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
- Conditions
- Uterine FibroidsHeavy Menstrual Bleeding
- Interventions
- Drug: Placebo for Estradiol/Norethindrone Acetate
- Registration Number
- NCT02654054
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 413
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elagolix Elagolix Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD Placebo Placebo for Estradiol/Norethindrone Acetate Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/NETA) once daily (QD) Elagolix Placebo for Estradiol/Norethindrone Acetate Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD Elagolix + E2/NETA Estradiol/Norethindrone Acetate Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD Placebo Placebo for Elagolix Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/NETA) once daily (QD) Elagolix + E2/NETA Elagolix Elagolix 300 mg BID and 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 Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in MBL Volume to the Final Month Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, 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.
The Reference Day 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.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 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.
The Reference Day 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.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 Change From Baseline in MBL Volume to Month 1 Month 0 (Baseline), Month 1
Related Research Topics
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Trial Locations
- Locations (96)
Houston Ctr for Clin Research /ID# 149149
🇺🇸Sugar Land, Texas, United States
Fellows Research Alliance, Inc /ID# 139655
🇺🇸Savannah, Georgia, United States
University of California, Los Angeles /ID# 144107
🇺🇸Los Angeles, California, United States
Agile Clinical Research Trials /ID# 143563
🇺🇸Atlanta, Georgia, United States
Perimeter Inst Clinical Resear /ID# 148298
🇺🇸Atlanta, Georgia, United States
Great Lakes Clinical Trials /ID# 148135
🇺🇸Chicago, Illinois, United States
Rodriguez-Ginorio, San Juan /ID# 139847
🇵🇷San Juan, Puerto Rico
Advances in Health, Inc. /ID# 139672
🇺🇸Houston, Texas, United States
Seattle Women's Health, Research, Gynecology /ID# 139768
🇺🇸Seattle, Washington, United States
LCC Medical Research Institute /ID# 143551
🇺🇸Miami, Florida, United States
Healthcare Clinical Data, Inc /ID# 139650
🇺🇸Miami, Florida, United States
Ocean Blue Med Research Ctr /ID# 139826
🇺🇸Miami, Florida, United States
Office of Edmond E. Pack, MD /ID# 139792
🇺🇸Las Vegas, Nevada, United States
Cwrwc /Id# 139664
🇺🇸Durham, North Carolina, United States
Access Clinical Trials, Inc. /ID# 139730
🇺🇸Nashville, Tennessee, United States
Victorium Clinical Research /ID# 149630
🇺🇸San Antonio, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 139776
🇺🇸San Antonio, Texas, United States
Summers, Birmingham, AL /ID# 139684
🇺🇸Birmingham, Alabama, United States
Long Beach Clinical Trial Serv /ID# 152424
🇺🇸Long Beach, California, United States
Unified Womens Clin Research /ID# 145169
🇺🇸Panama City, Florida, United States
Cypress Medical Research Ctr /ID# 147116
🇺🇸Wichita, Kansas, United States
American Health Network of IN /ID# 139822
🇺🇸Avon, Indiana, United States
Temple University Hospital /ID# 151429
🇺🇸Philadelphia, Pennsylvania, United States
Center of Reproductive Medicin /ID# 139813
🇺🇸Webster, Texas, United States
IWK Health Center /ID# 149066
🇨🇦Halifax, Nova Scotia, Canada
GTC Research /ID# 141854
🇺🇸Kansas City, Kansas, United States
Legacy Medical Group-Portland /ID# 148807
🇺🇸Portland, Oregon, United States
Froedtert and Medical College /ID# 143566
🇺🇸Milwaukee, Wisconsin, United States
PMG Research of Wilmington LLC /ID# 152563
🇺🇸Wilmington, North Carolina, United States
Unified Women's Clinical Research-Greensboro /ID# 139829
🇺🇸Greensboro, North Carolina, United States
WCCT Global, LLC /ID# 145666
🇺🇸Costa Mesa, California, United States
University of South Alabama /ID# 148763
🇺🇸Mobile, Alabama, United States
American Clinical Trials /ID# 147374
🇺🇸Hawaiian Gardens, California, United States
Grossmont Ctr Clin Research /ID# 144011
🇺🇸La Mesa, California, United States
National Research Institute /ID# 151629
🇺🇸Los Angeles, California, United States
Beach OBGYN Medical Group /ID# 151414
🇺🇸Newport Beach, California, United States
Bluebird Clinical Trials, LLC /ID# 144843
🇺🇸Colorado Springs, Colorado, United States
Advanced RX Clinical Research /ID# 149168
