Clinical trial NCT03271489: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-09-05
Enrollment: 478
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Month 60
Secondary outcomes:
measure: Change in Bone Mineral Density (BMD)
timeFrame: From Baseline through Month 60
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics /ID# 160835
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics /ID# 160927
state: Alabama
city: Dothan
country: United States
facility: Choice Research, LLC /ID# 161498
state: Alabama
city: Fairhope
country: United States
facility: Southern Women's Specialists PC /ID# 161531
state: Alabama
city: Huntsville
country: United States
facility: E Squared Research /ID# 163645
state: Alabama
city: Mobile
country: United States
facility: Women's Health Alliance of Mobile /ID# 161443
state: Alabama
city: Mobile
country: United States
facility: Mobile, OBGYN P.C. /ID# 161530
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecologists /ID# 160955
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research /ID# 166949
state: Arizona
city: Tucson
country: United States
facility: Vision's Clinical Research-Tucson /ID# 161508
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research /ID# 161516
state: Arizona
city: Cerritos
country: United States
facility: Duplicate_Core Healthcare Group /ID# 160858
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc. /ID# 160950
state: California
city: Encino
country: United States
facility: HRC Fertility /ID# 161493
state: California
city: Garden Grove
country: United States
facility: SC Clinical Research /ID# 164395
state: California
city: Huntington Beach
country: United States
facility: Duplicate_Duplicate_Marvel Clinical Research /ID# 167297
state: California
city: La Mesa
country: United States
facility: Grossmont Ctr Clin Research /ID# 165120
state: California
city: Los Angeles
country: United States
facility: Olympia Clinical Trials /ID# 201562
state: California
city: Los Angeles
country: United States
facility: National Research Institute /ID# 160952
state: California
city: Montebello
country: United States
facility: Futura Research, Org /ID# 160924
state: California
city: Northridge
country: United States
facility: California Medical Research Associates /ID# 161481
state: California
city: Sacramento
country: United States
facility: Northern California Research /ID# 161561
state: California
city: San Diego
country: United States
facility: Precision Research Institute - San Diego /ID# 163069
state: California
city: San Diego
country: United States
facility: MD Strategies Research Centers /ID# 161544
state: California
city: Santa Ana
country: United States
facility: Health care Affiliates Medical Group /ID# 163324
state: California
city: Simi Valley
country: United States
facility: Alta California Medical Group /ID# 163564
state: California
city: Upland
country: United States
facility: Upland Clinical Research /ID# 164528
state: California
city: Valley Village
country: United States
facility: Bayview Research Group LLC /ID# 161484
state: California
city: Westminster
country: United States
facility: Advanced RX Clinical Research /ID# 161599
state: California
city: Washington
country: United States
facility: Emerson Clinical Research Inst /ID# 162181
state: District of Columbia
city: Washington
country: United States
facility: James A. Simon, MD, PC /ID# 160931
state: District of Columbia
city: Boca Raton
country: United States
facility: Women's Health Partners /ID# 203577
state: Florida
city: Boca Raton
country: United States
facility: David Lubetkin MD LLC /ID# 203578
state: Florida
city: Brandon
country: United States
facility: Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910
state: Florida
city: DeBary
country: United States
facility: Omega Research Maitland, LLC /ID# 160857
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center /ID# 161487
state: Florida
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC /ID# 160928
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty Inc /ID# 163522
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Adv Rch /ID# 160935
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc /ID# 160912
state: Florida
city: Loxahatchee Groves
country: United States
facility: Wellington Anti-Aging Centre /ID# 203540
state: Florida
city: Margate
country: United States
facility: South Florida Wellness & Clinic /ID# 161535
state: Florida
city: Miami Lakes
country: United States
facility: Duplicate_Precision Research Organization /ID# 161522
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc /ID# 161549
state: Florida
city: Miami
country: United States
facility: Invictus Clinical Research Group,LLC /ID# 160925
state: Florida
city: Miami
country: United States
facility: Healthcare Clinical Data, Inc /ID# 160888
state: Florida
city: Miami
country: United States
facility: Palmetto Professional Research /ID# 161442
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC /ID# 163044
state: Florida
city: Miramar
country: United States
