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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

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03271489
Collaborator
(none)
500
Enrollment
157
Locations
2
Arms
88.4
Anticipated Duration (Months)
3.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 13, 2017
Anticipated Primary Completion Date :
Aug 18, 2023
Anticipated Study Completion Date :
Jan 24, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)

Elagolix plus estradiol (E2)/norethindrone acetate (NETA)

Drug: E2/NETA
Capsules

Drug: Elagolix
Tablets
Other Names:
  • ABT-620 Elagolix sodium

    		•
    Placebo Comparator: Placebo

    Placebo

    Other: Elagolix Placebo
    Tablets

    Other: E2/NETA Placebo
    Capsules

    Outcome Measures

    Primary Outcome Measures

    1. Change in Bone Mineral Density (BMD) [From Baseline through Month 48]

      Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Clinical Therapeutics /ID# 160835 Birmingham Alabama United States 35235-3430
    2 Alabama Clinical Therapeutics /ID# 160927 Birmingham Alabama United States 35235-3430
    3 Choice Research, LLC /ID# 161498 Dothan Alabama United States 36303
    4 Southern Women's Specialists PC /ID# 161531 Fairhope Alabama United States 36532-3029
    5 E Squared Research /ID# 163645 Huntsville Alabama United States 35801
    6 Women's Health Alliance of Mobile /ID# 161443 Mobile Alabama United States 36604-1410
    7 Mobile, OBGYN P.C. /ID# 161530 Mobile Alabama United States 36608
    8 Mesa Obstetricians and Gynecologists /ID# 160955 Mesa Arizona United States 85209
    9 Noble Clinical Research /ID# 166949 Tucson Arizona United States 85704
    10 Vision's Clinical Research-Tucson /ID# 161508 Tucson Arizona United States 85712
    11 Eclipse Clinical Research /ID# 161516 Tucson Arizona United States 85745
    12 Core Healthcare Group /ID# 160858 Cerritos California United States 90703
    13 Diagnamics Inc. /ID# 160950 Encinitas California United States 92024
    14 HRC Fertility /ID# 161493 Encino California United States 91436
    15 SC Clinical Research /ID# 164395 Garden Grove California United States 92844
    16 Duplicate_Duplicate_Marvel Clinical Research /ID# 167297 Huntington Beach California United States 92647
    17 Grossmont Ctr Clin Research /ID# 165120 La Mesa California United States 91942
    18 Olympia Clinical Trials /ID# 201562 Los Angeles California United States 90036-4667
    19 National Research Institute /ID# 160952 Los Angeles California United States 90057
    20 Futura Research, Org /ID# 160924 Montebello California United States 90640
    21 California Medical Research Associates /ID# 161481 Northridge California United States 91324
    22 Northern California Research /ID# 161561 Sacramento California United States 95821-2640
    23 Precision Research Institute - San Diego /ID# 163069 San Diego California United States 92114-3643
    24 MD Strategies Research Centers /ID# 161544 San Diego California United States 92119
    25 Health care Affiliates Medical Group /ID# 163324 Santa Ana California United States 92704
    26 Alta California Medical Group /ID# 163564 Simi Valley California United States 93065
    27 Upland Clinical Research /ID# 164528 Upland California United States 91786-4027
    28 Bayview Research Group LLC /ID# 161484 Valley Village California United States 91607
    29 Advanced RX Clinical Research /ID# 161599 Westminster California United States 92683-4567
    30 Emerson Clinical Research Inst /ID# 162181 Washington District of Columbia United States 20011
    31 James A. Simon, MD, PC /ID# 160931 Washington District of Columbia United States 20036
    32 Women's Health Partners /ID# 203577 Boca Raton Florida United States 33433-7041
    33 David Lubetkin MD LLC /ID# 203578 Boca Raton Florida United States 33486-2269