🇺🇸Westminster, California, United States
Medstar Health Research Institute /ID# 145933
🇺🇸Washington, District of Columbia, United States
Advanced Women's Health Institution /ID# 144108
🇺🇸Greenwood Village, Colorado, United States
James A. Simon, MD, PC /ID# 139675
🇺🇸Washington, District of Columbia, United States
Helix Biomedics, LLC /ID# 147114
🇺🇸Boynton Beach, Florida, United States
Universal Clinical Research A /ID# 139742
🇺🇸Doral, Florida, United States
Brandon Premier Health Care, PA /ID# 153130
🇺🇸Brandon, Florida, United States
Florida Clin Res Group /ID# 139811
🇺🇸Ckearwater, Florida, United States
Clinical Physiology Associates /ID# 139736
🇺🇸Fort Myers, Florida, United States
Meridien Research /ID# 139663
🇺🇸Kenneth City, Florida, United States
Altus Research, Inc /ID# 139662
🇺🇸Lake Worth, Florida, United States
South Florida Wellness & Clinic /ID# 143558
🇺🇸Margate, Florida, United States
Advanced Research Institute /ID# 143554
🇺🇸New Port Richey, Florida, United States
Salom Tangir, LLC /ID# 151732
🇺🇸Miramar, Florida, United States
Paramount Research Solutions /ID# 139645
🇺🇸Alpharetta, Georgia, United States
Comprehensive Clinical Trials /ID# 139644
🇺🇸West Palm Beach, Florida, United States
Masters of Clinical Research, Inc. /ID# 139658
🇺🇸Augusta, Georgia, United States
Women's Health Practice, LLC /ID# 143569
🇺🇸Champaign, Illinois, United States
Affinity Clinical Research /ID# 150980
🇺🇸Oak Brook, Illinois, United States
Boise Family Medical Center /ID# 139844
🇺🇸Boise, Idaho, United States
Research Integrity, LLC /ID# 139727
🇺🇸Owensboro, Kentucky, United States
Omni Fertility and Laser Insti /ID# 139836
🇺🇸Shreveport, Louisiana, United States
Clinical Trials Management, LLC - Covington /ID# 139651
🇺🇸Covington, Louisiana, United States
Capital Women's Care /ID# 144109
🇺🇸Frederick, Maryland, United States
Great Lakes Research Group,Inc /ID# 139659
🇺🇸Bay City, Michigan, United States
Genesis Clinical Research - Fall River /ID# 148449
🇺🇸Fall River, Massachusetts, United States
Wayne State University Physician Group - Southfield /ID# 139802
🇺🇸Southfield, Michigan, United States
Grand Rapids Womens Health /ID# 139705
🇺🇸Grand Rapids, Michigan, United States
Lawrence OB/GYN /ID# 143567
🇺🇸Lawrenceville, New Jersey, United States
Mabey, Las Vegas, NV /ID# 148138
🇺🇸Las Vegas, Nevada, United States
Bosque Women's Care /ID# 145934
🇺🇸Albuquerque, New Mexico, United States
Manhattan Medical Research /ID# 144471
🇺🇸New York, New York, United States
Unified Women's Clinical Resea /ID# 139774
🇺🇸Raleigh, North Carolina, United States
University of Cincinnati /ID# 139820
🇺🇸Cincinnati, Ohio, United States
Univ Hosp Cleveland /ID# 139741
🇺🇸Cleveland, Ohio, United States
Miami Valley Hospital /ID# 144430
🇺🇸Dayton, Ohio, United States
Complete Healthcare for Women /ID# 139673
🇺🇸Columbus, Ohio, United States
University of Toledo /ID# 139787
🇺🇸Toledo, Ohio, United States
Thomas Jefferson University /ID# 139812
🇺🇸Philadelphia, Pennsylvania, United States
Main Line Fertility Center /ID# 150295
🇺🇸Bryn Mawr, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 139733
🇺🇸Hershey, Pennsylvania, United States
Vista Clinical Research /ID# 139797
🇺🇸Columbia, South Carolina, United States
WR-ClinSearch /ID# 143538
🇺🇸Chattanooga, Tennessee, United States
Research Memphis Associates, LLC /ID# 139674
🇺🇸Memphis, Tennessee, United States
Clinical Trials Research Svcs /ID# 139707
🇺🇸Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center /ID# 143537
🇺🇸Dallas, Texas, United States
Eastern Virginia Med School /ID# 139647
🇺🇸Norfolk, Virginia, United States
Clinical Research Partners, LL /ID# 143999
🇺🇸North Chesterfield, Virginia, United States
Emerson Clinical Research /ID# 147373
🇺🇸Vienna, Virginia, United States
Premier Clinical Research /ID# 148145
🇺🇸Spokane, Washington, United States
The Ottawa Hospital /ID# 148695
🇨🇦Ottawa, Ontario, Canada
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848
🇵🇷San Juan, Puerto Rico
Clinical Associates of Orlando /ID# 148123
🇺🇸Orlando, Florida, United States
Omega Research Consultants /ID# 139648
🇺🇸Orlando, Florida, United States
Ochsner Baptist Medical Center /ID# 139740
🇺🇸New Orleans, Louisiana, United States
Unified Women's Clinical Resea /ID# 144721
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina /ID# 148754
🇺🇸Charleston, South Carolina, United States
Clinical Trials Virginia, Inc. /ID# 139801
🇺🇸Richmond, Virginia, United States
Atlanta Medical Research Insti /ID# 147117
🇺🇸Alpharetta, Georgia, United States