search
Back to results

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Primary Purpose

Heavy Menstrual Bleeding, Uterine Fibroids

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elagolix Placebo
E2/NETA
E2/NETA Placebo
Elagolix
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant is a premenopausal female at the time of Screening.
  • Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound [Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].
  • Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) > 80 mL during each of two screening menses as measured by the alkaline hematin method.
  • Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose.
  • Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.

Exclusion Criteria:

  • Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder.
  • Participant has history of osteoporosis or other metabolic bone disease.
  • Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
  • Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
  • Participant 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 intra-articular injectable (for occasional use) corticosteroids are allowed.

Sites / Locations

  • Alabama Clinical Therapeutics /ID# 160835
  • Alabama Clinical Therapeutics /ID# 160927
  • Choice Research, LLC /ID# 161498
  • Southern Women's Specialists PC /ID# 161531
  • E Squared Research /ID# 163645
  • Women's Health Alliance of Mobile /ID# 161443
  • Mobile, OBGYN P.C. /ID# 161530
  • Mesa Obstetricians and Gynecologists /ID# 160955
  • Noble Clinical Research /ID# 166949
  • Vision's Clinical Research-Tucson /ID# 161508
  • Eclipse Clinical Research /ID# 161516
  • Core Healthcare Group /ID# 160858
  • Diagnamics Inc. /ID# 160950
  • HRC Fertility /ID# 161493
  • SC Clinical Research /ID# 164395
  • Duplicate_Duplicate_Marvel Clinical Research /ID# 167297
  • Grossmont Ctr Clin Research /ID# 165120
  • Olympia Clinical Trials /ID# 201562
  • National Research Institute /ID# 160952
  • Futura Research, Org /ID# 160924
  • California Medical Research Associates /ID# 161481
  • Northern California Research /ID# 161561
  • Precision Research Institute - San Diego /ID# 163069
  • MD Strategies Research Centers /ID# 161544
  • Health care Affiliates Medical Group /ID# 163324
  • Alta California Medical Group /ID# 163564
  • Upland Clinical Research /ID# 164528
  • Bayview Research Group LLC /ID# 161484
  • Advanced RX Clinical Research /ID# 161599
  • Emerson Clinical Research Inst /ID# 162181
  • James A. Simon, MD, PC /ID# 160931
  • Women's Health Partners /ID# 203577
  • David Lubetkin MD LLC /ID# 203578
  • Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910
  • Omega Research Maitland, LLC /ID# 160857
  • Midland Florida Clinical Research Center /ID# 161487
  • KO Clinical Research, LLC /ID# 160928
  • Sweet Hope Research Specialty Inc /ID# 163522
  • Solutions Through Adv Rch /ID# 160935
  • Altus Research, Inc /ID# 160912
  • Wellington Anti-Aging Centre /ID# 203540
  • South Florida Wellness & Clinic /ID# 161535
  • Duplicate_Precision Research Organization /ID# 161522
  • Ocean Blue Medical Research Center, Inc /ID# 161549
  • Invictus Clinical Research Group,LLC /ID# 160925
  • Healthcare Clinical Data, Inc /ID# 160888
  • Palmetto Professional Research /ID# 161442
  • Vista Health Research, LLC /ID# 163044
  • Salom Tangir, LLC /ID# 162542
  • Advanced Research Institute, Inc /ID# 163748
  • A Premier Medical Research of FL /ID# 201882
  • Clinical Associates of Orlando /ID# 160889
  • Oncova Clinical Research, Inc. /ID# 160937
  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913
  • Physician Care Clin. Res., LLC /ID# 161547
  • Treasure Coast Research /ID# 161824
  • Discovery Clinical Research /ID# 160891
  • Precision Clinical Research /ID# 165377
  • GCP Clinical Research, LLC /ID# 164593
  • University of South Florida /ID# 160960
  • Jedidiah Clinical Research /ID# 167114
  • Virtus Research Consultants, LLC /ID# 160855
  • Comprehensive Clinical Trials LLC /ID# 161479
  • Journey Medical Research Insti /ID# 160958
  • Paramount Research Solutions /ID# 161557
  • Agile Clinical Research Trials /ID# 160941
  • Mount Vernon Clinical Res, LLC /ID# 161491