    34 Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910 Brandon Florida United States 33510-3107
    35 Omega Research Maitland, LLC /ID# 160857 DeBary Florida United States 32713-2260
    36 Midland Florida Clinical Research Center /ID# 161487 DeLand Florida United States 32720-0920
    37 KO Clinical Research, LLC /ID# 160928 Fort Lauderdale Florida United States 33316
    38 Sweet Hope Research Specialty Inc /ID# 163522 Hialeah Florida United States 33016-1897
    39 Solutions Through Adv Rch /ID# 160935 Jacksonville Florida United States 32256
    40 Altus Research, Inc /ID# 160912 Lake Worth Florida United States 33461
    41 Wellington Anti-Aging Centre /ID# 203540 Loxahatchee Groves Florida United States 33470-4937
    42 South Florida Wellness & Clinic /ID# 161535 Margate Florida United States 33063
    43 Duplicate_Precision Research Organization /ID# 161522 Miami Lakes Florida United States 33016-1501
    44 Ocean Blue Medical Research Center, Inc /ID# 161549 Miami Springs Florida United States 33166
    45 Invictus Clinical Research Group,LLC /ID# 160925 Miami Florida United States 33144
    46 Healthcare Clinical Data, Inc /ID# 160888 Miami Florida United States 33161
    47 Vista Health Research, LLC /ID# 163044 Miami Florida United States 33176-1032
    48 Palmetto Professional Research /ID# 161442 Miami Florida United States 33186-1309
    49 Salom Tangir, LLC /ID# 162542 Miramar Florida United States 33027
    50 Advanced Research Institute, Inc /ID# 163748 New Port Richey Florida United States 34653
    51 A Premier Medical Research of FL /ID# 201882 Orange City Florida United States 32763-2833
    52 Clinical Associates of Orlando /ID# 160889 Orlando Florida United States 32819-8900
    53 Oncova Clinical Research, Inc. /ID# 160937 Saint Cloud Florida United States 34769
    54 Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913 Saint Petersburg Florida United States 33709-3113
    55 Physician Care Clin. Res., LLC /ID# 161547 Sarasota Florida United States 34239
    56 Treasure Coast Research /ID# 161824 Stuart Florida United States 34996
    57 Discovery Clinical Research /ID# 160891 Sunrise Florida United States 33324
    58 Precision Clinical Research /ID# 165377 Sunrise Florida United States 33351-7311
    59 GCP Clinical Research, LLC /ID# 164593 Tampa Florida United States 33609-4044
    60 University of South Florida /ID# 160960 Tampa Florida United States 33612
    61 Jedidiah Clinical Research /ID# 167114 Tampa Florida United States 33617
    62 Virtus Research Consultants, LLC /ID# 160855 Wellington Florida United States 33414
    63 Comprehensive Clinical Trials LLC /ID# 161479 West Palm Beach Florida United States 33409
    64 Journey Medical Research Insti /ID# 160958 Alpharetta Georgia United States 30005
    65 Paramount Research Solutions /ID# 161557 Alpharetta Georgia United States 30005
    66 Agile Clinical Research Trials /ID# 160941 Atlanta Georgia United States 30328-5532
    67 Mount Vernon Clinical Res, LLC /ID# 161491 Atlanta Georgia United States 30328
    68 Atlanta Women's Research Institute /ID# 160844 Atlanta Georgia United States 30342
    69 Medisense Inc /ID# 161494 Atlanta Georgia United States 30363
    70 Duplicate_Atlanta Gynecology Research Institute /ID# 160851 Suwanee Georgia United States 30024-7159
    71 Bingham Memorial Hospital /ID# 201130 Blackfoot Idaho United States 83221
    72 Leavitt Womens Healthcare /ID# 163419 Idaho Falls Idaho United States 83404-8322
    73 Womens Healthcare Assoc, DBA /ID# 160933 Idaho Falls Idaho United States 83404
    74 Sonora Clinical Research /ID# 167610 Meridian Idaho United States 83646-1144
    75 Asr, Llc /Id# 162179 Nampa Idaho United States 83687
    76 Women's Health Practice, LLC /ID# 161553 Champaign Illinois United States 61820
    77 Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118 Chicago Illinois United States 60605-2168
