Back to resultsEfficacy 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)
Primary Purpose
Uterine Fibroids, Heavy Menstrual Bleeding
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elagolix
Placebo for Estradiol/Norethindrone Acetate
Estradiol/Norethindrone Acetate
Placebo for Elagolix
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Elagolix, Elagolix Sodium, Heavy uterine bleeding, Heavy menstrual bleeding (HMB), Leiomyomata, Menorrhagia, ABT-620, Elagolix + E2/NETA (Elagolix + Norethindrone acetate)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Alabama Clinical Therapeutics, LLC /ID# 152258
- Choice Research, LLC /ID# 150988
- Brown, Pearson, Guepet Gynecology /ID# 151020
- Mobile, Ob-Gyn, P.C. /ID# 144294
- Mesa Obstetricians and Gynecol /ID# 149139
- Visions Clinical Research-Tucs /ID# 151017
- Core Healthcare Group /ID# 151016
- Diagnamics Inc. /ID# 152469
- HCP Clinical Research LLC /ID# 154434
- Alliance Research Centers /ID# 149752
- University of California, Los Angeles /ID# 149760
- Futura Research, Inc. /ID# 149759
- Farid Yasharpour MD Medical Co /ID# 149770
- Clinical Trial Investigators /ID# 152470
- Bayview Research Group LLC /ID# 153799
- Emerson Clinical Research Inst /ID# 152348
- Ideal Clinical Research Inc. /ID# 149757
- Seffner Premier Health Care, P /ID# 167480
- Olympian Clinical Research /ID# 149756
- KO Clinical Research, LLC /ID# 144299
- University of Florida /ID# 149751
- Solutions Through Adv Rch /ID# 151021
- Meridien Research /ID# 167100
- Precision Research Org, LLC /ID# 144335
- Invictus Clinical Research Group,LLC /ID# 141859
- Suncoast Clinical Research /ID# 149765
- All Wmns HC of West Broward /ID# 144298
- Oncova Clinical Research, Inc. /ID# 149764
- Physician Care Clin. Res., LLC /ID# 149766
- Qps-Mra, Llc /Id# 144325
- Martin Health System Center /ID# 152263
- University of South Florida /ID# 149754
- Axcess Medical Research /ID# 149769
- Virtus Research Consultant,LLC /ID# 144296
- Paramount Research Solutions /ID# 149291
- Agile Clinical Research Trials /ID# 167074
- Mount Vernon Clinical Res, LLC /ID# 144297
- Atlanta Women's Research Inst /ID# 144303
- Masters of Clinical Research, Inc. /ID# 167400
- Georgia Regents University /ID# 144295
- Meridian Clinical Research, LLC /ID# 149144
- Gyn-Care, Inc. /ID# 149341
- Atlanta Gynecology Research Institute /ID# 151014
- Womens Healthcare Assoc, DBA /ID# 149762
- Advanced Clinical Research /ID# 149767
- University of Chicago /ID# 152257
- Affinity Clinical Research /ID# 167119
- Center for Women's Research, Inc /ID# 144300
- Women's Health Advantage /ID# 144301
- The Iowa Clinic /ID# 150105
- PRN Professional Research Network of Kansas, LLC /ID# 152265
- Bluegrass Clinical Research /ID# 150103
- Clinical Trials Management, LLC - Covington /ID# 144314
- Women Under Study, LLC /ID# 144312
- Baltimore Suburban Health /ID# 154638
- Womens Health Center /ID# 154209
- Maryland Ctr for Sexual Health /ID# 149778
- NECCR Fall River LLC /ID# 149584
- Saginaw Valley Med Res Group /ID# 149768
- Accent Clinical Trials /ID# 149753
- Jersey Shore University Medical Center /ID# 149779
- Rowan University SOM /ID# 152697
- Montefiore Medical Center /ID# 149582
- SUNY Downstate Medical Center /ID# 144311
- Manhattan Medical Research /ID# 167077
- Weill Cornell Medicine /ID# 149585
- Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587
- Unified Women's Clinical Research-Greensboro /ID# 149588
- Pinewest Ob-Gyn, Inc. /ID# 145671
- Eastern Carolina Women's Centr /ID# 144309
- Wake Research Associates, LLC /ID# 144307
- Clinical Inquest Center Ltd /ID# 148728
- CTI Clinical Research Center /ID# 149761
- The Christ Hospital /ID# 150104
- Alpha Research Associates LLC /ID# 152471
- Comprehensive Womens Care /ID# 144306
- Family Medical Associates /ID# 145668
- University of Pennsylvania /ID# 149586
- Clinical Research of Philadelphia, LLC /ID# 151015
- Reading Hosp Clncl Trials Ofc /ID# 149583
- Holston Medical Group /ID# 149763
- Chattanooga Medical Research /ID# 145667
- Chattanooga Women for Women /ID# 167051
- The Jackson Clinic, PA /ID# 145670
- The Womens Physician Group /ID# 144317
- Access Clinical Trials, Inc. /ID# 167333
- Lotus Gynecology /ID# 149140
- Inquest Clinical Research /ID# 149755
- Texas Health Presbyterian Hosp /ID# 149142
- Baylor College of Medicine /ID# 149141
- The Woman's Hospital of Texas /ID# 144319
- Centex Studies, Inc. - Houston /ID# 150106
- BI Research Center /ID# 149143
- FMC Science /ID# 151802
- Willowbend Health and Wellness /ID# 144318
- Clinical Trials of Texas,Inc. /ID# 144322
- Center of Reproductive Medicin /ID# 167235
- Southampton Women's Health /ID# 152325
- Tidewater Physicians for Women /ID# 144321
- Clinical Research Partners, LLC /ID# 144310
- Alliance Womens Health /ID# 152468
- Zain Research /ID# 151018
- Virginia Mason Medical Center /ID# 149758
- Medicor Research Inc. /ID# 153406
- Victory Reproductive Care /ID# 150247
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Elagolix
Elagolix + E2/NETA
Arm Description
Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (QD)
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline in MBL Volume to the Final Month
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
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
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 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
Change From Baseline in MBL Volume to 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02691494
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 3, 2016 (Actual)
Primary Completion Date
February 14, 2018 (Actual)
Study Completion Date
January 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Heavy Menstrual Bleeding
Keywords
Elagolix, Elagolix Sodium, Heavy uterine bleeding, Heavy menstrual bleeding (HMB), Leiomyomata, Menorrhagia, ABT-620, Elagolix + E2/NETA (Elagolix + Norethindrone acetate)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
378 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (QD)
Arm Title
Elagolix
Arm Type
Experimental
Arm Description
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Arm Title
Elagolix + E2/NETA
Arm Type
Experimental
Arm Description
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Intervention Type
Drug
Intervention Name(s)
Elagolix
Other Intervention Name(s)
ABT-620, elagolix sodium
Intervention Description
