Clinical trial NCT02654054: Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Official title: A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Fibroids
Heavy Menstrual Bleeding
Keywords: Elagolix
Elagolix Sodium
Heavy Uterine Bleeding
Heavy Menstrual Bleeding
Leiomyomata
Menorrhagia
ABT-620
Elagolix + E2/NETA
Elagolix + Norethindrone Acetate
HMB
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 413
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.


Eligibility criteria: Inclusion Criteria:

* Subject is a premenopausal female at the time of Screening.
* Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
* Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
* Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
* Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.

Exclusion Criteria:

* Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
* Subject has history of osteoporosis or other metabolic bone disease.
* Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
* Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
* Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.

Primary outcomes:
measure: Percentage of Participants Meeting the Criteria for Responder
timeFrame: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Secondary outcomes:
measure: Change From Baseline in MBL Volume to the Final Month
timeFrame: Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
measure: Percentage of Participants With Suppression of Bleeding at the Final Month
timeFrame: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
measure: Change From Baseline in MBL Volume to Month 6
timeFrame: Month 0 (Baseline), Month 6
measure: Change From Baseline in MBL Volume to Month 3
timeFrame: Month 0 (Baseline), Month 3
measure: Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6
timeFrame: Month 0 (Baseline), Month 6
measure: Change From Baseline in MBL Volume to Month 1
timeFrame: Month 0 (Baseline), Month 1
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Summers, Birmingham, AL /ID# 139684
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama /ID# 148763
state: Alabama
city: Costa Mesa
country: United States
facility: WCCT Global, LLC /ID# 145666
state: California
city: Hawaiian Gardens
country: United States
facility: American Clinical Trials /ID# 147374
state: California
city: La Mesa
country: United States
facility: Grossmont Ctr Clin Research /ID# 144011
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trial Serv /ID# 152424
state: California
city: Los Angeles
country: United States
facility: National Research Institute /ID# 151629
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 144107
state: California
city: Newport Beach
country: United States
facility: Beach OBGYN Medical Group /ID# 151414
state: California
city: Westminster
country: United States
facility: Advanced RX Clinical Research /ID# 149168
state: California
city: Colorado Springs
country: United States
facility: Bluebird Clinical Trials, LLC /ID# 144843
state: Colorado
city: Greenwood Village
country: United States
facility: Advanced Women's Health Institution /ID# 144108
state: Colorado
city: Washington
country: United States
facility: Medstar Health Research Institute /ID# 145933
state: District of Columbia
city: Washington
country: United States
facility: James A. Simon, MD, PC /ID# 139675
state: District of Columbia
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC /ID# 147114
state: Florida
city: Brandon
country: United States
facility: Brandon Premier Health Care, PA /ID# 153130
state: Florida
city: Ckearwater
country: United States
facility: Florida Clin Res Group /ID# 139811
state: Florida
city: Doral
country: United States
facility: Universal Clinical Research A /ID# 139742
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates /ID# 139736
state: Florida
city: Kenneth City
country: United States
facility: Meridien Research /ID# 139663
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc /ID# 139662
state: Florida
city: Margate
country: United States
facility: South Florida Wellness & Clinic /ID# 143558
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute /ID# 143551
state: Florida
city: Miami
country: United States
facility: Healthcare Clinical Data, Inc /ID# 139650
state: Florida
city: Miami
country: United States
facility: Ocean Blue Med Research Ctr /ID# 139826
state: Florida
city: Miramar
country: United States
facility: Salom Tangir, LLC /ID# 151732
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute /ID# 143554
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando /ID# 148123
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants /ID# 139648
state: Florida
city: Panama City
country: United States
facility: Unified Womens Clin Research /ID# 145169
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials /ID# 139644
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Insti /ID# 147117
state: Georgia
city: Alpharetta
country: United States
facility: Paramount Research Solutions /ID# 139645
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials /ID# 143563
state: Georgia
city: Atlanta
country: United States
facility: Perimeter Inst Clinical Resear /ID# 148298
state: Georgia
city: Augusta
country: United States
facility: Masters of Clinical Research, Inc. /ID# 139658
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance, Inc /ID# 139655
state: Georgia
city: Boise
country: United States
facility: Boise Family Medical Center /ID# 139844
state: Idaho
city: Champaign
country: United States
facility: Women's Health Practice, LLC /ID# 143569
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials /ID# 148135
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 150980
state: Illinois
city: Avon
country: United States
facility: American Health Network of IN /ID# 139822
state: Indiana
city: Kansas City
country: United States
facility: GTC Research /ID# 141854
state: Kansas