    78 Duplicate_University of Chicago /ID# 162667 Chicago Illinois United States 60637
    79 Affinity Clinical Research /ID# 160932 Oak Brook Illinois United States 60523-1245
    80 Women's Health Advantage /ID# 161537 Fort Wayne Indiana United States 46825
    81 Womens & Family Care, LLC dba /ID# 160890 Shawnee Mission Kansas United States 66218
    82 Bluegrass Clinical Research /ID# 163485 Louisville Kentucky United States 40291-1988
    83 Clinical Trials Management, LLC - Covington /ID# 160838 Covington Louisiana United States 70433
    84 Clinical Trials Management, LLC - Covington /ID# 160893 Covington Louisiana United States 70433
    85 Praetorian Pharmaceutical Research /ID# 161532 Marrero Louisiana United States 70072
    86 Ochsner Baptist Medical Centre /ID# 161507 New Orleans Louisiana United States 70115
    87 Women Under Study, LLC /ID# 163990 New Orleans Louisiana United States 70125-1923
    88 Willis-Knighton Pediatric GI S /ID# 161534 Shreveport Louisiana United States 71118
    89 Exordia Medical Research, Inc /ID# 160853 Fall River Massachusetts United States 02723
    90 Great Lakes Research Group, Inc. /ID# 161511 Bay City Michigan United States 48602
    91 Wayne State University /ID# 160944 Detroit Michigan United States 48201-2013
    92 Valley OB-Gyn Clinic - Saginaw /ID# 203579 Saginaw Michigan United States 48602-4323
    93 Saginaw Valley Med Res Group /ID# 160840 Saginaw Michigan United States 48604
    94 Quad Clinical Research, LLC /ID# 200943 Saint Louis Missouri United States 63109
    95 Excel Clinical Research /ID# 165588 Las Vegas Nevada United States 89109
    96 Office of Edmond E. Pack, MD /ID# 162604 Las Vegas Nevada United States 89113
    97 Private practice: Dr. Rex G. Mabey JR /ID# 160915 Las Vegas Nevada United States 89128
    98 Jersey Shore University Medical Center /ID# 160916 Neptune New Jersey United States 07753-4859
    99 Lovelace Scientific Resources /ID# 163644 Albuquerque New Mexico United States 87108
    100 Bosque Women's Care /ID# 162606 Albuquerque New Mexico United States 87109
    101 SUNY Downstate Medical Center /ID# 160922 Brooklyn New York United States 11203
    102 Duplicate_Northwell Health System - Manhasset /ID# 201058 Manhasset New York United States 11030-3816
    103 Columbia Univ Medical Center /ID# 161519 New York New York United States 10032-3725
    104 Hamburg Regional Gynecology Gr /ID# 161427 Orchard Park New York United States 14127
    105 DJL Clinical Research, PLLC /ID# 161548 Charlotte North Carolina United States 28210-8508
    106 Carolina Women's Research and Wellness Center /ID# 160914 Durham North Carolina United States 27713-7512
    107 Unified Women's Clinical Resea /ID# 163014 Raleigh North Carolina United States 27607
    108 Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490 Raleigh North Carolina United States 27612
    109 Unified Women's Clinical Resea /ID# 160957 Winston-Salem North Carolina United States 27103
    110 Clinical Inquest Center Ltd /ID# 160892 Beavercreek Ohio United States 45431-2573
    111 CTI Clinical Research Center /ID# 160942 Cincinnati Ohio United States 45212
    112 Univ Hosp Cleveland /ID# 160953 Cleveland Ohio United States 44106
    113 Central Ohio Clinical Research /ID# 201162 Columbus Ohio United States 43213-3399
    114 Duplicate_Optimed Research /ID# 165600 Columbus Ohio United States 43235
    115 Hilltop Obstetrics & Gynecology /ID# 203576 Middletown Ohio United States 45005-5200
    116 University of Toledo /ID# 160923 Toledo Ohio United States 43614
    117 Oregon Health and Science University /ID# 161514 Portland Oregon United States 97239
    118 OB/GYN Associates of Erie /ID# 161541 Erie Pennsylvania United States 16507-1423
    119 Penn State University and Milton S. Hershey Medical Center /ID# 160896 Hershey Pennsylvania United States 17033
