An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- Conditions
- Uterine FibroidsHeavy Menstrual Bleeding
- Interventions
- Registration Number
- NCT02925494
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 433
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA) Estradiol/Norethindrone Acetate Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA) Elagolix Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) Elagolix Elagolix Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
- Primary Outcome Measures
Name Time Method Percentage of Participants Meeting the Criteria for Responder From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Suppression of Bleeding at the Final Month Final Month of Treatment Period (up through Month 6) Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.
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) Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
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 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) Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Trial Locations
- Locations (124)
Choice Research, LLC /ID# 153492
🇺🇸Dothan, Alabama, United States
NECCR Fall River LLC /ID# 153274
🇺🇸Fall River, Massachusetts, United States
Mount Vernon Clinical Res, LLC /ID# 153403
🇺🇸Atlanta, Georgia, United States
Clinical Research of Philadelphia, LLC /ID# 153279
🇺🇸Philadelphia, Pennsylvania, United States
University Hospitals Cleveland /ID# 153450
🇺🇸Cleveland, Ohio, United States
Virginia Mason Medical Center /ID# 153342
🇺🇸Seattle, Washington, United States
Seattle Women's Health, Research, Gynecology /ID# 153306
🇺🇸Seattle, Washington, United States
Invictus Clinical Research Group,LLC /ID# 153196
🇺🇸Miami, Florida, United States
Accent Clinical Trials /ID# 153474
🇺🇸Las Vegas, Nevada, United States
Office of Edmond E. Pack, MD /ID# 153411
🇺🇸Las Vegas, Nevada, United States
Mabey, Las Vegas, NV /ID# 153314
🇺🇸Las Vegas, Nevada, United States
Futura Research, Inc. /ID# 153345
🇺🇸Norwalk, California, United States
Mobile, Ob-Gyn, P.C. /ID# 153442
🇺🇸Mobile, Alabama, United States
Medstar Health Research Institute /ID# 153321
🇺🇸Washington, District of Columbia, United States
Farid Yasharpour MD Medical Co /ID# 153482
🇺🇸San Fernando, California, United States
Mesa Obstetricians and Gynecol /ID# 153269
🇺🇸Mesa, Arizona, United States
Solutions Through Adv Rch /ID# 153283
🇺🇸Jacksonville, Florida, United States
Brandon Premier Health Care, PA /ID# 165791
🇺🇸Brandon, Florida, United States
LCC Medical Research Institute /ID# 153296
🇺🇸Miami, Florida, United States
Core Healthcare Group /ID# 153282
🇺🇸Cerritos, California, United States
Diagnamics Inc. /ID# 153347
🇺🇸Encinitas, California, United States
Sonora Clinical Research /ID# 153231
🇺🇸Meridian, Idaho, United States
Clinical Physiology Assoc. /ID# 153444
🇺🇸Fort Myers, Florida, United States
Omega Research Consultants, LLC /ID# 153381
🇺🇸DeBary, Florida, United States
Atlanta Medical Research Insti /ID# 153298
🇺🇸Alpharetta, Georgia, United States
Masters of Clinical Research, Inc. /ID# 153295
🇺🇸Augusta, Georgia, United States
Axcess Medical Research /ID# 153500
🇺🇸Wellington, Florida, United States
UT Southwestern Medical Center /ID# 153400
🇺🇸Dallas, Texas, United States
The Woman's Hospital of Texas /ID# 153270
🇺🇸Houston, Texas, United States
Center of Reproductive Medicin /ID# 153320
🇺🇸Webster, Texas, United States
Baylor Scott & White /ID# 153273
🇺🇸Fort Worth, Texas, United States
Advances in Health, Inc. /ID# 153414
🇺🇸Houston, Texas, United States
Houston Ctr for Clin Research /ID# 153221
