Clinical trial NCT02925494: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Fibroids
Heavy Menstrual Bleeding
Keywords: Uterine Fibroids
Elagolix
Heavy Menstrual Bleeding
Elagolix Sodium
Elagolix plus Norethindrone Acetate
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 433
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 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.


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.

Primary outcomes:
measure: Percentage of Participants Meeting the Criteria for Responder
timeFrame: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)
Secondary outcomes:
measure: Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
timeFrame: 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)
measure: Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
timeFrame: 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)
measure: Percentage of Participants With Suppression of Bleeding at the Final Month
timeFrame: Final Month of Treatment Period (up through Month 6)
measure: 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
timeFrame: Month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC /ID# 153217
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC /ID# 153336
state: Alabama
city: Dothan
country: United States
facility: Choice Research, LLC /ID# 153492
state: Alabama
city: Fairhope
country: United States
facility: Brown, Pearson, Guepet Gynecology /ID# 153278
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama /ID# 153415
state: Alabama
city: Mobile
country: United States
facility: Mobile, Ob-Gyn, P.C. /ID# 153442
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecol /ID# 153269
state: Arizona
city: Cerritos
country: United States
facility: Core Healthcare Group /ID# 153282
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc. /ID# 153347
state: California
city: La Mesa
country: United States
facility: Grossmont Ctr Clin Research /ID# 153324
state: California
city: Norwalk
country: United States
facility: Futura Research, Inc. /ID# 153345
state: California
city: San Fernando
country: United States
facility: Farid Yasharpour MD Medical Co /ID# 153482
state: California
city: Greenwood Village
country: United States
facility: Advanced Women's Health Institution /ID# 153401
state: Colorado
city: Washington
country: United States
facility: Medstar Health Research Institute /ID# 153321
state: District of Columbia
city: Washington
country: United States
facility: Emerson Clinical Research Inst /ID# 162755
state: District of Columbia
city: Washington
country: United States
facility: James A. Simon, MD, PC /ID# 153323
state: District of Columbia
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC /ID# 153440
state: Florida
city: Brandon
country: United States
facility: Brandon Premier Health Care, PA /ID# 165791
state: Florida
city: Clearwater
country: United States
facility: Florida Fertility Institute /ID# 153308
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants, LLC /ID# 153381
state: Florida
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC /ID# 153198
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Assoc. /ID# 153444
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Adv Rch /ID# 153283
state: Florida
city: Kenneth City
country: United States
facility: Meridien Research /ID# 153310
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc /ID# 153307
state: Florida
city: Margate
country: United States
facility: South Florida Wellness & Clinic /ID# 153420
state: Florida
city: Miami Lakes
country: United States
facility: Precision Research Org, LLC /ID# 153276
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute /ID# 153296
state: Florida
city: Miami
country: United States
facility: Invictus Clinical Research Group,LLC /ID# 153196
state: Florida
city: Miami
country: United States
facility: Healthcare Clinical Data, Inc /ID# 153425
state: Florida
city: Miami
country: United States
facility: Ocean Blue Med Research Ctr /ID# 153225
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research /ID# 153206
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute /ID# 153413
state: Florida
city: Orlando
country: United States
facility: Clinical Associates of Orlando /ID# 153427
state: Florida
city: Panama City
country: United States
facility: Unified Womens Clin Research /ID# 153229
state: Florida
city: Plantation
country: United States
facility: All Wmns HC of West Broward /ID# 153434
state: Florida
city: Saint Cloud
country: United States
facility: Oncova Clinical Research, Inc. /ID# 153497
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clin. Res., LLC /ID# 153210
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc /Id# 153456
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 153271
state: Florida
city: Wellington
country: United States
facility: Axcess Medical Research /ID# 153500
state: Florida
city: Wellington
country: United States
facility: Virtus Research Consultant,LLC /ID# 153398
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials /ID# 153350
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Insti /ID# 153298
state: Georgia
city: Alpharetta
country: United States
facility: Paramount Research Solutions /ID# 153424
state: Georgia
city: Alpharetta
country: United States
facility: Paramount Research Solutions /ID# 160974
state: Georgia
city: Atlanta
country: United States
facility: Mount Vernon Clinical Res, LLC /ID# 153403
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Inst /ID# 153212
state: Georgia
city: Augusta
country: United States
facility: Masters of Clinical Research, Inc. /ID# 153295
state: Georgia
city: College Park
country: United States
facility: Paramount Research Solutions /ID# 153351
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance, Inc /ID# 153227
state: Georgia
city: Suwanee
country: United States
facility: Clinical Research Consultants of Atlanta /ID# 153285
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gynecology Research Institute /ID# 200074
state: Georgia
city: Meridian
country: United States
facility: Sonora Clinical Research /ID# 153231
