An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
1 other identifier
interventional
433
3 countries
124
Brief Summary
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
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 Sep 2016
Typical duration for phase_3
124 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
September 14, 2016
CompletedFirst Submitted
Initial submission to the registry
September 24, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2019
CompletedResults Posted
Study results publicly available
June 30, 2020
CompletedJuly 13, 2021
July 1, 2021
1.6 years
September 24, 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 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.
From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)
Secondary Outcomes (4)
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
Percentage of Participants With Suppression of Bleeding at the Final Month
Final Month of Treatment Period (up through Month 6)
Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period
Month 6
Study Arms (2)
Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)
EXPERIMENTALElagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD)
Elagolix
EXPERIMENTALElagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Interventions
film-coated tablets
Eligibility Criteria
You may qualify if:
- Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
- Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
- Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
- Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.
You may not qualify if:
- Participant met criteria for removal from therapy in her respective Pivotal Study.
- Participant is planning a pregnancy within the next 18 months.
- Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
- Participant has any new medical conditions that may be unsuitable for participation.
- Participant is using any systemic corticosteroids for over 14 days 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 (124)
Alabama Clinical Therapeutics, LLC /ID# 153217
Birmingham, Alabama, 35235-3430, United States
Alabama Clinical Therapeutics, LLC /ID# 153336
Birmingham, Alabama, 35235-3430, United States
Choice Research, LLC /ID# 153492
Dothan, Alabama, 36303, United States
Brown, Pearson, Guepet Gynecology /ID# 153278
Fairhope, Alabama, 36532, United States
University of South Alabama /ID# 153415
Mobile, Alabama, 36604-3302, United States
Mobile, Ob-Gyn, P.C. /ID# 153442
Mobile, Alabama, 36608, United States
Mesa Obstetricians and Gynecol /ID# 153269
Mesa, Arizona, 85209, United States
Core Healthcare Group /ID# 153282
Cerritos, California, 90703, United States
Diagnamics Inc. /ID# 153347
Encinitas, California, 92024, United States
Grossmont Ctr Clin Research /ID# 153324
La Mesa, California, 91942, United States
Futura Research, Inc. /ID# 153345
Norwalk, California, 90650, United States
Farid Yasharpour MD Medical Co /ID# 153482
San Fernando, California, 91340, United States
Advanced Women's Health Institution /ID# 153401
Greenwood Village, Colorado, 80111, United States
Medstar Health Research Institute /ID# 153321
Washington D.C., District of Columbia, 20010, United States
Emerson Clinical Research Inst /ID# 162755
Washington D.C., District of Columbia, 20011, United States
James A. Simon, MD, PC /ID# 153323
Washington D.C., District of Columbia, 20036, United States
Helix Biomedics, LLC /ID# 153440
Boynton Beach, Florida, 33436-6634, United States
Brandon Premier Health Care, PA /ID# 165791
Brandon, Florida, 33510-3107, United States
Florida Fertility Institute /ID# 153308
Clearwater, Florida, 33759, United States
Omega Research Consultants, LLC /ID# 153381
DeBary, Florida, 32713-2260, United States
KO Clinical Research, LLC /ID# 153198
Fort Lauderdale, Florida, 33316, United States
Clinical Physiology Assoc. /ID# 153444
Fort Myers, Florida, 33916, United States
Solutions Through Adv Rch /ID# 153283
Jacksonville, Florida, 32256, United States
Meridien Research /ID# 153310
Kenneth City, Florida, 33709-3113, United States
Altus Research, Inc /ID# 153307
Lake Worth, Florida, 33461, United States
South Florida Wellness & Clinic /ID# 153420
Margate, Florida, 33063, United States
LCC Medical Research Institute /ID# 153296
Miami, Florida, 33126, United States
Invictus Clinical Research Group,LLC /ID# 153196
Miami, Florida, 33144, United States
Healthcare Clinical Data, Inc /ID# 153425
