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An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Primary Purpose

Uterine Fibroids, Heavy Menstrual Bleeding

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Estradiol/Norethindrone Acetate
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 Uterine Fibroids, Elagolix, Heavy Menstrual Bleeding, Elagolix Sodium, Elagolix plus Norethindrone Acetate

Eligibility Criteria

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

Inclusion Criteria:

  • Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
  • Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
  • Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
  • Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.

Exclusion Criteria:

  • Participant met criteria for removal from therapy in her respective Pivotal Study.
  • Participant is planning a pregnancy within the next 18 months.
  • Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
  • Participant has any new medical conditions that may be unsuitable for participation.
  • Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.

Sites / Locations

  • Alabama Clinical Therapeutics, LLC /ID# 153217
  • Alabama Clinical Therapeutics, LLC /ID# 153336
  • Choice Research, LLC /ID# 153492
  • Brown, Pearson, Guepet Gynecology /ID# 153278
  • University of South Alabama /ID# 153415
  • Mobile, Ob-Gyn, P.C. /ID# 153442
  • Mesa Obstetricians and Gynecol /ID# 153269
  • Core Healthcare Group /ID# 153282
  • Diagnamics Inc. /ID# 153347
  • Grossmont Ctr Clin Research /ID# 153324
  • Futura Research, Inc. /ID# 153345
  • Farid Yasharpour MD Medical Co /ID# 153482
  • Advanced Women's Health Institution /ID# 153401
  • Medstar Health Research Institute /ID# 153321
  • Emerson Clinical Research Inst /ID# 162755
  • James A. Simon, MD, PC /ID# 153323
  • Helix Biomedics, LLC /ID# 153440
  • Brandon Premier Health Care, PA /ID# 165791
  • Florida Fertility Institute /ID# 153308
  • Omega Research Consultants, LLC /ID# 153381
  • KO Clinical Research, LLC /ID# 153198
  • Clinical Physiology Assoc. /ID# 153444
  • Solutions Through Adv Rch /ID# 153283
  • Meridien Research /ID# 153310
  • Altus Research, Inc /ID# 153307
  • South Florida Wellness & Clinic /ID# 153420
  • Precision Research Org, LLC /ID# 153276
  • LCC Medical Research Institute /ID# 153296
  • Invictus Clinical Research Group,LLC /ID# 153196
  • Healthcare Clinical Data, Inc /ID# 153425
  • Ocean Blue Med Research Ctr /ID# 153225
  • Suncoast Clinical Research /ID# 153206
  • Advanced Research Institute /ID# 153413
  • Clinical Associates of Orlando /ID# 153427
  • Unified Womens Clin Research /ID# 153229
  • All Wmns HC of West Broward /ID# 153434
  • Oncova Clinical Research, Inc. /ID# 153497
  • Physician Care Clin. Res., LLC /ID# 153210
  • Qps-Mra, Llc /Id# 153456
  • University of South Florida /ID# 153271
  • Axcess Medical Research /ID# 153500
  • Virtus Research Consultant,LLC /ID# 153398
  • Comprehensive Clinical Trials /ID# 153350
  • Atlanta Medical Research Insti /ID# 153298
  • Paramount Research Solutions /ID# 153424
  • Paramount Research Solutions /ID# 160974
  • Mount Vernon Clinical Res, LLC /ID# 153403
  • Atlanta Women's Research Inst /ID# 153212
  • Masters of Clinical Research, Inc. /ID# 153295
  • Paramount Research Solutions /ID# 153351
