Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
- Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
- Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
- Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.
You may not qualify if:
- Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
- Subject has history of osteoporosis or other metabolic bone disease.
- Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
- Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
- Subject 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 injectable (for occasional use) corticosteroids are allowed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (105)
Alabama Clinical Therapeutics, LLC /ID# 152258
Birmingham, Alabama, 35235-3430, United States
Choice Research, LLC /ID# 150988
Dothan, Alabama, 36303, United States
Brown, Pearson, Guepet Gynecology /ID# 151020
Fairhope, Alabama, 36532, United States
Mobile, Ob-Gyn, P.C. /ID# 144294
Mobile, Alabama, 36608, United States
Mesa Obstetricians and Gynecol /ID# 149139
Mesa, Arizona, 85209, United States
Visions Clinical Research-Tucs /ID# 151017
Tucson, Arizona, 85712, United States
Core Healthcare Group /ID# 151016
Cerritos, California, 90703, United States
Diagnamics Inc. /ID# 152469
Encinitas, California, 92024, United States
HCP Clinical Research LLC /ID# 154434
Huntington Beach, California, 92646, United States
Alliance Research Centers /ID# 149752
Laguna Hills, California, 92653-3621, United States
University of California, Los Angeles /ID# 149760
Los Angeles, California, 90095, United States
Futura Research, Inc. /ID# 149759
Norwalk, California, 90650, United States
Farid Yasharpour MD Medical Co /ID# 149770
San Fernando, California, 91340, United States
Clinical Trial Investigators /ID# 152470
Tustin, California, 92780, United States
Bayview Research Group LLC /ID# 153799
Valley Village, California, 91607, United States
Emerson Clinical Research Inst /ID# 152348
Washington D.C., District of Columbia, 20011, United States
Ideal Clinical Research Inc. /ID# 149757
Aventura, Florida, 33180, United States
Seffner Premier Health Care, P /ID# 167480
Brandon, Florida, 33510, United States
Olympian Clinical Research /ID# 149756
Clearwater, Florida, 33756, United States
KO Clinical Research, LLC /ID# 144299
Fort Lauderdale, Florida, 33316, United States
University of Florida /ID# 149751
Gainesville, Florida, 32610, United States
Solutions Through Adv Rch /ID# 151021
Jacksonville, Florida, 32256, United States
Meridien Research /ID# 167100
Kenneth City, Florida, 33709-3113, United States
Invictus Clinical Research Group,LLC /ID# 141859
Miami, Florida, 33144, United States
Precision Research Org, LLC /ID# 144335
Miami Lakes, Florida, 33016-1501, United States
Suncoast Clinical Research /ID# 149765
New Port Richey, Florida, 34652, United States
All Wmns HC of West Broward /ID# 144298
Plantation, Florida, 33324, United States
Oncova Clinical Research, Inc. /ID# 149764
Saint Cloud, Florida, 34769, United States
Physician Care Clin. Res., LLC /ID# 149766
Sarasota, Florida, 34239, United States
Qps-Mra, Llc /Id# 144325
South Miami, Florida, 33143, United States
Martin Health System Center /ID# 152263
Stuart, Florida, 34994, United States
University of South Florida /ID# 149754
Tampa, Florida, 33612, United States
Axcess Medical Research /ID# 149769
Wellington, Florida, 33414, United States
Virtus Research Consultant,LLC /ID# 144296
Wellington, Florida, 33414, United States
Paramount Research Solutions /ID# 149291
Alpharetta, Georgia, 30005, United States
Agile Clinical Research Trials /ID# 167074
Atlanta, Georgia, 30328, United States
Mount Vernon Clinical Res, LLC /ID# 144297