    120 University of Pennsylvania /ID# 160936 Philadelphia Pennsylvania United States 19104-5502
    121 DUP_Thomas Jefferson University /ID# 200304 Philadelphia Pennsylvania United States 19107
    122 Vista Clinical Research /ID# 160946 Columbia South Carolina United States 29201
    123 VitaLink Research-Spartanburg /ID# 164592 Spartanburg South Carolina United States 29303
    124 Chattanooga Medical Research /ID# 160885 Chattanooga Tennessee United States 37404
    125 WR-ClinSearch /ID# 160887 Chattanooga Tennessee United States 37421-1605
    126 The Jackson Clinic, PA /ID# 162496 Jackson Tennessee United States 38305
    127 Research Memphis Associates, LLC /ID# 160939 Memphis Tennessee United States 38119-3895
    128 OBGYN North /ID# 203580 Austin Texas United States 78758-5444
    129 Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542 Austin Texas United States 78758-5653
    130 Texas Health Presbyterian Hosp /ID# 161543 Dallas Texas United States 75231
    131 The University of Texas Southwestern Medical Center /ID# 161496 Dallas Texas United States 75390-8575
    132 Texas Health Care, PLLC /ID# 161515 Fort Worth Texas United States 76104
    133 Willowbend Health and Wellness - Frisco /ID# 160954 Frisco Texas United States 75035
    134 Advances in Health, Inc. /ID# 160930 Houston Texas United States 77030
    135 The Ob/Gyn Center /ID# 165928 Houston Texas United States 77030
    136 Precision Research Institute, LLC /ID# 161554 Houston Texas United States 77036
    137 The Woman's Hospital of Texas /ID# 160959 Houston Texas United States 77054
    138 Centex Studies, Inc /ID# 163858 Houston Texas United States 77058-2705
    139 Centex Studies, Inc. - Houston /ID# 160917 Houston Texas United States 77058
    140 UAG Innovation Women Research, /ID# 167415 Houston Texas United States 77074
    141 America's Adv. Wellness Center /ID# 167548 Houston Texas United States 77080
    142 FMC Science /ID# 160886 Lampasas Texas United States 76550
    143 ClinRx Research, LLC /ID# 201170 Plano Texas United States 75024-5280
    144 Clinical Trials of Texas, Inc /ID# 161510 San Antonio Texas United States 78229
    145 VIP Trials /ID# 161546 San Antonio Texas United States 78230
    146 Houston Ctr for Clin Research /ID# 160837 Sugar Land Texas United States 77479
    147 The Univ Texas HSC at Tyler /ID# 161533 Tyler Texas United States 75708
    148 Center of Reproductive Medicine /ID# 162498 Webster Texas United States 77598
    149 Univ of Virgnia Medical center /ID# 166283 Charlottesville Virginia United States 22908-0816
    150 Eastern Virginia Med School /ID# 160856 Norfolk Virginia United States 23507-1627
    151 Clinical Research Partners, LL /ID# 160929 North Chesterfield Virginia United States 23235
    152 Clinical Research Partners, LL /ID# 160948 North Chesterfield Virginia United States 23235
    153 Clinical Trials Virginia, Inc. /ID# 160943 Richmond Virginia United States 23225
    154 Specialists for Women /ID# 201129 Suffolk Virginia United States 23434-8151
    155 Tidewater Clinical Research /ID# 160949 Virginia Beach Virginia United States 23456
    156 Henry A. Rodriguez Ginorio, MD /ID# 160861 San Juan Puerto Rico 00917-5022
    157 School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862 San Juan Puerto Rico 00935

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03271489
    Other Study ID Numbers:
    • M16-283
    First Posted:
    Sep 5, 2017
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Elagolix Sodium
    Heavy Menstrual Bleeding (HMB)
    Heavy Uterine Bleeding
    Leiomyomata
    Menorrhagia
    Elagolix + Norethindrone Acetate
    Elagolix + E2/NETA
    Elagolix
    Safety
    Efficacy
    ABT-620
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Menorrhagia
    Hemorrhage

    Study Results

    No Results Posted as of Feb 3, 2022