  • Fellows Research Alliance, Inc /ID# 153227
  • Clinical Research Consultants of Atlanta /ID# 153285
  • Atlanta Gynecology Research Institute /ID# 200074
  • Sonora Clinical Research /ID# 153231
  • Affinity Clinical Research /ID# 153417
  • Bluegrass Clinical Research /ID# 153280
  • Clinical Trials Management, LLC - Covington /ID# 153211
  • Clinical Trials Management, LLC - Covington /ID# 153439
  • Ochsner Baptist Medical Center /ID# 153459
  • Omni Fertility and Laser Insti /ID# 153228
  • Baltimore Suburban Health /ID# 168386
  • NECCR Fall River LLC /ID# 153274
  • Genesis Clinical Research /ID# 153379
  • Great Lakes Research Group,Inc /ID# 153302
  • Saginaw Valley Med Res Group /ID# 153498
  • Wayne State University Physician Group - Southfield /ID# 153418
  • Accent Clinical Trials /ID# 153474
  • Office of Edmond E. Pack, MD /ID# 153411
  • Mabey, Las Vegas, NV /ID# 153314
  • Lawrence OB/GYN /ID# 153218
  • Jersey Shore University Medical Center /ID# 153495
  • Bosque Women's Care /ID# 153223
  • SUNY Downstate Medical Center /ID# 153344
  • Manhattan Medical Research /ID# 153386
  • Weill Cornell Medicine /ID# 153275
  • Cwrwc /Id# 153313
  • Unified Women's Clinical Research-Greensboro /ID# 153499
  • Pinewest Ob-Gyn, Inc. /ID# 153197
  • Eastern Carolina Women's Centr /ID# 153341
  • Unified Women's Clinical Resea /ID# 153312
  • Wake Research Associates, LLC /ID# 153402
  • Unified Women's Clinical Resea /ID# 153297
  • Clinical Inquest Center Ltd /ID# 153436
  • CTI Clinical Research Center /ID# 153201
  • University Hospitals Cleveland /ID# 153450
  • University of Toledo /ID# 153409
  • Comprehensive Womens Care /ID# 153396
  • Legacy Medical Group-Portland /ID# 168286
  • Main Line Fertility Center /ID# 153410
  • Penn State University and Milton S. Hershey Medical Center /ID# 153443
  • University of Pennsylvania /ID# 153203
  • Thomas Jefferson University /ID# 153319
  • Clinical Research of Philadelphia, LLC /ID# 153279
  • Reading Hosp Clncl Trials Ofc /ID# 153475
  • Medical University of South Carolina /ID# 153325
  • Vista Clinical Research /ID# 153399
  • Chattanooga Medical Research /ID# 153405
  • WR-ClinSearch /ID# 153404
  • Research Memphis Associates, LLC /ID# 153322
  • Women's Health Trials /ID# 153426
  • Access Clinical Trials, Inc. /ID# 153441
  • Lotus Gynecology /ID# 153476
  • Texas Health Presbyterian Hosp /ID# 153339
  • UT Southwestern Medical Center /ID# 153400
  • Baylor Scott & White /ID# 153273
  • Willowbend Health and Wellness /ID# 153458
  • Advances in Health, Inc. /ID# 153414
  • The Woman's Hospital of Texas /ID# 153270
  • FMC Science /ID# 153289
  • Clinical Trials of Texas,Inc. /ID# 153209
  • Discovery Clinical Trials-San Antonio /ID# 153315
  • Houston Ctr for Clin Research /ID# 153221
  • Center of Reproductive Medicin /ID# 153320
  • Tidewater Physicians for Women /ID# 153432
  • Eastern Virginia Med School /ID# 153380
  • Clinical Research Partners, LL /ID# 153412
  • Clinical Research Partners, LLC /ID# 153343
  • Clinical Trials Virginia, Inc. /ID# 153419
  • Emerson Clinical Research Inst /ID# 153416
  • Virginia Mason Medical Center /ID# 153342
  • Seattle Women's Health, Research, Gynecology /ID# 153306
  • Victory Reproductive Care /ID# 153299
  • Rodriguez-Ginorio, San Juan /ID# 153328
  • School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)