Atlanta, Georgia, 30328, United States
Atlanta Women's Research Inst /ID# 144303
Atlanta, Georgia, 30342, United States
Masters of Clinical Research, Inc. /ID# 167400
Augusta, Georgia, 30909, United States
Georgia Regents University /ID# 144295
Augusta, Georgia, 30912, United States
Meridian Clinical Research, LLC /ID# 149144
Savannah, Georgia, 31406-2675, United States
Gyn-Care, Inc. /ID# 149341
Smyrna, Georgia, 30080, United States
Atlanta Gynecology Research Institute /ID# 151014
Suwanee, Georgia, 30024-7159, United States
Womens Healthcare Assoc, DBA /ID# 149762
Idaho Falls, Idaho, 83404, United States
Advanced Clinical Research /ID# 149767
Meridian, Idaho, 83642, United States
University of Chicago /ID# 152257
Chicago, Illinois, 60637-1443, United States
Affinity Clinical Research /ID# 167119
Oak Brook, Illinois, 60523, United States
Center for Women's Research, Inc /ID# 144300
Palos Heights, Illinois, 60463-1440, United States
Women's Health Advantage /ID# 144301
Fort Wayne, Indiana, 46825, United States
The Iowa Clinic /ID# 150105
West Des Moines, Iowa, 50266, United States
PRN Professional Research Network of Kansas, LLC /ID# 152265
Wichita, Kansas, 67205, United States
Bluegrass Clinical Research /ID# 150103
Louisville, Kentucky, 40291, United States
Clinical Trials Management, LLC - Covington /ID# 144314
Covington, Louisiana, 70433, United States
Women Under Study, LLC /ID# 144312
New Orleans, Louisiana, 70125-1923, United States
Baltimore Suburban Health /ID# 154638
Baltimore, Maryland, 21208, United States
Womens Health Center /ID# 154209
Glen Burnie, Maryland, 21063, United States
Maryland Ctr for Sexual Health /ID# 149778
Lutherville, Maryland, 21093, United States
NECCR Fall River LLC /ID# 149584
Fall River, Massachusetts, 02720-2972, United States
Saginaw Valley Med Res Group /ID# 149768
Saginaw, Michigan, 48604, United States
Accent Clinical Trials /ID# 149753
Las Vegas, Nevada, 89106-4017, United States
Jersey Shore University Medical Center /ID# 149779
Neptune City, New Jersey, 07753-4859, United States
Rowan University SOM /ID# 152697
Stratford, New Jersey, 08084, United States
SUNY Downstate Medical Center /ID# 144311
Brooklyn, New York, 11203, United States
Manhattan Medical Research /ID# 167077
New York, New York, 10016-6023, United States
Weill Cornell Medicine /ID# 149585
New York, New York, 10032-3725, United States
Montefiore Medical Center /ID# 149582
The Bronx, New York, 10461, United States
Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587
Fayetteville, North Carolina, 28304, United States
Unified Women's Clinical Research-Greensboro /ID# 149588
Greensboro, North Carolina, 27408, United States
Pinewest Ob-Gyn, Inc. /ID# 145671
High Point, North Carolina, 27262, United States
Eastern Carolina Women's Centr /ID# 144309
New Bern, North Carolina, 28562, United States
Wake Research Associates, LLC /ID# 144307
Raleigh, North Carolina, 27612, United States
Clinical Inquest Center Ltd /ID# 148728
Beavercreek, Ohio, 45432, United States
CTI Clinical Research Center /ID# 149761
Cincinnati, Ohio, 45212, United States
The Christ Hospital /ID# 150104
Cincinnati, Ohio, 45219, United States
Alpha Research Associates LLC /ID# 152471
Dayton, Ohio, 45417, United States
Comprehensive Womens Care /ID# 144306
Westerville, Ohio, 43081, United States
Family Medical Associates /ID# 145668
Levittown, Pennsylvania, 19056, United States
University of Pennsylvania /ID# 149586
Philadelphia, Pennsylvania, 19104-5502, United States
Clinical Research of Philadelphia, LLC /ID# 151015
Philadelphia, Pennsylvania, 19114, United States
Reading Hosp Clncl Trials Ofc /ID# 149583
