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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

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
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Elagolix, Elagolix Sodium, Heavy Uterine Bleeding, Heavy Menstrual Bleeding, Leiomyomata, Menorrhagia, ABT-620, Elagolix + E2/NETA, Elagolix + Norethindrone Acetate, HMB

Eligibility Criteria

18 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

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

  • Summers, Birmingham, AL /ID# 139684
  • University of South Alabama /ID# 148763
  • WCCT Global, LLC /ID# 145666
  • American Clinical Trials /ID# 147374
  • Grossmont Ctr Clin Research /ID# 144011
  • Long Beach Clinical Trial Serv /ID# 152424
  • National Research Institute /ID# 151629
  • University of California, Los Angeles /ID# 144107
  • Beach OBGYN Medical Group /ID# 151414
  • Advanced RX Clinical Research /ID# 149168
  • Bluebird Clinical Trials, LLC /ID# 144843
  • Advanced Women's Health Institution /ID# 144108
  • Medstar Health Research Institute /ID# 145933
  • James A. Simon, MD, PC /ID# 139675
  • Helix Biomedics, LLC /ID# 147114
  • Brandon Premier Health Care, PA /ID# 153130
  • Florida Clin Res Group /ID# 139811
  • Universal Clinical Research A /ID# 139742
  • Clinical Physiology Associates /ID# 139736
  • Meridien Research /ID# 139663
  • Altus Research, Inc /ID# 139662
  • South Florida Wellness & Clinic /ID# 143558
  • LCC Medical Research Institute /ID# 143551
  • Healthcare Clinical Data, Inc /ID# 139650
  • Ocean Blue Med Research Ctr /ID# 139826
  • Salom Tangir, LLC /ID# 151732
  • Advanced Research Institute /ID# 143554
  • Clinical Associates of Orlando /ID# 148123
  • Omega Research Consultants /ID# 139648
  • Unified Womens Clin Research /ID# 145169
  • Comprehensive Clinical Trials /ID# 139644
  • Atlanta Medical Research Insti /ID# 147117
  • Paramount Research Solutions /ID# 139645
  • Agile Clinical Research Trials /ID# 143563
  • Perimeter Inst Clinical Resear /ID# 148298
  • Masters of Clinical Research, Inc. /ID# 139658
  • Fellows Research Alliance, Inc /ID# 139655
  • Boise Family Medical Center /ID# 139844
  • Women's Health Practice, LLC /ID# 143569
  • Great Lakes Clinical Trials /ID# 148135
  • Affinity Clinical Research /ID# 150980
  • American Health Network of IN /ID# 139822
  • GTC Research /ID# 141854
  • Cypress Medical Research Ctr /ID# 147116
  • Research Integrity, LLC /ID# 139727
  • Clinical Trials Management, LLC - Covington /ID# 139651
  • Ochsner Baptist Medical Center /ID# 139740
  • Omni Fertility and Laser Insti /ID# 139836
  • Capital Women's Care /ID# 144109
  • Genesis Clinical Research - Fall River /ID# 148449
  • Great Lakes Research Group,Inc /ID# 139659
  • Grand Rapids Womens Health /ID# 139705
  • Wayne State University Physician Group - Southfield /ID# 139802
  • Office of Edmond E. Pack, MD /ID# 139792
  • Mabey, Las Vegas, NV /ID# 148138
  • Lawrence OB/GYN /ID# 143567
  • Bosque Women's Care /ID# 145934
  • Manhattan Medical Research /ID# 144471
  • Cwrwc /Id# 139664
  • Unified Women's Clinical Research-Greensboro /ID# 139829
  • Unified Women's Clinical Resea /ID# 139774
  • PMG Research of Wilmington LLC /ID# 152563
  • Unified Women's Clinical Resea /ID# 144721
  • University of Cincinnati /ID# 139820
  • Univ Hosp Cleveland /ID# 139741
  • Complete Healthcare for Women /ID# 139673
  • Miami Valley Hospital /ID# 144430
  • University of Toledo /ID# 139787
  • Legacy Medical Group-Portland /ID# 148807
  • Main Line Fertility Center /ID# 150295
  • Penn State University and Milton S. Hershey Medical Center /ID# 139733
  • Thomas Jefferson University /ID# 139812
  • Temple University Hospital /ID# 151429
  • Clinical Trials Research Svcs /ID# 139707
  • Medical University of South Carolina /ID# 148754
  • Vista Clinical Research /ID# 139797
  • WR-ClinSearch /ID# 143538
  • Research Memphis Associates, LLC /ID# 139674
  • Access Clinical Trials, Inc. /ID# 139730
  • UT Southwestern Medical Center /ID# 143537
  • Advances in Health, Inc. /ID# 139672
  • Victorium Clinical Research /ID# 149630
  • Discovery Clinical Trials-San Antonio /ID# 139776
  • Houston Ctr for Clin Research /ID# 149149
  • Center of Reproductive Medicin /ID# 139813
  • Eastern Virginia Med School /ID# 139647
  • Clinical Research Partners, LL /ID# 143999
  • Clinical Trials Virginia, Inc. /ID# 139801
  • Emerson Clinical Research /ID# 147373
  • Seattle Women's Health, Research, Gynecology /ID# 139768
  • Premier Clinical Research /ID# 148145
  • Froedtert and Medical College /ID# 143566
  • IWK Health Center /ID# 149066
  • The Ottawa Hospital /ID# 148695
  • Rodriguez-Ginorio, San Juan /ID# 139847
  • School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848