  • Atlanta Women's Research Institute /ID# 160844
  • Medisense Inc /ID# 161494
  • Duplicate_Atlanta Gynecology Research Institute /ID# 160851
  • Bingham Memorial Hospital /ID# 201130
  • Leavitt Womens Healthcare /ID# 163419
  • Womens Healthcare Assoc, DBA /ID# 160933
  • Sonora Clinical Research /ID# 167610
  • Asr, Llc /Id# 162179
  • Women's Health Practice, LLC /ID# 161553
  • Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118
  • Duplicate_University of Chicago /ID# 162667
  • Affinity Clinical Research /ID# 160932
  • Women's Health Advantage /ID# 161537
  • Womens & Family Care, LLC dba /ID# 160890
  • Bluegrass Clinical Research /ID# 163485
  • Clinical Trials Management, LLC - Covington /ID# 160838
  • Clinical Trials Management, LLC - Covington /ID# 160893
  • Praetorian Pharmaceutical Research /ID# 161532
  • Ochsner Baptist Medical Centre /ID# 161507
  • Women Under Study, LLC /ID# 163990
  • Willis-Knighton Pediatric GI S /ID# 161534
  • Exordia Medical Research, Inc /ID# 160853
  • Great Lakes Research Group, Inc. /ID# 161511
  • Wayne State University /ID# 160944
  • Valley OB-Gyn Clinic - Saginaw /ID# 203579
  • Saginaw Valley Med Res Group /ID# 160840
  • Quad Clinical Research, LLC /ID# 200943
  • Excel Clinical Research /ID# 165588
  • Office of Edmond E. Pack, MD /ID# 162604
  • Private practice: Dr. Rex G. Mabey JR /ID# 160915
  • Jersey Shore University Medical Center /ID# 160916
  • Lovelace Scientific Resources /ID# 163644
  • Bosque Women's Care /ID# 162606
  • SUNY Downstate Medical Center /ID# 160922
  • Duplicate_Northwell Health System - Manhasset /ID# 201058
  • Columbia Univ Medical Center /ID# 161519
  • Hamburg Regional Gynecology Gr /ID# 161427
  • DJL Clinical Research, PLLC /ID# 161548
  • Carolina Women's Research and Wellness Center /ID# 160914
  • Unified Women's Clinical Resea /ID# 163014
  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490
  • Unified Women's Clinical Resea /ID# 160957
  • Clinical Inquest Center Ltd /ID# 160892
  • CTI Clinical Research Center /ID# 160942
  • Univ Hosp Cleveland /ID# 160953
  • Central Ohio Clinical Research /ID# 201162
  • Duplicate_Optimed Research /ID# 165600
  • Hilltop Obstetrics & Gynecology /ID# 203576
  • University of Toledo /ID# 160923
  • Oregon Health and Science University /ID# 161514
  • OB/GYN Associates of Erie /ID# 161541
  • Penn State University and Milton S. Hershey Medical Center /ID# 160896
  • University of Pennsylvania /ID# 160936
  • DUP_Thomas Jefferson University /ID# 200304
  • Vista Clinical Research /ID# 160946
  • VitaLink Research-Spartanburg /ID# 164592
  • Chattanooga Medical Research /ID# 160885
  • WR-ClinSearch /ID# 160887
  • The Jackson Clinic, PA /ID# 162496
  • Research Memphis Associates, LLC /ID# 160939
  • OBGYN North /ID# 203580
  • Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542
  • Discovery Clinical Trials -HCWC /ID# 161543
  • Duplicate_The University of Texas Southwestern Medical Center /ID# 161496
  • Baylor Scott & White /ID# 161515
  • Willowbend Health and Wellness - Frisco /ID# 160954
  • Advances in Health, Inc. /ID# 160930
  • The Ob/Gyn Center /ID# 165928
  • Precision Research Institute, LLC /ID# 161554
  • The Woman's Hospital of Texas /ID# 160959
  • Centex Studies, Inc /ID# 163858
  • Centex Studies, Inc. - Houston /ID# 160917
  • UAG Innovation Women Research, /ID# 167415
  • America's Adv. Wellness Center /ID# 167548
  • FMC Science /ID# 160886
  • ClinRx Research, LLC /ID# 201170
  • Clinical Trials of Texas, Inc /ID# 161510
  • VIP Trials /ID# 161546
  • Houston Ctr for Clin Research /ID# 160837
  • The Univ Texas HSC at Tyler /ID# 161533
  • Center of Reproductive Medicine /ID# 162498
  • Univ of Virgnia Medical center /ID# 166283
  • Eastern Virginia Med School /ID# 160856
  • Clinical Research Partners /ID# 160929
  • Clinical Research Partners /ID# 160948
  • Clinical Trials Virginia, Inc. /ID# 160943
  • Specialists for Women /ID# 201129
  • Tidewater Clinical Research /ID# 160949
  • Henry A. Rodriguez Ginorio, MD /ID# 160861
  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Elagolix plus estradiol (E2)/norethindrone acetate (NETA)

