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NCT03271489 Clinical 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

Uterine Fibroids Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03271489
Other study ID # M16-283
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 4, 2017
Est. completion date July 11, 2024

Study information
Verified date February 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date July 11, 2024
Est. primary completion date July 11, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Elagolix Placebo
Tablets
Drug:
• E2/NETA
Capsules
Other:
• E2/NETA Placebo
Capsules
Drug:
• Elagolix
Tablets

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

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Month 60
Secondary Change in Bone Mineral Density (BMD) Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA). From Baseline through Month 60
See also
  Status Clinical Trial Phase
Completed NCT01441635 - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Phase 2
Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A