West Reading, Pennsylvania, 19611, United States
Holston Medical Group /ID# 149763
Bristol, Tennessee, 37620-7346, United States
Chattanooga Medical Research /ID# 145667
Chattanooga, Tennessee, 37404, United States
Chattanooga Women for Women /ID# 167051
Hixson, Tennessee, 37343-3992, United States
The Jackson Clinic, PA /ID# 145670
Jackson, Tennessee, 38305, United States
The Womens Physician Group /ID# 144317
Memphis, Tennessee, 38104, United States
Access Clinical Trials, Inc. /ID# 167333
Nashville, Tennessee, 37203, United States
Lotus Gynecology /ID# 149140
Austin, Texas, 78703-1448, United States
Inquest Clinical Research /ID# 149755
Baytown, Texas, 77521-2415, United States
Texas Health Presbyterian Hosp /ID# 149142
Dallas, Texas, 75231, United States
Baylor College of Medicine /ID# 149141
Houston, Texas, 77030-3411, United States
The Woman's Hospital of Texas /ID# 144319
Houston, Texas, 77054, United States
Centex Studies, Inc. - Houston /ID# 150106
Houston, Texas, 77058, United States
BI Research Center /ID# 149143
Houston, Texas, 77084, United States
FMC Science /ID# 151802
Lampasas, Texas, 76550, United States
Willowbend Health and Wellness /ID# 144318
Plano, Texas, 75035, United States
Clinical Trials of Texas,Inc. /ID# 144322
San Antonio, Texas, 78229, United States
Center of Reproductive Medicin /ID# 167235
Webster, Texas, 77598, United States
Southampton Women's Health /ID# 152325
Franklin, Virginia, 23851, United States
Tidewater Physicians for Women /ID# 144321
Norfolk, Virginia, 23502, United States
Clinical Research Partners, LLC /ID# 144310
Richmond, Virginia, 23220-4459, United States
Alliance Womens Health /ID# 152468
Richmond, Virginia, 23226-1930, United States
Zain Research /ID# 151018
Richland, Washington, 99352, United States
Virginia Mason Medical Center /ID# 149758
Seattle, Washington, 98101, United States
Medicor Research Inc. /ID# 153406
Greater Sudbury, Ontario, P3A 1W8, Canada
Victory Reproductive Care /ID# 150247
Windsor, Ontario, N8W 5R7, Canada
Related Publications (6)
Simon JA, Stewart EA, Jewell S, Li M, Snabes MC. Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials. F S Rep. 2024 Jun 14;5(3):285-295. doi: 10.1016/j.xfre.2024.06.002. eCollection 2024 Sep.
PMID: 39381651DERIVEDBeck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8.
PMID: 34878624DERIVEDStewart EA, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg EC, Gillispie-Bell V, Imudia AN, Liu R, Kim JH, Al-Hendy A. Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids. J Womens Health (Larchmt). 2022 May;31(5):698-705. doi: 10.1089/jwh.2021.0152. Epub 2021 Sep 28.
PMID: 34582715DERIVEDMuneyyirci-Delale O, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg E, Gillispie V, Hurtado S, Kim JH, Wang A, Wang H, Stewart EA. Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis. F S Rep. 2021 May 26;2(3):338-346. doi: 10.1016/j.xfre.2021.05.004. eCollection 2021 Sep.
PMID: 34553161DERIVEDBeck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8.
PMID: 33650259DERIVEDSchlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Feinberg EC, Hurtado SM, Kim J, Liu R, Mabey RG Jr, Owens CD, Poindexter A, Puscheck EE, Rodriguez-Ginorio H, Simon JA, Soliman AM, Stewart EA, Watts NB, Muneyyirci-Delale O. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020 Jan 23;382(4):328-340. doi: 10.1056/NEJMoa1904351.
PMID: 31971678DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
February 25, 2016
Study Start
February 3, 2016
Primary Completion
February 14, 2018
Study Completion
January 23, 2019
Last Updated
July 13, 2021
Results First Posted
June 30, 2020
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.