city: Wichita
country: United States
facility: Cypress Medical Research Ctr /ID# 147116
state: Kansas
city: Owensboro
country: United States
facility: Research Integrity, LLC /ID# 139727
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 139651
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center /ID# 139740
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Insti /ID# 139836
state: Louisiana
city: Frederick
country: United States
facility: Capital Women's Care /ID# 144109
state: Maryland
city: Fall River
country: United States
facility: Genesis Clinical Research - Fall River /ID# 148449
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group,Inc /ID# 139659
state: Michigan
city: Grand Rapids
country: United States
facility: Grand Rapids Womens Health /ID# 139705
state: Michigan
city: Southfield
country: United States
facility: Wayne State University Physician Group - Southfield /ID# 139802
state: Michigan
city: Las Vegas
country: United States
facility: Office of Edmond E. Pack, MD /ID# 139792
state: Nevada
city: Las Vegas
country: United States
facility: Mabey, Las Vegas, NV /ID# 148138
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN /ID# 143567
state: New Jersey
city: Albuquerque
country: United States
facility: Bosque Women's Care /ID# 145934
state: New Mexico
city: New York
country: United States
facility: Manhattan Medical Research /ID# 144471
state: New York
city: Durham
country: United States
facility: Cwrwc /Id# 139664
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research-Greensboro /ID# 139829
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Resea /ID# 139774
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington LLC /ID# 152563
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Resea /ID# 144721
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 139820
state: Ohio
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 139741
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women /ID# 139673
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital /ID# 144430
state: Ohio
city: Toledo
country: United States
facility: University of Toledo /ID# 139787
state: Ohio
city: Portland
country: United States
facility: Legacy Medical Group-Portland /ID# 148807
state: Oregon
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center /ID# 150295
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 139733
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University /ID# 139812
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital /ID# 151429
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Svcs /ID# 139707
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 148754
state: South Carolina
city: Columbia
country: United States
facility: Vista Clinical Research /ID# 139797
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch /ID# 143538
state: Tennessee
city: Memphis
country: United States
facility: Research Memphis Associates, LLC /ID# 139674
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 139730
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center /ID# 143537
state: Texas
city: Houston
country: United States
facility: Advances in Health, Inc. /ID# 139672
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research /ID# 149630
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials-San Antonio /ID# 139776
state: Texas
city: Sugar Land
country: United States
facility: Houston Ctr for Clin Research /ID# 149149
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicin /ID# 139813
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Med School /ID# 139647
state: Virginia
city: North Chesterfield
country: United States
facility: Clinical Research Partners, LL /ID# 143999
state: Virginia
city: Richmond
country: United States
facility: Clinical Trials Virginia, Inc. /ID# 139801
state: Virginia
city: Vienna
country: United States
facility: Emerson Clinical Research /ID# 147373
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology /ID# 139768
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 148145
state: Washington
city: Milwaukee
country: United States
facility: Froedtert and Medical College /ID# 143566
state: Wisconsin
city: Halifax
country: Canada
facility: IWK Health Center /ID# 149066
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital /ID# 148695
state: Ontario
city: San Juan
country: Puerto Rico
facility: Rodriguez-Ginorio, San Juan /ID# 139847
city: San Juan
country: Puerto Rico
facility: School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139848
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.
citation: Stewart EA, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg EC, Gillispie-Bell V, Imudia AN, Liu R, Kim JH, Al-Hendy A. Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids. J Womens Health (Larchmt). 2022 May;31(5):698-705. doi: 10.1089/jwh.2021.0152. Epub 2021 Sep 28.
citation: Muneyyirci-Delale O, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg E, Gillispie V, Hurtado S, Kim JH, Wang A, Wang H, Stewart EA. Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis. F S Rep. 2021 May 26;2(3):338-346. doi: 10.1016/j.xfre.2021.05.004. eCollection 2021 Sep.
citation: Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8.
citation: Al-Hendy A, Bradley L, Owens CD, Wang H, Barnhart KT, Feinberg E, Schlaff WD, Puscheck EE, Wang A, Gillispie V, Hurtado S, Muneyyirci-Delale O, Archer DF, Carr BR, Simon JA, Stewart EA. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021 Jan;224(1):72.e1-72.e50. doi: 10.1016/j.ajog.2020.07.032. Epub 2020 Jul 20.
citation: Schlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Feinberg EC, Hurtado SM, Kim J, Liu R, Mabey RG Jr, Owens CD, Poindexter A, Puscheck EE, Rodriguez-Ginorio H, Simon JA, Soliman AM, Stewart EA, Watts NB, Muneyyirci-Delale O. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020 Jan 23;382(4):328-340. doi: 10.1056/NEJMoa1904351.