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)
- Conditions
- Heavy Menstrual BleedingUterine Fibroids
- Interventions
- Drug: Placebo for Estradiol/Norethindrone Acetate
- Registration Number
- NCT02691494
- 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
- 378
- 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 Placebo Placebo for Elagolix Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (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 Elagolix Elagolix Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) 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 Month 3 Month 0 (Baseline), Month 3 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.
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 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.
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 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 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.
Trial Locations
- Locations (105)
University of California, Los Angeles /ID# 149760
🇺🇸Los Angeles, California, United States
Mount Vernon Clinical Res, LLC /ID# 144297
🇺🇸Atlanta, Georgia, United States
Clinical Trial Investigators /ID# 152470
🇺🇸Tustin, California, United States
Ideal Clinical Research Inc. /ID# 149757
🇺🇸Aventura, Florida, United States
Unified Women's Clinical Research-Greensboro /ID# 149588
🇺🇸Greensboro, North Carolina, United States
Baltimore Suburban Health /ID# 154638
🇺🇸Baltimore, Maryland, United States
Invictus Clinical Research Group,LLC /ID# 141859
🇺🇸Miami, Florida, United States
The Woman's Hospital of Texas /ID# 144319
🇺🇸Houston, Texas, United States
BI Research Center /ID# 149143
🇺🇸Houston, Texas, United States
Accent Clinical Trials /ID# 149753
🇺🇸Las Vegas, Nevada, United States
The Christ Hospital /ID# 150104
🇺🇸Cincinnati, Ohio, United States
HCP Clinical Research LLC /ID# 154434
🇺🇸Huntington Beach, California, United States
KO Clinical Research, LLC /ID# 144299
🇺🇸Fort Lauderdale, Florida, United States
Precision Research Org, LLC /ID# 144335
🇺🇸Miami Lakes, Florida, United States
Mobile, Ob-Gyn, P.C. /ID# 144294
🇺🇸Mobile, Alabama, United States
Atlanta Women's Research Inst /ID# 144303
🇺🇸Atlanta, Georgia, United States
Willowbend Health and Wellness /ID# 144318
🇺🇸Plano, Texas, United States
Wake Research Associates, LLC /ID# 144307
🇺🇸Raleigh, North Carolina, United States
Centex Studies, Inc. - Houston /ID# 150106
🇺🇸Houston, Texas, United States
Center of Reproductive Medicin /ID# 167235
🇺🇸Webster, Texas, United States
Access Clinical Trials, Inc. /ID# 167333
🇺🇸Nashville, Tennessee, United States
Alabama Clinical Therapeutics, LLC /ID# 152258
🇺🇸Birmingham, Alabama, United States
Choice Research, LLC /ID# 150988
🇺🇸Dothan, Alabama, United States
Brown, Pearson, Guepet Gynecology /ID# 151020
🇺🇸Fairhope, Alabama, United States
Visions Clinical Research-Tucs /ID# 151017
🇺🇸Tucson, Arizona, United States
Mesa Obstetricians and Gynecol /ID# 149139
🇺🇸Mesa, Arizona, United States
Diagnamics Inc. /ID# 152469
🇺🇸Encinitas, California, United States
Core Healthcare Group /ID# 151016
🇺🇸Cerritos, California, United States
Alliance Research Centers /ID# 149752
🇺🇸Laguna Hills, California, United States
Farid Yasharpour MD Medical Co /ID# 149770
🇺🇸San Fernando, California, United States
Bayview Research Group LLC /ID# 153799
🇺🇸Valley Village, California, United States
Futura Research, Inc. /ID# 149759
🇺🇸Norwalk, California, United States
Seffner Premier Health Care, P /ID# 167480
🇺🇸Brandon, Florida, United States
Emerson Clinical Research Inst /ID# 152348
🇺🇸Washington, District of Columbia, United States
Olympian Clinical Research /ID# 149756
🇺🇸Clearwater, Florida, United States
Solutions Through Adv Rch /ID# 151021
🇺🇸Jacksonville, Florida, United States
All Wmns HC of West Broward /ID# 144298
🇺🇸Plantation, Florida, United States
Meridien Research /ID# 167100
🇺🇸Kenneth City, Florida, United States
Physician Care Clin. Res., LLC /ID# 149766
🇺🇸Sarasota, Florida, United States
Paramount Research Solutions /ID# 149291
🇺🇸Alpharetta, Georgia, United States
Suncoast Clinical Research /ID# 149765
🇺🇸New Port Richey, Florida, United States
Martin Health System Center /ID# 152263
🇺🇸Stuart, Florida, United States
Oncova Clinical Research, Inc. /ID# 149764
🇺🇸Saint Cloud, Florida, United States
Qps-Mra, Llc /Id# 144325
🇺🇸South Miami, Florida, United States
Gyn-Care, Inc. /ID# 149341
🇺🇸Smyrna, Georgia, United States
Agile Clinical Research Trials /ID# 167074