Placebo

Arm Description

Elagolix plus estradiol (E2)/norethindrone acetate (NETA)

Placebo

Outcomes

Primary Outcome Measures

Change in Bone Mineral Density (BMD)
Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).

Secondary Outcome Measures

Full Information

First Posted
August 31, 2017
Last Updated
February 14, 2023
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT03271489
Brief Title
Long-Term Safety Study 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 3b Study to Evaluate the Long-Term 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
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
November 27, 2023 (Anticipated)
Study Completion Date
July 2, 2024 (Anticipated)

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
No

5. Study Description

Brief Summary
This is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label for the next three years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Menstrual Bleeding, Uterine Fibroids
Keywords
Elagolix Sodium, Heavy Menstrual Bleeding (HMB), Heavy Uterine Bleeding, Leiomyomata, Menorrhagia, Elagolix + Norethindrone Acetate, Elagolix + E2/NETA, Elagolix, Safety, Efficacy, ABT-620

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Arm Type
Experimental
Arm Description
Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Other
Intervention Name(s)
Elagolix Placebo
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
E2/NETA
Intervention Description
Capsules
Intervention Type
Other
Intervention Name(s)
E2/NETA Placebo
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Elagolix
Other Intervention Name(s)
ABT-620 Elagolix sodium
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Change in Bone Mineral Density (BMD)
Description
Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).
Time Frame
From Baseline through Month 48