Film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Placebo for Estradiol/Norethindrone Acetate
Intervention Description
Placebo capsules
Intervention Type
Drug
Intervention Name(s)
Estradiol/Norethindrone Acetate
Other Intervention Name(s)
E2/NETA
Intervention Description
Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
Intervention Type
Drug
Intervention Name(s)
Placebo for Elagolix
Intervention Description
Film-coated placebo tablets
Primary Outcome Measure Information:
Title
Percentage of Participants Meeting the Criteria for Responder
Description
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.
Time Frame
Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline in MBL Volume to the Final Month
Description
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.
Time Frame
Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Title
Percentage of Participants With Suppression of Bleeding at the Final Month
Description
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.
Time Frame
Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Title
Change From Baseline in MBL Volume to Month 6
Description
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.
Time Frame
Month 0 (Baseline), Month 6
Title
Change From Baseline in MBL Volume to Month 3
Description
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.
Time Frame
Month 0 (Baseline), Month 3
Title
Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6
Time Frame
Month 0 (Baseline), Month 6
Title
Change From Baseline in MBL Volume to Month 1
Description
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.
Time Frame
Month 0 (Baseline), Month 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics, LLC /ID# 152258
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Choice Research, LLC /ID# 150988
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Brown, Pearson, Guepet Gynecology /ID# 151020
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Mobile, Ob-Gyn, P.C. /ID# 144294
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Mesa Obstetricians and Gynecol /ID# 149139
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Facility Name
Visions Clinical Research-Tucs /ID# 151017
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Core Healthcare Group /ID# 151016
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Diagnamics Inc. /ID# 152469
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
HCP Clinical Research LLC /ID# 154434
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Alliance Research Centers /ID# 149752
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653-3621
Country
United States
Facility Name
University of California, Los Angeles /ID# 149760
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Futura Research, Inc. /ID# 149759
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Farid Yasharpour MD Medical Co /ID# 149770
City
San Fernando
State/Province
California
ZIP/Postal Code
91340
Country
United States
Facility Name
Clinical Trial Investigators /ID# 152470
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Bayview Research Group LLC /ID# 153799
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Emerson Clinical Research Inst /ID# 152348
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Ideal Clinical Research Inc. /ID# 149757
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Seffner Premier Health Care, P /ID# 167480
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510
Country
United States
Facility Name
Olympian Clinical Research /ID# 149756
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
KO Clinical Research, LLC /ID# 144299
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
University of Florida /ID# 149751
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Solutions Through Adv Rch /ID# 151021
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Meridien Research /ID# 167100
City
Kenneth City
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
Precision Research Org, LLC /ID# 144335
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016-1501
Country
United States
Facility Name
Invictus Clinical Research Group,LLC /ID# 141859
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Suncoast Clinical Research /ID# 149765
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
All Wmns HC of West Broward /ID# 144298
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Oncova Clinical Research, Inc. /ID# 149764
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Physician Care Clin. Res., LLC /ID# 149766
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Qps-Mra, Llc /Id# 144325
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Martin Health System Center /ID# 152263
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
University of South Florida /ID# 149754
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Axcess Medical Research /ID# 149769
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Virtus Research Consultant,LLC /ID# 144296
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Paramount Research Solutions /ID# 149291
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Agile Clinical Research Trials /ID# 167074
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Mount Vernon Clinical Res, LLC /ID# 144297
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Women's Research Inst /ID# 144303
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Masters of Clinical Research, Inc. /ID# 167400
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Georgia Regents University /ID# 144295
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Meridian Clinical Research, LLC /ID# 149144
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406-2675
Country
United States
Facility Name
Gyn-Care, Inc. /ID# 149341
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Atlanta Gynecology Research Institute /ID# 151014
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024-7159
Country
United States
Facility Name
Womens Healthcare Assoc, DBA /ID# 149762
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Advanced Clinical Research /ID# 149767
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
University of Chicago /ID# 152257
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Affinity Clinical Research /ID# 167119
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Center for Women's Research, Inc /ID# 144300
City
Palos Heights
State/Province
Illinois
ZIP/Postal Code
60463-1440
Country
United States
Facility Name