🇺🇸Atlanta, Georgia, United States
Meridian Clinical Research, LLC /ID# 149144
🇺🇸Savannah, Georgia, United States
Axcess Medical Research /ID# 149769
🇺🇸Wellington, Florida, United States
Atlanta Gynecology Research Institute /ID# 151014
🇺🇸Suwanee, Georgia, United States
Virtus Research Consultant,LLC /ID# 144296
🇺🇸Wellington, Florida, United States
Masters of Clinical Research, Inc. /ID# 167400
🇺🇸Augusta, Georgia, United States
Georgia Regents University /ID# 144295
🇺🇸Augusta, Georgia, United States
Womens Healthcare Assoc, DBA /ID# 149762
🇺🇸Idaho Falls, Idaho, United States
University of Chicago /ID# 152257
🇺🇸Chicago, Illinois, United States
Advanced Clinical Research /ID# 149767
🇺🇸Meridian, Idaho, United States
Affinity Clinical Research /ID# 167119
🇺🇸Oak Brook, Illinois, United States
Center for Women's Research, Inc /ID# 144300
🇺🇸Palos Heights, Illinois, United States
The Iowa Clinic /ID# 150105
🇺🇸West Des Moines, Iowa, United States
Women's Health Advantage /ID# 144301
🇺🇸Fort Wayne, Indiana, United States
Clinical Trials Management, LLC - Covington /ID# 144314
🇺🇸Covington, Louisiana, United States
PRN Professional Research Network of Kansas, LLC /ID# 152265
🇺🇸Wichita, Kansas, United States
NECCR Fall River LLC /ID# 149584
🇺🇸Fall River, Massachusetts, United States
Womens Health Center /ID# 154209
🇺🇸Glen Burnie, Maryland, United States
Maryland Ctr for Sexual Health /ID# 149778
🇺🇸Lutherville, Maryland, United States
Saginaw Valley Med Res Group /ID# 149768
🇺🇸Saginaw, Michigan, United States
Jersey Shore University Medical Center /ID# 149779
🇺🇸Neptune, New Jersey, United States
SUNY Downstate Medical Center /ID# 144311
🇺🇸Brooklyn, New York, United States
Manhattan Medical Research /ID# 167077
🇺🇸New York, New York, United States
Weill Cornell Medicine /ID# 149585
🇺🇸New York, New York, United States
Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587
🇺🇸Fayetteville, North Carolina, United States
Eastern Carolina Women's Centr /ID# 144309
🇺🇸New Bern, North Carolina, United States
Clinical Inquest Center Ltd /ID# 148728
🇺🇸Beavercreek, Ohio, United States
CTI Clinical Research Center /ID# 149761
🇺🇸Cincinnati, Ohio, United States
Alpha Research Associates LLC /ID# 152471
🇺🇸Dayton, Ohio, United States
Comprehensive Womens Care /ID# 144306
🇺🇸Westerville, Ohio, United States
Family Medical Associates /ID# 145668
🇺🇸Levittown, Pennsylvania, United States
University of Pennsylvania /ID# 149586
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia, LLC /ID# 151015
🇺🇸Philadelphia, Pennsylvania, United States
Chattanooga Women for Women /ID# 167051
🇺🇸Hixson, Tennessee, United States
Holston Medical Group /ID# 149763
🇺🇸Bristol, Tennessee, United States
The Womens Physician Group /ID# 144317
🇺🇸Memphis, Tennessee, United States
Reading Hosp Clncl Trials Ofc /ID# 149583
🇺🇸West Reading, Pennsylvania, United States
The Jackson Clinic, PA /ID# 145670
🇺🇸Jackson, Tennessee, United States
Chattanooga Medical Research /ID# 145667
🇺🇸Chattanooga, Tennessee, United States
Inquest Clinical Research /ID# 149755
🇺🇸Baytown, Texas, United States
Texas Health Presbyterian Hosp /ID# 149142
🇺🇸Dallas, Texas, United States
Baylor College of Medicine /ID# 149141
🇺🇸Houston, Texas, United States
FMC Science /ID# 151802
🇺🇸Lampasas, Texas, United States
Southampton Women's Health /ID# 152325
🇺🇸Franklin, Virginia, United States
Clinical Trials of Texas,Inc. /ID# 144322
🇺🇸San Antonio, Texas, United States
Tidewater Physicians for Women /ID# 144321
🇺🇸Norfolk, Virginia, United States
Zain Research /ID# 151018
🇺🇸Richland, Washington, United States
Medicor Research Inc. /ID# 153406
🇨🇦Sudbury, Ontario, Canada
Victory Reproductive Care /ID# 150247
🇨🇦Windsor, Ontario, Canada
Virginia Mason Medical Center /ID# 149758
🇺🇸Seattle, Washington, United States
University of South Florida /ID# 149754
🇺🇸Tampa, Florida, United States
Lotus Gynecology /ID# 149140
🇺🇸Austin, Texas, United States
University of Florida /ID# 149751
🇺🇸Gainesville, Florida, United States
Bluegrass Clinical Research /ID# 150103
🇺🇸Louisville, Kentucky, United States
Montefiore Medical Center /ID# 149582
🇺🇸Bronx, New York, United States
Women Under Study, LLC /ID# 144312
🇺🇸New Orleans, Louisiana, United States
Clinical Research Partners, LLC /ID# 144310
🇺🇸Richmond, Virginia, United States
Alliance Womens Health /ID# 152468
🇺🇸Richmond, Virginia, United States
Rowan University SOM /ID# 152697
🇺🇸Stratford, New Jersey, United States
Pinewest Ob-Gyn, Inc. /ID# 145671
🇺🇸High Point, North Carolina, United States