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is a premenopausal female at the time of Screening. Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound [Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)]. Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) > 80 mL during each of two screening menses as measured by the alkaline hematin method. Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose. Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology. Exclusion Criteria: Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder. Participant has history of osteoporosis or other metabolic bone disease. Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). Participant 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 intra-articular 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 /ID# 160835
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Alabama Clinical Therapeutics /ID# 160927
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Choice Research, LLC /ID# 161498
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Southern Women's Specialists PC /ID# 161531
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532-3029
Country
United States
Facility Name
E Squared Research /ID# 163645
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Women's Health Alliance of Mobile /ID# 161443
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-1410
Country
United States
Facility Name
Mobile, OBGYN P.C. /ID# 161530
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Mesa Obstetricians and Gynecologists /ID# 160955
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Facility Name
Noble Clinical Research /ID# 166949
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Vision's Clinical Research-Tucson /ID# 161508
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Eclipse Clinical Research /ID# 161516
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Core Healthcare Group /ID# 160858
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Diagnamics Inc. /ID# 160950
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
HRC Fertility /ID# 161493
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
SC Clinical Research /ID# 164395
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Duplicate_Duplicate_Marvel Clinical Research /ID# 167297
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Grossmont Ctr Clin Research /ID# 165120
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Olympia Clinical Trials /ID# 201562
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036-4667
Country
United States
Facility Name
National Research Institute /ID# 160952
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Futura Research, Org /ID# 160924
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
California Medical Research Associates /ID# 161481
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Northern California Research /ID# 161561
City
Sacramento
State/Province
California
ZIP/Postal Code
95821-2640
Country
United States
Facility Name
Precision Research Institute - San Diego /ID# 163069
City
San Diego
State/Province
California
ZIP/Postal Code
92114-3643
Country
United States
Facility Name
MD Strategies Research Centers /ID# 161544
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Health care Affiliates Medical Group /ID# 163324
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Alta California Medical Group /ID# 163564
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Upland Clinical Research /ID# 164528
City
Upland
State/Province
California
ZIP/Postal Code
91786-4027
Country
United States
Facility Name
Bayview Research Group LLC /ID# 161484
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Advanced RX Clinical Research /ID# 161599
City
Westminster
State/Province
California
ZIP/Postal Code
92683-4567
Country
United States
Facility Name
Emerson Clinical Research Inst /ID# 162181
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
James A. Simon, MD, PC /ID# 160931
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Women's Health Partners /ID# 203577
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33433-7041
Country
United States
Facility Name
David Lubetkin MD LLC /ID# 203578
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486-2269
Country
United States
Facility Name
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510-3107
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 160857
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
Midland Florida Clinical Research Center /ID# 161487
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720-0920
Country
United States
Facility Name
KO Clinical Research, LLC /ID# 160928
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Sweet Hope Research Specialty Inc /ID# 163522
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1897
Country
United States
Facility Name
Solutions Through Adv Rch /ID# 160935
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Altus Research, Inc /ID# 160912
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Wellington Anti-Aging Centre /ID# 203540
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470-4937
Country
United States
Facility Name
South Florida Wellness & Clinic /ID# 161535
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Duplicate_Precision Research Organization /ID# 161522
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016-1501
Country
United States
Facility Name
Ocean Blue Medical Research Center, Inc /ID# 161549
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Invictus Clinical Research Group,LLC /ID# 160925
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Healthcare Clinical Data, Inc /ID# 160888
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Palmetto Professional Research /ID# 161442
City
Miami
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Vista Health Research, LLC /ID# 163044
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-1032
Country
United States
Facility Name
Salom Tangir, LLC /ID# 162542
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Advanced Research Institute, Inc /ID# 163748
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
A Premier Medical Research of FL /ID# 201882
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763-2833
Country
United States
Facility Name
Clinical Associates of Orlando /ID# 160889
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819-8900
Country
United States
Facility Name
Oncova Clinical Research, Inc. /ID# 160937
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
Physician Care Clin. Res., LLC /ID# 161547
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Treasure Coast Research /ID# 161824
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
Discovery Clinical Research /ID# 160891
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Precision Clinical Research /ID# 165377
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351-7311
Country
United States
Facility Name
GCP Clinical Research, LLC /ID# 164593
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-4044
Country
United States
Facility Name
University of South Florida /ID# 160960
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Jedidiah Clinical Research /ID# 167114
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Virtus Research Consultants, LLC /ID# 160855
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Comprehensive Clinical Trials LLC /ID# 161479
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Journey Medical Research Insti /ID# 160958
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Paramount Research Solutions /ID# 161557
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Agile Clinical Research Trials /ID# 160941
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328-5532
Country
United States
Facility Name
Mount Vernon Clinical Res, LLC /ID# 161491
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Women's Research Institute /ID# 160844
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Medisense Inc /ID# 161494
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30363
Country
United States
Facility Name
Duplicate_Atlanta Gynecology Research Institute /ID# 160851
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024-7159
Country
United States
Facility Name
Bingham Memorial Hospital /ID# 201130
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Leavitt Womens Healthcare /ID# 163419
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-8322
Country
United States
Facility Name
Womens Healthcare Assoc, DBA /ID# 160933
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Sonora Clinical Research /ID# 167610
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646-1144
Country
United States
Facility Name
Asr, Llc /Id# 162179
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Women's Health Practice, LLC /ID# 161553