Elagolix

Arm Description

Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD)

Elagolix 300 mg BID and placebo for 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 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 For Each 28-Day Interval and Final Month of the Treatment Period
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Percentage of Participants With 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.
Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period

Full Information

First Posted
September 24, 2016
Last Updated
July 9, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02925494
Brief Title
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Official Title
Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
May 7, 2018 (Actual)
Study Completion Date
March 22, 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 is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.

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
Uterine Fibroids, Elagolix, Heavy Menstrual Bleeding, Elagolix Sodium, Elagolix plus Norethindrone Acetate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
433 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)
Arm Type
Experimental
Arm Description
Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) 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
Intervention Type
Drug
Intervention Name(s)
Estradiol/Norethindrone Acetate
Intervention Description
capsules
Intervention Type
Drug
Intervention Name(s)
Elagolix
Other Intervention Name(s)
ABT-620, elagolix sodium
Intervention Description
film-coated 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 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
From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)
Secondary Outcome Measure Information:
Title
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Description
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Time Frame
Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
Title
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Description
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Time Frame
Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
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.
Time Frame
Final Month of Treatment Period (up through Month 6)
Title
Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period
Time Frame
Month 6

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: Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817). Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study. Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology. Exclusion Criteria: Participant met criteria for removal from therapy in her respective Pivotal Study. Participant is planning a pregnancy within the next 18 months. Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study. Participant has any new medical conditions that may be unsuitable for participation. Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
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# 153217
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Alabama Clinical Therapeutics, LLC /ID# 153336
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Choice Research, LLC /ID# 153492
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Brown, Pearson, Guepet Gynecology /ID# 153278
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
University of South Alabama /ID# 153415
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-3302
Country
United States
Facility Name
Mobile, Ob-Gyn, P.C. /ID# 153442
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Mesa Obstetricians and Gynecol /ID# 153269
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Facility Name
Core Healthcare Group /ID# 153282
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Diagnamics Inc. /ID# 153347
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Grossmont Ctr Clin Research /ID# 153324
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Futura Research, Inc. /ID# 153345
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Farid Yasharpour MD Medical Co /ID# 153482
City
San Fernando
State/Province
California
ZIP/Postal Code
91340
Country
United States
Facility Name
Advanced Women's Health Institution /ID# 153401
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Medstar Health Research Institute /ID# 153321
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emerson Clinical Research Inst /ID# 162755
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
James A. Simon, MD, PC /ID# 153323
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Helix Biomedics, LLC /ID# 153440
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436-6634
Country
United States
Facility Name
Brandon Premier Health Care, PA /ID# 165791
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510-3107
Country
United States
Facility Name
Florida Fertility Institute /ID# 153308
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Omega Research Consultants, LLC /ID# 153381
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
KO Clinical Research, LLC /ID# 153198
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Clinical Physiology Assoc. /ID# 153444
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Solutions Through Adv Rch /ID# 153283
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Meridien Research /ID# 153310
City
Kenneth City
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
Altus Research, Inc /ID# 153307
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
South Florida Wellness & Clinic /ID# 153420
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Precision Research Org, LLC /ID# 153276
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016-1501
Country
United States
Facility Name
LCC Medical Research Institute /ID# 153296
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Invictus Clinical Research Group,LLC /ID# 153196
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Healthcare Clinical Data, Inc /ID# 153425
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Ocean Blue Med Research Ctr /ID# 153225
City
Miami
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Suncoast Clinical Research /ID# 153206
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Advanced Research Institute /ID# 153413
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Clinical Associates of Orlando /ID# 153427
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Unified Womens Clin Research /ID# 153229
City
Panama City
State/Province
Florida
ZIP/Postal Code
32045
Country
United States
Facility Name
All Wmns HC of West Broward /ID# 153434
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Oncova Clinical Research, Inc. /ID# 153497
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Physician Care Clin. Res., LLC /ID# 153210
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Qps-Mra, Llc /Id# 153456
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
University of South Florida /ID# 153271
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Axcess Medical Research /ID# 153500
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Virtus Research Consultant,LLC /ID# 153398
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Comprehensive Clinical Trials /ID# 153350
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Medical Research Insti /ID# 153298
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005-4419
Country
United States
Facility Name
Paramount Research Solutions /ID# 153424
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Paramount Research Solutions /ID# 160974
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Mount Vernon Clinical Res, LLC /ID# 153403
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Women's Research Inst /ID# 153212
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Masters of Clinical Research, Inc. /ID# 153295
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Paramount Research Solutions /ID# 153351