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
Change From Baseline in MBL Volume to Month 3
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

Full Information

First Posted
January 8, 2016
Last Updated
June 9, 2020
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02654054
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
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
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 22, 2015 (Actual)
Primary Completion Date
January 18, 2018 (Actual)
Study Completion Date
December 12, 2018 (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, Leiomyomata, Menorrhagia, ABT-620, Elagolix + E2/NETA, Elagolix + Norethindrone Acetate, HMB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
413 (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
Month 0 (Baseline), 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
Time Frame
Month 0 (Baseline), Month 6
Title
Change From Baseline in MBL Volume to Month 3
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
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
Summers, Birmingham, AL /ID# 139684
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
University of South Alabama /ID# 148763
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-3302
Country
United States
Facility Name
WCCT Global, LLC /ID# 145666
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
American Clinical Trials /ID# 147374
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
Grossmont Ctr Clin Research /ID# 144011
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Long Beach Clinical Trial Serv /ID# 152424
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
National Research Institute /ID# 151629
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
University of California, Los Angeles /ID# 144107
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Beach OBGYN Medical Group /ID# 151414
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-3657
Country
United States
Facility Name
Advanced RX Clinical Research /ID# 149168
City
Westminster
State/Province
California
ZIP/Postal Code
92683-4567
Country
United States
Facility Name
Bluebird Clinical Trials, LLC /ID# 144843
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Facility Name
Advanced Women's Health Institution /ID# 144108
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Medstar Health Research Institute /ID# 145933
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
James A. Simon, MD, PC /ID# 139675
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Helix Biomedics, LLC /ID# 147114
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436-6634
Country
United States
Facility Name
Brandon Premier Health Care, PA /ID# 153130
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510-3107
Country
United States
Facility Name
Florida Clin Res Group /ID# 139811
City
Ckearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Universal Clinical Research A /ID# 139742
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Clinical Physiology Associates /ID# 139736
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Meridien Research /ID# 139663
City
Kenneth City
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
Altus Research, Inc /ID# 139662
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
South Florida Wellness & Clinic /ID# 143558
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
LCC Medical Research Institute /ID# 143551
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Healthcare Clinical Data, Inc /ID# 139650
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Ocean Blue Med Research Ctr /ID# 139826
City
Miami
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Salom Tangir, LLC /ID# 151732
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Advanced Research Institute /ID# 143554
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Clinical Associates of Orlando /ID# 148123
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Omega Research Consultants /ID# 139648
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Unified Womens Clin Research /ID# 145169
City
Panama City
State/Province
Florida
ZIP/Postal Code
32045
Country
United States
Facility Name
Comprehensive Clinical Trials /ID# 139644
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Medical Research Insti /ID# 147117
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005-4419
Country
United States
Facility Name
Paramount Research Solutions /ID# 139645
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Agile Clinical Research Trials /ID# 143563
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Perimeter Inst Clinical Resear /ID# 148298
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Masters of Clinical Research, Inc. /ID# 139658
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Fellows Research Alliance, Inc /ID# 139655
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Boise Family Medical Center /ID# 139844
City
Boise
State/Province
Idaho
ZIP/Postal Code
83709
Country
United States
Facility Name
Women's Health Practice, LLC /ID# 143569
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Great Lakes Clinical Trials /ID# 148135
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Affinity Clinical Research /ID# 150980
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
American Health Network of IN /ID# 139822
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
GTC Research /ID# 141854
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Cypress Medical Research Ctr /ID# 147116
