Clinical trial NCT02691494: 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 (Replicate Study)
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 (HMB)
Leiomyomata
Menorrhagia
ABT-620
Elagolix + E2/NETA (Elagolix + Norethindrone acetate)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-02-25
Enrollment: 378
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: Baseline and 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: Alabama Clinical Therapeutics, LLC /ID# 152258
state: Alabama
city: Dothan
country: United States
facility: Choice Research, LLC /ID# 150988
state: Alabama
city: Fairhope
country: United States
facility: Brown, Pearson, Guepet Gynecology /ID# 151020
state: Alabama
city: Mobile
country: United States
facility: Mobile, Ob-Gyn, P.C. /ID# 144294
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecol /ID# 149139
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research-Tucs /ID# 151017
state: Arizona
city: Cerritos
country: United States
facility: Core Healthcare Group /ID# 151016
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc. /ID# 152469
state: California
city: Huntington Beach
country: United States
facility: HCP Clinical Research LLC /ID# 154434
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers /ID# 149752
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 149760
state: California
city: Norwalk
country: United States
facility: Futura Research, Inc. /ID# 149759
state: California
city: San Fernando
country: United States
facility: Farid Yasharpour MD Medical Co /ID# 149770
state: California
city: Tustin
country: United States
facility: Clinical Trial Investigators /ID# 152470
state: California
city: Valley Village
country: United States
facility: Bayview Research Group LLC /ID# 153799
state: California
city: Washington
country: United States
facility: Emerson Clinical Research Inst /ID# 152348
state: District of Columbia
city: Aventura
country: United States
facility: Ideal Clinical Research Inc. /ID# 149757
state: Florida
city: Brandon
country: United States
facility: Seffner Premier Health Care, P /ID# 167480
state: Florida
city: Clearwater
country: United States
facility: Olympian Clinical Research /ID# 149756
state: Florida
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC /ID# 144299
state: Florida
city: Gainesville
country: United States
facility: University of Florida /ID# 149751
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Adv Rch /ID# 151021
state: Florida
city: Kenneth City
country: United States
facility: Meridien Research /ID# 167100
state: Florida
city: Miami Lakes
country: United States
facility: Precision Research Org, LLC /ID# 144335
state: Florida
city: Miami
country: United States
facility: Invictus Clinical Research Group,LLC /ID# 141859
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research /ID# 149765
state: Florida
city: Plantation
country: United States
facility: All Wmns HC of West Broward /ID# 144298
state: Florida
city: Saint Cloud
country: United States
facility: Oncova Clinical Research, Inc. /ID# 149764
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clin. Res., LLC /ID# 149766
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc /Id# 144325
state: Florida
city: Stuart
country: United States
facility: Martin Health System Center /ID# 152263
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 149754
state: Florida
city: Wellington
country: United States
facility: Axcess Medical Research /ID# 149769
state: Florida
city: Wellington
country: United States
facility: Virtus Research Consultant,LLC /ID# 144296
state: Florida
city: Alpharetta
country: United States
facility: Paramount Research Solutions /ID# 149291
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials /ID# 167074
state: Georgia
city: Atlanta
country: United States
facility: Mount Vernon Clinical Res, LLC /ID# 144297
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Inst /ID# 144303
state: Georgia
city: Augusta
country: United States
facility: Masters of Clinical Research, Inc. /ID# 167400
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University /ID# 144295
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC /ID# 149144
state: Georgia
city: Smyrna
country: United States
facility: Gyn-Care, Inc. /ID# 149341
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gynecology Research Institute /ID# 151014
state: Georgia
city: Idaho Falls
country: United States
facility: Womens Healthcare Assoc, DBA /ID# 149762
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research /ID# 149767
state: Idaho
city: Chicago
country: United States
facility: University of Chicago /ID# 152257
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 167119
state: Illinois
city: Palos Heights
country: United States
facility: Center for Women's Research, Inc /ID# 144300
state: Illinois
city: Fort Wayne
country: United States
facility: Women's Health Advantage /ID# 144301
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic /ID# 150105