City
College Park
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Facility Name
Fellows Research Alliance, Inc /ID# 153227
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Consultants of Atlanta /ID# 153285
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024-6988
Country
United States
Facility Name
Atlanta Gynecology Research Institute /ID# 200074
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024-7159
Country
United States
Facility Name
Sonora Clinical Research /ID# 153231
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646-1144
Country
United States
Facility Name
Affinity Clinical Research /ID# 153417
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Bluegrass Clinical Research /ID# 153280
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 153211
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 153439
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Ochsner Baptist Medical Center /ID# 153459
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Omni Fertility and Laser Insti /ID# 153228
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
Baltimore Suburban Health /ID# 168386
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
NECCR Fall River LLC /ID# 153274
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720-2972
Country
United States
Facility Name
Genesis Clinical Research /ID# 153379
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Great Lakes Research Group,Inc /ID# 153302
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Saginaw Valley Med Res Group /ID# 153498
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Wayne State University Physician Group - Southfield /ID# 153418
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Accent Clinical Trials /ID# 153474
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106-4017
Country
United States
Facility Name
Office of Edmond E. Pack, MD /ID# 153411
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Mabey, Las Vegas, NV /ID# 153314
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Lawrence OB/GYN /ID# 153218
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Jersey Shore University Medical Center /ID# 153495
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753-4859
Country
United States
Facility Name
Bosque Women's Care /ID# 153223
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
SUNY Downstate Medical Center /ID# 153344
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Manhattan Medical Research /ID# 153386
City
New York
State/Province
New York
ZIP/Postal Code
10016-6023
Country
United States
Facility Name
Weill Cornell Medicine /ID# 153275
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Cwrwc /Id# 153313
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Unified Women's Clinical Research-Greensboro /ID# 153499
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Pinewest Ob-Gyn, Inc. /ID# 153197
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Eastern Carolina Women's Centr /ID# 153341
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Unified Women's Clinical Resea /ID# 153312
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Research Associates, LLC /ID# 153402
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Unified Women's Clinical Resea /ID# 153297
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Inquest Center Ltd /ID# 153436
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
CTI Clinical Research Center /ID# 153201
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
University Hospitals Cleveland /ID# 153450
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Toledo /ID# 153409
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Comprehensive Womens Care /ID# 153396
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Legacy Medical Group-Portland /ID# 168286
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Main Line Fertility Center /ID# 153410
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# 153443
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania /ID# 153203
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Thomas Jefferson University /ID# 153319
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC /ID# 153279
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Reading Hosp Clncl Trials Ofc /ID# 153475
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Medical University of South Carolina /ID# 153325
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vista Clinical Research /ID# 153399
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Chattanooga Medical Research /ID# 153405
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
WR-ClinSearch /ID# 153404
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1605
Country
United States
Facility Name
Research Memphis Associates, LLC /ID# 153322
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-3895
Country
United States
Facility Name
Women's Health Trials /ID# 153426
City
Menphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Access Clinical Trials, Inc. /ID# 153441
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Lotus Gynecology /ID# 153476
City
Austin
State/Province
Texas
ZIP/Postal Code
78703-1448
Country
United States
Facility Name
Texas Health Presbyterian Hosp /ID# 153339
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
UT Southwestern Medical Center /ID# 153400
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
Baylor Scott & White /ID# 153273
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-4110
Country
United States
Facility Name
Willowbend Health and Wellness /ID# 153458
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Facility Name
Advances in Health, Inc. /ID# 153414
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Woman's Hospital of Texas /ID# 153270
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
FMC Science /ID# 153289
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Clinical Trials of Texas,Inc. /ID# 153209
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Discovery Clinical Trials-San Antonio /ID# 153315
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Houston Ctr for Clin Research /ID# 153221
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Center of Reproductive Medicin /ID# 153320
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Tidewater Physicians for Women /ID# 153432
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Eastern Virginia Med School /ID# 153380
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
Facility Name
Clinical Research Partners, LL /ID# 153412
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235-4722
Country
United States
Facility Name
Clinical Research Partners, LLC /ID# 153343
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220-4459
Country
United States
Facility Name
Clinical Trials Virginia, Inc. /ID# 153419
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Emerson Clinical Research Inst /ID# 153416
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 153342
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Women's Health, Research, Gynecology /ID# 153306
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Victory Reproductive Care /ID# 153299
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5R7
Country
Canada
Facility Name
Rodriguez-Ginorio, San Juan /ID# 153328
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329
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
32459423
Citation
Simon JA, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Dayspring T, Feinberg EC, Gillispie V, Hurtado S, Kim J, Liu R, Owens CD, Muneyyirci-Delale O, Wang A, Watts NB, Schlaff WD. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstet Gynecol. 2020 Jun;135(6):1313-1326. doi: 10.1097/AOG.0000000000003869.
Results Reference
background
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

Learn more about this trial

An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

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