🇺🇸Sugar Land, Texas, United States
FMC Science /ID# 153289
🇺🇸Lampasas, Texas, United States
Rodriguez-Ginorio, San Juan /ID# 153328
🇵🇷San Juan, Puerto Rico
Eastern Virginia Med School /ID# 153380
🇺🇸Norfolk, Virginia, United States
University of Toledo /ID# 153409
🇺🇸Toledo, Ohio, United States
Penn State University and Milton S. Hershey Medical Center /ID# 153443
🇺🇸Hershey, Pennsylvania, United States
Willowbend Health and Wellness /ID# 153458
🇺🇸Frisco, Texas, United States
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329
🇵🇷San Juan, Puerto Rico
Tidewater Physicians for Women /ID# 153432
🇺🇸Norfolk, Virginia, United States
Cwrwc /Id# 153313
🇺🇸Durham, North Carolina, United States
Clinical Trials of Texas,Inc. /ID# 153209
🇺🇸San Antonio, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 153315
🇺🇸San Antonio, Texas, United States
Alabama Clinical Therapeutics, LLC /ID# 153336
🇺🇸Birmingham, Alabama, United States
University of South Florida /ID# 153271
🇺🇸Tampa, Florida, United States
Atlanta Women's Research Inst /ID# 153212
🇺🇸Atlanta, Georgia, United States
Emerson Clinical Research Inst /ID# 153416
🇺🇸Vienna, Virginia, United States
Alabama Clinical Therapeutics, LLC /ID# 153217
🇺🇸Birmingham, Alabama, United States
University of South Alabama /ID# 153415
🇺🇸Mobile, Alabama, United States
Brown, Pearson, Guepet Gynecology /ID# 153278
🇺🇸Fairhope, Alabama, United States
Grossmont Ctr Clin Research /ID# 153324
🇺🇸La Mesa, California, United States
Emerson Clinical Research Inst /ID# 162755
🇺🇸Washington, District of Columbia, United States
Florida Fertility Institute /ID# 153308
🇺🇸Clearwater, Florida, United States
KO Clinical Research, LLC /ID# 153198
🇺🇸Fort Lauderdale, Florida, United States
Altus Research, Inc /ID# 153307
🇺🇸Lake Worth, Florida, United States
Healthcare Clinical Data, Inc /ID# 153425
🇺🇸Miami, Florida, United States
Oncova Clinical Research, Inc. /ID# 153497
🇺🇸Saint Cloud, Florida, United States
Qps-Mra, Llc /Id# 153456
🇺🇸South Miami, Florida, United States
Comprehensive Clinical Trials /ID# 153350
🇺🇸West Palm Beach, Florida, United States
Paramount Research Solutions /ID# 153424
🇺🇸Alpharetta, Georgia, United States
Clinical Research Consultants of Atlanta /ID# 153285
🇺🇸Suwanee, Georgia, United States
Paramount Research Solutions /ID# 153351
🇺🇸College Park, Georgia, United States
Fellows Research Alliance, Inc /ID# 153227
🇺🇸Savannah, Georgia, United States
Affinity Clinical Research /ID# 153417
🇺🇸Oak Brook, Illinois, United States
Clinical Trials Management, LLC - Covington /ID# 153211
🇺🇸Covington, Louisiana, United States
Baltimore Suburban Health /ID# 168386
🇺🇸Baltimore, Maryland, United States
Genesis Clinical Research /ID# 153379
🇺🇸Fall River, Massachusetts, United States
Wayne State University Physician Group - Southfield /ID# 153418
🇺🇸Southfield, Michigan, United States
Lawrence OB/GYN /ID# 153218
🇺🇸Lawrenceville, New Jersey, United States
Jersey Shore University Medical Center /ID# 153495
🇺🇸Neptune, New Jersey, United States
Bosque Women's Care /ID# 153223
🇺🇸Albuquerque, New Mexico, United States
Manhattan Medical Research /ID# 153386
🇺🇸New York, New York, United States
SUNY Downstate Medical Center /ID# 153344
🇺🇸Brooklyn, New York, United States
Weill Cornell Medicine /ID# 153275
🇺🇸New York, New York, United States
Unified Women's Clinical Research-Greensboro /ID# 153499
🇺🇸Greensboro, North Carolina, United States
Eastern Carolina Women's Centr /ID# 153341
🇺🇸New Bern, North Carolina, United States
Wake Research Associates, LLC /ID# 153402
🇺🇸Raleigh, North Carolina, United States