Women's Health Advantage /ID# 144301
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
The Iowa Clinic /ID# 150105
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
PRN Professional Research Network of Kansas, LLC /ID# 152265
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Bluegrass Clinical Research /ID# 150103
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 144314
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Women Under Study, LLC /ID# 144312
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125-1923
Country
United States
Facility Name
Baltimore Suburban Health /ID# 154638
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Womens Health Center /ID# 154209
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21063
Country
United States
Facility Name
Maryland Ctr for Sexual Health /ID# 149778
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
NECCR Fall River LLC /ID# 149584
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720-2972
Country
United States
Facility Name
Saginaw Valley Med Res Group /ID# 149768
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Accent Clinical Trials /ID# 149753
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106-4017
Country
United States
Facility Name
Jersey Shore University Medical Center /ID# 149779
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753-4859
Country
United States
Facility Name
Rowan University SOM /ID# 152697
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Montefiore Medical Center /ID# 149582
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY Downstate Medical Center /ID# 144311
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Manhattan Medical Research /ID# 167077
City
New York
State/Province
New York
ZIP/Postal Code
10016-6023
Country
United States
Facility Name
Weill Cornell Medicine /ID# 149585
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Unified Women's Clinical Research-Greensboro /ID# 149588
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Pinewest Ob-Gyn, Inc. /ID# 145671
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Eastern Carolina Women's Centr /ID# 144309
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Wake Research Associates, LLC /ID# 144307
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Clinical Inquest Center Ltd /ID# 148728
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
CTI Clinical Research Center /ID# 149761
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
The Christ Hospital /ID# 150104
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Alpha Research Associates LLC /ID# 152471
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Comprehensive Womens Care /ID# 144306
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Family Medical Associates /ID# 145668
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
University of Pennsylvania /ID# 149586
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC /ID# 151015
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Reading Hosp Clncl Trials Ofc /ID# 149583
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Holston Medical Group /ID# 149763
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620-7346
Country
United States
Facility Name
Chattanooga Medical Research /ID# 145667
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Chattanooga Women for Women /ID# 167051
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343-3992
Country
United States
Facility Name
The Jackson Clinic, PA /ID# 145670
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
The Womens Physician Group /ID# 144317
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Access Clinical Trials, Inc. /ID# 167333
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Lotus Gynecology /ID# 149140
City
Austin
State/Province
Texas
ZIP/Postal Code
78703-1448
Country
United States
Facility Name
Inquest Clinical Research /ID# 149755
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521-2415
Country
United States
Facility Name
Texas Health Presbyterian Hosp /ID# 149142
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College of Medicine /ID# 149141
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
The Woman's Hospital of Texas /ID# 144319
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 150106
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
BI Research Center /ID# 149143
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
FMC Science /ID# 151802
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Willowbend Health and Wellness /ID# 144318
City
Plano
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Facility Name
Clinical Trials of Texas,Inc. /ID# 144322
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center of Reproductive Medicin /ID# 167235
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Southampton Women's Health /ID# 152325
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Facility Name
Tidewater Physicians for Women /ID# 144321
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Clinical Research Partners, LLC /ID# 144310
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220-4459
Country
United States
Facility Name
Alliance Womens Health /ID# 152468
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226-1930
Country
United States
Facility Name
Zain Research /ID# 151018
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 149758
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Medicor Research Inc. /ID# 153406
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Victory Reproductive Care /ID# 150247
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5R7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
34878624
Citation
Beck 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.
Results Reference
derived
PubMed Identifier
34582715
Citation
Stewart 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.
Results Reference
derived
PubMed Identifier
34553161
Citation
Muneyyirci-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.
Results Reference
derived
PubMed Identifier
33650259
Citation
Beck 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. Erratum In: Clin Transl Sci. 2022 Mar;15(3):799.
Results Reference
derived
PubMed Identifier
31971678
Citation
Schlaff 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.
Results Reference
derived
Learn more about this trial
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)
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