Miami, Florida, 33161, United States
Ocean Blue Med Research Ctr /ID# 153225
Miami, Florida, 33166, United States
Precision Research Org, LLC /ID# 153276
Miami Lakes, Florida, 33016-1501, United States
Suncoast Clinical Research /ID# 153206
New Port Richey, Florida, 34652, United States
Advanced Research Institute /ID# 153413
New Port Richey, Florida, 34653, United States
Clinical Associates of Orlando /ID# 153427
Orlando, Florida, 32806, United States
Unified Womens Clin Research /ID# 153229
Panama City, Florida, 32045, United States
All Wmns HC of West Broward /ID# 153434
Plantation, Florida, 33324, United States
Oncova Clinical Research, Inc. /ID# 153497
Saint Cloud, Florida, 34769, United States
Physician Care Clin. Res., LLC /ID# 153210
Sarasota, Florida, 34239, United States
Qps-Mra, Llc /Id# 153456
South Miami, Florida, 33143, United States
University of South Florida /ID# 153271
Tampa, Florida, 33612, United States
Axcess Medical Research /ID# 153500
Wellington, Florida, 33414, United States
Virtus Research Consultant,LLC /ID# 153398
Wellington, Florida, 33414, United States
Comprehensive Clinical Trials /ID# 153350
West Palm Beach, Florida, 33409, United States
Atlanta Medical Research Insti /ID# 153298
Alpharetta, Georgia, 30005-4419, United States
Paramount Research Solutions /ID# 153424
Alpharetta, Georgia, 30005, United States
Paramount Research Solutions /ID# 160974
Alpharetta, Georgia, 30005, United States
Mount Vernon Clinical Res, LLC /ID# 153403
Atlanta, Georgia, 30328, United States
Atlanta Women's Research Inst /ID# 153212
Atlanta, Georgia, 30342, United States
Masters of Clinical Research, Inc. /ID# 153295
Augusta, Georgia, 30909, United States
Paramount Research Solutions /ID# 153351
College Park, Georgia, 30349, United States
Fellows Research Alliance, Inc /ID# 153227
Savannah, Georgia, 31406, United States
Clinical Research Consultants of Atlanta /ID# 153285
Suwanee, Georgia, 30024-6988, United States
Atlanta Gynecology Research Institute /ID# 200074
Suwanee, Georgia, 30024-7159, United States
Sonora Clinical Research /ID# 153231
Meridian, Idaho, 83646-1144, United States
Affinity Clinical Research /ID# 153417
Oak Brook, Illinois, 60523, United States
Bluegrass Clinical Research /ID# 153280
Louisville, Kentucky, 40291, United States
Clinical Trials Management, LLC - Covington /ID# 153211
Covington, Louisiana, 70433, United States
Clinical Trials Management, LLC - Covington /ID# 153439
Covington, Louisiana, 70433, United States
Ochsner Baptist Medical Center /ID# 153459
New Orleans, Louisiana, 70115, United States
Omni Fertility and Laser Insti /ID# 153228
Shreveport, Louisiana, 71118, United States
Baltimore Suburban Health /ID# 168386
Baltimore, Maryland, 21208, United States
NECCR Fall River LLC /ID# 153274
Fall River, Massachusetts, 02720-2972, United States
Genesis Clinical Research /ID# 153379
Fall River, Massachusetts, 02720, United States
Great Lakes Research Group,Inc /ID# 153302
Bay City, Michigan, 48706, United States
Saginaw Valley Med Res Group /ID# 153498
Saginaw, Michigan, 48604, United States
Wayne State University Physician Group - Southfield /ID# 153418
Southfield, Michigan, 48034, United States
Accent Clinical Trials /ID# 153474
Las Vegas, Nevada, 89106-4017, United States
Office of Edmond E. Pack, MD /ID# 153411
Las Vegas, Nevada, 89113, United States
Mabey, Las Vegas, NV /ID# 153314
Las Vegas, Nevada, 89128, United States
Lawrence OB/GYN /ID# 153218
Lawrenceville, New Jersey, 08648, United States
Jersey Shore University Medical Center /ID# 153495
Neptune City, New Jersey, 07753-4859, United States
Bosque Women's Care /ID# 153223
Albuquerque, New Mexico, 87109, United States
SUNY Downstate Medical Center /ID# 153344
Brooklyn, New York, 11203, United States
Manhattan Medical Research /ID# 153386
New York, New York, 10016-6023, United States
Weill Cornell Medicine /ID# 153275
New York, New York, 10032-3725, United States
Cwrwc /Id# 153313
Durham, North Carolina, 27713, United States
Unified Women's Clinical Research-Greensboro /ID# 153499
Greensboro, North Carolina, 27408, United States
Pinewest Ob-Gyn, Inc. /ID# 153197
High Point, North Carolina, 27262, United States
Eastern Carolina Women's Centr /ID# 153341
New Bern, North Carolina, 28562, United States
Unified Women's Clinical Resea /ID# 153312
Raleigh, North Carolina, 27607, United States