state: Iowa
city: Wichita
country: United States
facility: PRN Professional Research Network of Kansas, LLC /ID# 152265
state: Kansas
city: Louisville
country: United States
facility: Bluegrass Clinical Research /ID# 150103
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 144314
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC /ID# 144312
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore Suburban Health /ID# 154638
state: Maryland
city: Glen Burnie
country: United States
facility: Womens Health Center /ID# 154209
state: Maryland
city: Lutherville
country: United States
facility: Maryland Ctr for Sexual Health /ID# 149778
state: Maryland
city: Fall River
country: United States
facility: NECCR Fall River LLC /ID# 149584
state: Massachusetts
city: Saginaw
country: United States
facility: Saginaw Valley Med Res Group /ID# 149768
state: Michigan
city: Las Vegas
country: United States
facility: Accent Clinical Trials /ID# 149753
state: Nevada
city: Neptune
country: United States
facility: Jersey Shore University Medical Center /ID# 149779
state: New Jersey
city: Stratford
country: United States
facility: Rowan University SOM /ID# 152697
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center /ID# 149582
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center /ID# 144311
state: New York
city: New York
country: United States
facility: Manhattan Medical Research /ID# 167077
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine /ID# 149585
state: New York
city: Fayetteville
country: United States
facility: Duplicate_Unified Women's Clinical Research-Fayetteville /ID# 149587
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research-Greensboro /ID# 149588
state: North Carolina
city: High Point
country: United States
facility: Pinewest Ob-Gyn, Inc. /ID# 145671
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Centr /ID# 144309
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC /ID# 144307
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd /ID# 148728
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center /ID# 149761
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital /ID# 150104
state: Ohio
city: Dayton
country: United States
facility: Alpha Research Associates LLC /ID# 152471
state: Ohio
city: Westerville
country: United States
facility: Comprehensive Womens Care /ID# 144306
state: Ohio
city: Levittown
country: United States
facility: Family Medical Associates /ID# 145668
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 149586
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC /ID# 151015
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hosp Clncl Trials Ofc /ID# 149583
state: Pennsylvania
city: Bristol
country: United States
facility: Holston Medical Group /ID# 149763
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Medical Research /ID# 145667
state: Tennessee
city: Hixson
country: United States
facility: Chattanooga Women for Women /ID# 167051
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic, PA /ID# 145670
state: Tennessee
city: Memphis
country: United States
facility: The Womens Physician Group /ID# 144317
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 167333
state: Tennessee
city: Austin
country: United States
facility: Lotus Gynecology /ID# 149140
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research /ID# 149755
state: Texas
city: Dallas
country: United States
facility: Texas Health Presbyterian Hosp /ID# 149142
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine /ID# 149141
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas /ID# 144319
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc. - Houston /ID# 150106
state: Texas
city: Houston
country: United States
facility: BI Research Center /ID# 149143
state: Texas
city: Lampasas
country: United States
facility: FMC Science /ID# 151802
state: Texas
city: Plano
country: United States
facility: Willowbend Health and Wellness /ID# 144318
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas,Inc. /ID# 144322
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicin /ID# 167235
state: Texas
city: Franklin
country: United States
facility: Southampton Women's Health /ID# 152325
state: Virginia
city: Norfolk
country: United States
facility: Tidewater Physicians for Women /ID# 144321
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC /ID# 144310
state: Virginia
city: Richmond
country: United States
facility: Alliance Womens Health /ID# 152468
state: Virginia
city: Richland
country: United States
facility: Zain Research /ID# 151018
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center /ID# 149758
state: Washington
city: Sudbury
country: Canada
facility: Medicor Research Inc. /ID# 153406
state: Ontario
city: Windsor
country: Canada
facility: Victory Reproductive Care /ID# 150247
state: Ontario
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: 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.