facility: Salom Tangir, LLC /ID# 162542
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc /ID# 163748
state: Florida
city: Orange City
country: United States
facility: A Premier Medical Research of FL /ID# 201882
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando /ID# 160889
state: Florida
city: Saint Cloud
country: United States
facility: Oncova Clinical Research, Inc. /ID# 160937
state: Florida
city: Saint Petersburg
country: United States
facility: Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clin. Res., LLC /ID# 161547
state: Florida
city: Stuart
country: United States
facility: Treasure Coast Research /ID# 161824
state: Florida
city: Sunrise
country: United States
facility: Discovery Clinical Research /ID# 160891
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research /ID# 165377
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC /ID# 164593
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Neuroscience Institute /ID# 160960
state: Florida
city: Tampa
country: United States
facility: Jedidiah Clinical Research /ID# 167114
state: Florida
city: Wellington
country: United States
facility: Virtus Research Consultants, LLC /ID# 160855
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials LLC /ID# 161479
state: Florida
city: Alpharetta
country: United States
facility: Journey Medical Research Insti /ID# 160958
state: Georgia
city: Alpharetta
country: United States
facility: Paramount Research Solutions /ID# 161557
state: Georgia
city: Atlanta
country: United States
facility: AGILE Clinical Research Trials /ID# 160941
state: Georgia
city: Atlanta
country: United States
facility: Mount Vernon Clinical Res, LLC /ID# 161491
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute /ID# 160844
state: Georgia
city: Atlanta
country: United States
facility: Medisense Inc /ID# 161494
state: Georgia
city: Suwanee
country: United States
facility: Duplicate_Atlanta Gynecology Research Institute /ID# 160851
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital /ID# 201130
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Womens Healthcare /ID# 163419
state: Idaho
city: Idaho Falls
country: United States
facility: Womens Healthcare Assoc, DBA /ID# 160933
state: Idaho
city: Meridian
country: United States
facility: Sonora Clinical Research /ID# 167610
state: Idaho
city: Nampa
country: United States
facility: Asr, Llc /Id# 162179
state: Idaho
city: Champaign
country: United States
facility: Women's Health Practice, LLC /ID# 161553
state: Illinois
city: Chicago
country: United States
facility: Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118
state: Illinois
city: Chicago
country: United States
facility: Duplicate_University of Chicago /ID# 162667
state: Illinois
city: Oak Brook
country: United States
facility: Alliance for Multispecialty Research, LLC /ID# 160932
state: Illinois
city: Fort Wayne
country: United States
facility: Women's Health Advantage /ID# 161537
state: Indiana
city: Shawnee Mission
country: United States
facility: Womens & Family Care, LLC dba /ID# 160890
state: Kansas
city: Louisville
country: United States
facility: Bluegrass Clinical Research /ID# 163485
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 160838
state: Louisiana
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 160893
state: Louisiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research /ID# 161532
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Centre /ID# 161507
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC /ID# 163990
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Pediatric GI S /ID# 161534
state: Louisiana
city: Fall River
country: United States
facility: Exordia Medical Research, Inc /ID# 160853
state: Massachusetts
city: Bay City
country: United States
facility: Duplicate_Great Lakes Research Group, Inc. /ID# 161511
state: Michigan
city: Detroit
country: United States
facility: Wayne State University /ID# 160944
state: Michigan
city: Saginaw
country: United States
facility: Valley OB-Gyn Clinic - Saginaw /ID# 203579
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Med Res Group /ID# 160840
state: Michigan
city: Saint Louis
country: United States
facility: Quad Clinical Research, LLC /ID# 200943
state: Missouri
city: Las Vegas
country: United States
facility: Excel Clinical Research /ID# 165588
state: Nevada
city: Las Vegas
country: United States
facility: Office of Edmond E. Pack, MD /ID# 162604
state: Nevada
city: Las Vegas
country: United States
facility: Private practice: Dr. Rex G. Mabey JR /ID# 160915
state: Nevada
city: Neptune
country: United States
facility: Jersey Shore University Medical Center /ID# 160916
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources /ID# 163644
state: New Mexico
city: Albuquerque
country: United States
facility: Bosque Women's Care /ID# 162606
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center /ID# 160922
state: New York
city: Manhasset
country: United States
facility: Duplicate_Northwell Health System - Manhasset /ID# 201058
state: New York