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Research Integrity, LLC /ID# 139727
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303-1089
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 139651
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Ochsner Baptist Medical Center /ID# 139740
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Omni Fertility and Laser Insti /ID# 139836
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
Capital Women's Care /ID# 144109
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21708
Country
United States
Facility Name
Genesis Clinical Research - Fall River /ID# 148449
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02723
Country
United States
Facility Name
Great Lakes Research Group,Inc /ID# 139659
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Grand Rapids Womens Health /ID# 139705
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Wayne State University Physician Group - Southfield /ID# 139802
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Office of Edmond E. Pack, MD /ID# 139792
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Mabey, Las Vegas, NV /ID# 148138
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Lawrence OB/GYN /ID# 143567
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Bosque Women's Care /ID# 145934
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Manhattan Medical Research /ID# 144471
City
New York
State/Province
New York
ZIP/Postal Code
10016-6023
Country
United States
Facility Name
Cwrwc /Id# 139664
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Unified Women's Clinical Research-Greensboro /ID# 139829
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Unified Women's Clinical Resea /ID# 139774
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
PMG Research of Wilmington LLC /ID# 152563
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Unified Women's Clinical Resea /ID# 144721
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati /ID# 139820
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Univ Hosp Cleveland /ID# 139741
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Complete Healthcare for Women /ID# 139673
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
Facility Name
Miami Valley Hospital /ID# 144430
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
University of Toledo /ID# 139787
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Legacy Medical Group-Portland /ID# 148807
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Main Line Fertility Center /ID# 150295
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 139733
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University /ID# 139812
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Facility Name
Temple University Hospital /ID# 151429
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Clinical Trials Research Svcs /ID# 139707
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Medical University of South Carolina /ID# 148754
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vista Clinical Research /ID# 139797
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
WR-ClinSearch /ID# 143538
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1605
Country
United States
Facility Name
Research Memphis Associates, LLC /ID# 139674
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-3895
Country
United States
Facility Name
Access Clinical Trials, Inc. /ID# 139730
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
UT Southwestern Medical Center /ID# 143537
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
Advances in Health, Inc. /ID# 139672
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Victorium Clinical Research /ID# 149630
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Discovery Clinical Trials-San Antonio /ID# 139776
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Houston Ctr for Clin Research /ID# 149149
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Center of Reproductive Medicin /ID# 139813
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Eastern Virginia Med School /ID# 139647
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
Facility Name
Clinical Research Partners, LL /ID# 143999
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235-4722
Country
United States
Facility Name
Clinical Trials Virginia, Inc. /ID# 139801
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Emerson Clinical Research /ID# 147373
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Facility Name
Seattle Women's Health, Research, Gynecology /ID# 139768
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Premier Clinical Research /ID# 148145
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Froedtert and Medical College /ID# 143566
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
IWK Health Center /ID# 149066
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
The Ottawa Hospital /ID# 148695
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Rodriguez-Ginorio, San Juan /ID# 139847
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

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
32702363
Citation
Al-Hendy A, Bradley L, Owens CD, Wang H, Barnhart KT, Feinberg E, Schlaff WD, Puscheck EE, Wang A, Gillispie V, Hurtado S, Muneyyirci-Delale O, Archer DF, Carr BR, Simon JA, Stewart EA. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021 Jan;224(1):72.e1-72.e50. doi: 10.1016/j.ajog.2020.07.032. Epub 2020 Jul 20.
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

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