state: Idaho
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 153417
state: Illinois
city: Louisville
country: United States
facility: Bluegrass Clinical Research /ID# 153280
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 153211
state: Louisiana
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 153439
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center /ID# 153459
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Insti /ID# 153228
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore Suburban Health /ID# 168386
state: Maryland
city: Fall River
country: United States
facility: NECCR Fall River LLC /ID# 153274
state: Massachusetts
city: Fall River
country: United States
facility: Genesis Clinical Research /ID# 153379
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group,Inc /ID# 153302
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Med Res Group /ID# 153498
state: Michigan
city: Southfield
country: United States
facility: Wayne State University Physician Group - Southfield /ID# 153418
state: Michigan
city: Las Vegas
country: United States
facility: Accent Clinical Trials /ID# 153474
state: Nevada
city: Las Vegas
country: United States
facility: Office of Edmond E. Pack, MD /ID# 153411
state: Nevada
city: Las Vegas
country: United States
facility: Mabey, Las Vegas, NV /ID# 153314
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN /ID# 153218
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center /ID# 153495
state: New Jersey
city: Albuquerque
country: United States
facility: Bosque Women's Care /ID# 153223
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center /ID# 153344
state: New York
city: New York
country: United States
facility: Manhattan Medical Research /ID# 153386
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine /ID# 153275
state: New York
city: Durham
country: United States
facility: Cwrwc /Id# 153313
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research-Greensboro /ID# 153499
state: North Carolina
city: High Point
country: United States
facility: Pinewest Ob-Gyn, Inc. /ID# 153197
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Centr /ID# 153341
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Resea /ID# 153312
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC /ID# 153402
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Resea /ID# 153297
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd /ID# 153436
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center /ID# 153201
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland /ID# 153450
state: Ohio
city: Toledo
country: United States
facility: University of Toledo /ID# 153409
state: Ohio
city: Westerville
country: United States
facility: Comprehensive Womens Care /ID# 153396
state: Ohio
city: Portland
country: United States
facility: Legacy Medical Group-Portland /ID# 168286
state: Oregon
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center /ID# 153410
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 153443
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 153203
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University /ID# 153319
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC /ID# 153279
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hosp Clncl Trials Ofc /ID# 153475
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 153325
state: South Carolina
city: Columbia
country: United States
facility: Vista Clinical Research /ID# 153399
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research /ID# 153405
state: Tennessee
city: Chattanooga
country: United States
facility: WR-ClinSearch /ID# 153404
state: Tennessee
city: Memphis
country: United States
facility: Research Memphis Associates, LLC /ID# 153322
state: Tennessee
city: Menphis
country: United States
facility: Women's Health Trials /ID# 153426
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 153441
state: Tennessee
city: Austin
country: United States
facility: Lotus Gynecology /ID# 153476
state: Texas
city: Dallas
country: United States
facility: Texas Health Presbyterian Hosp /ID# 153339
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center /ID# 153400
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White /ID# 153273
state: Texas
city: Frisco
country: United States
facility: Willowbend Health and Wellness /ID# 153458
state: Texas
city: Houston
country: United States
facility: Advances in Health, Inc. /ID# 153414
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas /ID# 153270
state: Texas
city: Lampasas
country: United States
facility: FMC Science /ID# 153289
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas,Inc. /ID# 153209
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials-San Antonio /ID# 153315
state: Texas
city: Sugar Land
country: United States
facility: Houston Ctr for Clin Research /ID# 153221
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicin /ID# 153320
state: Texas
city: Norfolk
country: United States
facility: Tidewater Physicians for Women /ID# 153432
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Med School /ID# 153380
state: Virginia
city: North Chesterfield
country: United States
facility: Clinical Research Partners, LL /ID# 153412
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC /ID# 153343
state: Virginia
city: Richmond
country: United States
facility: Clinical Trials Virginia, Inc. /ID# 153419
state: Virginia
city: Vienna
country: United States
facility: Emerson Clinical Research Inst /ID# 153416
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center /ID# 153342
state: Washington
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology /ID# 153306
state: Washington
city: Windsor
country: Canada
facility: Victory Reproductive Care /ID# 153299
state: Ontario
city: San Juan
country: Puerto Rico
facility: Rodriguez-Ginorio, San Juan /ID# 153328
city: San Juan
country: Puerto Rico
facility: School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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.
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.