Pinewest Ob-Gyn, Inc. /ID# 153197
🇺🇸High Point, North Carolina, United States
CTI Clinical Research Center /ID# 153201
🇺🇸Cincinnati, Ohio, United States
Clinical Inquest Center Ltd /ID# 153436
🇺🇸Beavercreek, Ohio, United States
Legacy Medical Group-Portland /ID# 168286
🇺🇸Portland, Oregon, United States
Comprehensive Womens Care /ID# 153396
🇺🇸Westerville, Ohio, United States
Main Line Fertility Center /ID# 153410
🇺🇸Bryn Mawr, Pennsylvania, United States
University of Pennsylvania /ID# 153203
🇺🇸Philadelphia, Pennsylvania, United States
Reading Hosp Clncl Trials Ofc /ID# 153475
🇺🇸West Reading, Pennsylvania, United States
Chattanooga Medical Research /ID# 153405
🇺🇸Chattanooga, Tennessee, United States
WR-ClinSearch /ID# 153404
🇺🇸Chattanooga, Tennessee, United States
Research Memphis Associates, LLC /ID# 153322
🇺🇸Memphis, Tennessee, United States
Women's Health Trials /ID# 153426
🇺🇸Menphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 153441
🇺🇸Nashville, Tennessee, United States
Texas Health Presbyterian Hosp /ID# 153339
🇺🇸Dallas, Texas, United States
Clinical Research Partners, LL /ID# 153412
🇺🇸North Chesterfield, Virginia, United States
James A. Simon, MD, PC /ID# 153323
🇺🇸Washington, District of Columbia, United States
Thomas Jefferson University /ID# 153319
🇺🇸Philadelphia, Pennsylvania, United States
Advanced Women's Health Institution /ID# 153401
🇺🇸Greenwood Village, Colorado, United States
Omni Fertility and Laser Insti /ID# 153228
🇺🇸Shreveport, Louisiana, United States
South Florida Wellness & Clinic /ID# 153420
🇺🇸Margate, Florida, United States
Precision Research Org, LLC /ID# 153276
🇺🇸Miami Lakes, Florida, United States
Meridien Research /ID# 153310
🇺🇸Kenneth City, Florida, United States
All Wmns HC of West Broward /ID# 153434
🇺🇸Plantation, Florida, United States
Ocean Blue Med Research Ctr /ID# 153225
🇺🇸Miami, Florida, United States
Helix Biomedics, LLC /ID# 153440
🇺🇸Boynton Beach, Florida, United States
Virtus Research Consultant,LLC /ID# 153398
🇺🇸Wellington, Florida, United States
Suncoast Clinical Research /ID# 153206
🇺🇸New Port Richey, Florida, United States
Physician Care Clin. Res., LLC /ID# 153210
🇺🇸Sarasota, Florida, United States
Advanced Research Institute /ID# 153413
🇺🇸New Port Richey, Florida, United States
Paramount Research Solutions /ID# 160974
🇺🇸Alpharetta, Georgia, United States
Clinical Trials Management, LLC - Covington /ID# 153439
🇺🇸Covington, Louisiana, United States
Saginaw Valley Med Res Group /ID# 153498
🇺🇸Saginaw, Michigan, United States
Unified Women's Clinical Resea /ID# 153312
🇺🇸Raleigh, North Carolina, United States
Victory Reproductive Care /ID# 153299
🇨🇦Windsor, Ontario, Canada
Vista Clinical Research /ID# 153399
🇺🇸Columbia, South Carolina, United States
Clinical Associates of Orlando /ID# 153427
🇺🇸Orlando, Florida, United States
Bluegrass Clinical Research /ID# 153280
🇺🇸Louisville, Kentucky, United States
Ochsner Baptist Medical Center /ID# 153459
🇺🇸New Orleans, Louisiana, United States
Unified Women's Clinical Resea /ID# 153297
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina /ID# 153325
🇺🇸Charleston, South Carolina, United States
Lotus Gynecology /ID# 153476
🇺🇸Austin, Texas, United States
Clinical Research Partners, LLC /ID# 153343
🇺🇸Richmond, Virginia, United States
Clinical Trials Virginia, Inc. /ID# 153419
🇺🇸Richmond, Virginia, United States
Unified Womens Clin Research /ID# 153229
🇺🇸Panama City, Florida, United States
Atlanta Gynecology Research Institute /ID# 200074
🇺🇸Suwanee, Georgia, United States
Great Lakes Research Group,Inc /ID# 153302
🇺🇸Bay City, Michigan, United States