Wake Research Associates, LLC /ID# 153402
Raleigh, North Carolina, 27612, United States
Unified Women's Clinical Resea /ID# 153297
Winston-Salem, North Carolina, 27103, United States
Clinical Inquest Center Ltd /ID# 153436
Beavercreek, Ohio, 45432, United States
CTI Clinical Research Center /ID# 153201
Cincinnati, Ohio, 45212, United States
University Hospitals Cleveland /ID# 153450
Cleveland, Ohio, 44106, United States
University of Toledo /ID# 153409
Toledo, Ohio, 43614, United States
Comprehensive Womens Care /ID# 153396
Westerville, Ohio, 43081, United States
Legacy Medical Group-Portland /ID# 168286
Portland, Oregon, 97210, United States
Main Line Fertility Center /ID# 153410
Bryn Mawr, Pennsylvania, 19010, United States
Penn State University and Milton S. Hershey Medical Center /ID# 153443
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania /ID# 153203
Philadelphia, Pennsylvania, 19104-5502, United States
Thomas Jefferson University /ID# 153319
Philadelphia, Pennsylvania, 19107-4414, United States
Clinical Research of Philadelphia, LLC /ID# 153279
Philadelphia, Pennsylvania, 19114, United States
Reading Hosp Clncl Trials Ofc /ID# 153475
West Reading, Pennsylvania, 19611, United States
Medical University of South Carolina /ID# 153325
Charleston, South Carolina, 29425, United States
Vista Clinical Research /ID# 153399
Columbia, South Carolina, 29201, United States
Chattanooga Medical Research /ID# 153405
Chattanooga, Tennessee, 37404, United States
WR-ClinSearch /ID# 153404
Chattanooga, Tennessee, 37421-1605, United States
Research Memphis Associates, LLC /ID# 153322
Memphis, Tennessee, 38119-3895, United States
Women's Health Trials /ID# 153426
Menphis, Tennessee, 38104, United States
Access Clinical Trials, Inc. /ID# 153441
Nashville, Tennessee, 37203, United States
Lotus Gynecology /ID# 153476
Austin, Texas, 78703-1448, United States
Texas Health Presbyterian Hosp /ID# 153339
Dallas, Texas, 75231, United States
UT Southwestern Medical Center /ID# 153400
Dallas, Texas, 75390-7208, United States
Baylor Scott & White /ID# 153273
Fort Worth, Texas, 76104-4110, United States
Willowbend Health and Wellness /ID# 153458
Frisco, Texas, 75035, United States
Advances in Health, Inc. /ID# 153414
Houston, Texas, 77030, United States
The Woman's Hospital of Texas /ID# 153270
Houston, Texas, 77054, United States
FMC Science /ID# 153289
Lampasas, Texas, 76550, United States
Clinical Trials of Texas,Inc. /ID# 153209
San Antonio, Texas, 78229, United States
Discovery Clinical Trials-San Antonio /ID# 153315
San Antonio, Texas, 78258, United States
Houston Ctr for Clin Research /ID# 153221
Sugar Land, Texas, 77479, United States
Center of Reproductive Medicin /ID# 153320
Webster, Texas, 77598, United States
Tidewater Physicians for Women /ID# 153432
Norfolk, Virginia, 23502, United States
Eastern Virginia Med School /ID# 153380
Norfolk, Virginia, 23507-1627, United States
Clinical Research Partners, LL /ID# 153412
North Chesterfield, Virginia, 23235-4722, United States
Clinical Research Partners, LLC /ID# 153343
Richmond, Virginia, 23220-4459, United States
Clinical Trials Virginia, Inc. /ID# 153419
Richmond, Virginia, 23225, United States
Emerson Clinical Research Inst /ID# 153416
Vienna, Virginia, 22182, United States
Virginia Mason Medical Center /ID# 153342
Seattle, Washington, 98101, United States
Seattle Women's Health, Research, Gynecology /ID# 153306
Seattle, Washington, 98105, United States
Victory Reproductive Care /ID# 153299
Windsor, Ontario, N8W 5R7, Canada
Rodriguez-Ginorio, San Juan /ID# 153328
San Juan, 00917, Puerto Rico
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329
San Juan, 00935, Puerto Rico
Related Publications (2)
Simon JA, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Dayspring T, Feinberg EC, Gillispie V, Hurtado S, Kim J, Liu R, Owens CD, Muneyyirci-Delale O, Wang A, Watts NB, Schlaff WD. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstet Gynecol. 2020 Jun;135(6):1313-1326. doi: 10.1097/AOG.0000000000003869.
PMID: 32459423BACKGROUNDBeck 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: 34878624DERIVED
MeSH Terms
Conditions
Interventions
Condition 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
September 24, 2016
First Posted
October 6, 2016
Study Start
September 14, 2016
Primary Completion
May 7, 2018
Study Completion
March 22, 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.