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60605-2168
Country
United States
Facility Name
Duplicate_University of Chicago /ID# 162667
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Affinity Clinical Research /ID# 160932
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523-1245
Country
United States
Facility Name
Women's Health Advantage /ID# 161537
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Womens & Family Care, LLC dba /ID# 160890
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Bluegrass Clinical Research /ID# 163485
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291-1988
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 160838
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 160893
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Praetorian Pharmaceutical Research /ID# 161532
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Ochsner Baptist Medical Centre /ID# 161507
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Women Under Study, LLC /ID# 163990
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125-1923
Country
United States
Facility Name
Willis-Knighton Pediatric GI S /ID# 161534
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
Exordia Medical Research, Inc /ID# 160853
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02723
Country
United States
Facility Name
Great Lakes Research Group, Inc. /ID# 161511
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Wayne State University /ID# 160944
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-2013
Country
United States
Facility Name
Valley OB-Gyn Clinic - Saginaw /ID# 203579
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602-4323
Country
United States
Facility Name
Saginaw Valley Med Res Group /ID# 160840
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Quad Clinical Research, LLC /ID# 200943
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Excel Clinical Research /ID# 165588
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Office of Edmond E. Pack, MD /ID# 162604
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Private practice: Dr. Rex G. Mabey JR /ID# 160915
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Jersey Shore University Medical Center /ID# 160916
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753-4859
Country
United States
Facility Name
Lovelace Scientific Resources /ID# 163644
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Bosque Women's Care /ID# 162606
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
SUNY Downstate Medical Center /ID# 160922
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Duplicate_Northwell Health System - Manhasset /ID# 201058
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030-3816
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 161519
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Hamburg Regional Gynecology Gr /ID# 161427
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
DJL Clinical Research, PLLC /ID# 161548
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Carolina Women's Research and Wellness Center /ID# 160914
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713-7512
Country
United States
Facility Name
Unified Women's Clinical Resea /ID# 163014
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Unified Women's Clinical Resea /ID# 160957
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Inquest Center Ltd /ID# 160892
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431-2573
Country
United States
Facility Name
CTI Clinical Research Center /ID# 160942
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Univ Hosp Cleveland /ID# 160953
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Central Ohio Clinical Research /ID# 201162
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213-3399
Country
United States
Facility Name
Duplicate_Optimed Research /ID# 165600
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Hilltop Obstetrics & Gynecology /ID# 203576
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45005-5200
Country
United States
Facility Name
University of Toledo /ID# 160923
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oregon Health and Science University /ID# 161514
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
OB/GYN Associates of Erie /ID# 161541
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507-1423
Country
United States
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 160896
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania /ID# 160936
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
DUP_Thomas Jefferson University /ID# 200304
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vista Clinical Research /ID# 160946
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
VitaLink Research-Spartanburg /ID# 164592
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Chattanooga Medical Research /ID# 160885
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
WR-ClinSearch /ID# 160887
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1605
Country
United States
Facility Name
The Jackson Clinic, PA /ID# 162496
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Memphis Associates, LLC /ID# 160939
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-3895
Country
United States
Facility Name
OBGYN North /ID# 203580
City
Austin
State/Province
Texas
ZIP/Postal Code
78758-5444
Country
United States
Facility Name
Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542
City
Austin
State/Province
Texas
ZIP/Postal Code
78758-5653
Country
United States
Facility Name
Discovery Clinical Trials -HCWC /ID# 161543
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-2571
Country
United States
Facility Name
Duplicate_The University of Texas Southwestern Medical Center /ID# 161496
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8575
Country
United States
Facility Name
Baylor Scott & White /ID# 161515
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-4110
Country
United States
Facility Name
Willowbend Health and Wellness - Frisco /ID# 160954
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Facility Name
Advances in Health, Inc. /ID# 160930
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Ob/Gyn Center /ID# 165928
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Precision Research Institute, LLC /ID# 161554
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
The Woman's Hospital of Texas /ID# 160959
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Centex Studies, Inc /ID# 163858
City
Houston
State/Province
Texas
ZIP/Postal Code
77058-2705
Country
United States
Facility Name
Centex Studies, Inc. - Houston /ID# 160917
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
UAG Innovation Women Research, /ID# 167415
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
America's Adv. Wellness Center /ID# 167548
City
Houston
State/Province
Texas
ZIP/Postal Code
77080
Country
United States
Facility Name
FMC Science /ID# 160886
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
ClinRx Research, LLC /ID# 201170
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5280
Country
United States
Facility Name
Clinical Trials of Texas, Inc /ID# 161510
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
VIP Trials /ID# 161546
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Houston Ctr for Clin Research /ID# 160837
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
The Univ Texas HSC at Tyler /ID# 161533
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Center of Reproductive Medicine /ID# 162498
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Univ of Virgnia Medical center /ID# 166283
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0816
Country
United States
Facility Name
Eastern Virginia Med School /ID# 160856
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1627
Country
United States
Facility Name
Clinical Research Partners /ID# 160929
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Clinical Research Partners /ID# 160948
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Clinical Trials Virginia, Inc. /ID# 160943
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Specialists for Women /ID# 201129
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23434-8151
Country
United States
Facility Name
Tidewater Clinical Research /ID# 160949
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Henry A. Rodriguez Ginorio, MD /ID# 160861
City
San Juan
ZIP/Postal Code
00917-5022
Country
Puerto Rico
Facility Name
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862
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, analyses plans, 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
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

We'll reach out to this number within 24 hrs