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 161519
state: New York
city: Orchard Park
country: United States
facility: Hamburg Regional Gynecology Gr /ID# 161427
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC /ID# 161548
state: North Carolina
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center /ID# 160914
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Resea /ID# 163014
state: North Carolina
city: Raleigh
country: United States
facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Resea /ID# 160957
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd /ID# 160892
state: Ohio
city: Cincinnati
country: United States
facility: Duplicate_CTI Clinical Research Center /ID# 160942
state: Ohio
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 160953
state: Ohio
city: Columbus
country: United States
facility: Central Ohio Clinical Research /ID# 201162
state: Ohio
city: Columbus
country: United States
facility: Duplicate_Optimed Research /ID# 165600
state: Ohio
city: Middletown
country: United States
facility: Hilltop Obstetrics & Gynecology /ID# 203576
state: Ohio
city: Toledo
country: United States
facility: University of Toledo /ID# 160923
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 161514
state: Oregon
city: Erie
country: United States
facility: OB/GYN Associates of Erie /ID# 161541
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 160896
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 160936
state: Pennsylvania
city: Philadelphia
country: United States
facility: DUP_Thomas Jefferson University /ID# 200304
state: Pennsylvania
city: Columbia
country: United States
facility: Vista Clinical Research /ID# 160946
state: South Carolina
city: Spartanburg
country: United States
facility: VitaLink Research-Spartanburg /ID# 164592
state: South Carolina
city: Chattanooga
country: United States
facility: Duplicate_Chattanooga Medical Research /ID# 160885
state: Tennessee
city: Chattanooga
country: United States
facility: WR-ClinSearch /ID# 160887
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic, PA /ID# 162496
state: Tennessee
city: Memphis
country: United States
facility: Research Memphis Associates, LLC /ID# 160939
state: Tennessee
city: Austin
country: United States
facility: OBGYN North /ID# 203580
state: Texas
city: Austin
country: United States
facility: Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542
state: Texas
city: Dallas
country: United States
facility: Discovery Clinical Trials -HCWC /ID# 161543
state: Texas
city: Dallas
country: United States
facility: Duplicate_The University of Texas Southwestern Medical Center /ID# 161496
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White /ID# 161515
state: Texas
city: Frisco
country: United States
facility: Willowbend Health and Wellness - Frisco /ID# 160954
state: Texas
city: Houston
country: United States
facility: The Ob/Gyn Center /ID# 165928
state: Texas
city: Houston
country: United States
facility: Precision Research Institute, LLC /ID# 161554
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas /ID# 160959
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc /ID# 163858
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc. - Houston /ID# 160917
state: Texas
city: Houston
country: United States
facility: UAG Innovation Women Research, /ID# 167415
state: Texas
city: Houston
country: United States
facility: America's Adv. Wellness Center /ID# 167548
state: Texas
city: Lampasas
country: United States
facility: FMC Science /ID# 160886
state: Texas
city: Pearland
country: United States
facility: Advances in Health, Inc. /ID# 160930
state: Texas
city: Plano
country: United States
facility: ClinRx Research, LLC /ID# 201170
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc /ID# 161510
state: Texas
city: San Antonio
country: United States
facility: VIP Trials /ID# 161546
state: Texas
city: Sugar Land
country: United States
facility: Houston Ctr for Clin Research /ID# 160837
state: Texas
city: Tyler
country: United States
facility: The Univ Texas HSC at Tyler /ID# 161533
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine /ID# 162498
state: Texas
city: Charlottesville
country: United States
facility: Univ of Virgnia Medical center /ID# 166283
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Med School /ID# 160856
state: Virginia
city: North Chesterfield
country: United States
facility: Clinical Research Partners /ID# 160929
state: Virginia
city: North Chesterfield
country: United States
facility: Clinical Research Partners /ID# 160948
state: Virginia
city: Richmond
country: United States
facility: Clinical Trials Virginia, Inc. /ID# 160943
state: Virginia
city: Suffolk
country: United States
facility: Specialists for Women /ID# 201129
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research /ID# 160949
state: Virginia
city: San Juan
country: Puerto Rico
facility: Henry A. Rodriguez Ginorio, MD /ID# 160861
city: San Juan
country: Puerto Rico
facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: