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
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03271489 |
|
Recruitment Status :
Active, not recruiting
First Posted : September 5, 2017
Last Update Posted : February 16, 2023
|
Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|---|
| Heavy Menstrual Bleeding Uterine Fibroids | Other: Elagolix Placebo Drug: E2/NETA Other: E2/NETA Placebo Drug: Elagolix | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 : | September 13, 2017 |
| Estimated Primary Completion Date : | November 27, 2023 |
| Estimated Study Completion Date : | July 2, 2024 |
Resource links provided by the National Library of Medicine
| 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 Name: ABT-620 Elagolix sodium |
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Placebo Comparator: Placebo
Placebo
|
Other: Elagolix Placebo
Tablets Other: E2/NETA Placebo Capsules |
Primary Outcome Measures :
- Change in Bone Mineral Density (BMD) [ Time Frame: From Baseline through Month 48 ]Bone mineral density (BMD) is measured by dual X-ray absorptiometry (DXA).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271489
Locations
Hide 157 study locations
| United States, Alabama | |
| Alabama Clinical Therapeutics /ID# 160835 | |
| Birmingham, Alabama, United States, 35235-3430 | |
| Alabama Clinical Therapeutics /ID# 160927 | |
| Birmingham, Alabama, United States, 35235-3430 | |
| Choice Research, LLC /ID# 161498 | |
| Dothan, Alabama, United States, 36303 | |
| Southern Women's Specialists PC /ID# 161531 | |
| Fairhope, Alabama, United States, 36532-3029 | |
| E Squared Research /ID# 163645 | |
| Huntsville, Alabama, United States, 35801 | |
| Women's Health Alliance of Mobile /ID# 161443 | |
| Mobile, Alabama, United States, 36604-1410 | |
| Mobile, OBGYN P.C. /ID# 161530 | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Mesa Obstetricians and Gynecologists /ID# 160955 | |
| Mesa, Arizona, United States, 85209 | |
| Noble Clinical Research /ID# 166949 | |
| Tucson, Arizona, United States, 85704 | |
| Vision's Clinical Research-Tucson /ID# 161508 | |
| Tucson, Arizona, United States, 85712 | |
| Eclipse Clinical Research /ID# 161516 | |
| Tucson, Arizona, United States, 85745 | |
| United States, California | |
| Core Healthcare Group /ID# 160858 | |
| Cerritos, California, United States, 90703 | |
| Diagnamics Inc. /ID# 160950 | |
| Encinitas, California, United States, 92024 | |
| HRC Fertility /ID# 161493 | |
| Encino, California, United States, 91436 | |
| SC Clinical Research /ID# 164395 | |
| Garden Grove, California, United States, 92844 | |
| Duplicate_Duplicate_Marvel Clinical Research /ID# 167297 | |
| Huntington Beach, California, United States, 92647 | |
| Grossmont Ctr Clin Research /ID# 165120 | |
| La Mesa, California, United States, 91942 | |
| Olympia Clinical Trials /ID# 201562 | |
| Los Angeles, California, United States, 90036-4667 | |
| National Research Institute /ID# 160952 | |
| Los Angeles, California, United States, 90057 | |
| Futura Research, Org /ID# 160924 | |
| Montebello, California, United States, 90640 | |
| California Medical Research Associates /ID# 161481 | |
| Northridge, California, United States, 91324 | |
| Northern California Research /ID# 161561 | |
| Sacramento, California, United States, 95821-2640 | |
| Precision Research Institute - San Diego /ID# 163069 | |
| San Diego, California, United States, 92114-3643 | |
| MD Strategies Research Centers /ID# 161544 | |
| San Diego, California, United States, 92119 | |
| Health care Affiliates Medical Group /ID# 163324 | |
| Santa Ana, California, United States, 92704 | |
| Alta California Medical Group /ID# 163564 | |
| Simi Valley, California, United States, 93065 | |
| Upland Clinical Research /ID# 164528 | |
| Upland, California, United States, 91786-4027 | |
| Bayview Research Group LLC /ID# 161484 | |
| Valley Village, California, United States, 91607 | |
| Advanced RX Clinical Research /ID# 161599 | |
| Westminster, California, United States, 92683-4567 | |
| United States, District of Columbia | |
| Emerson Clinical Research Inst /ID# 162181 | |
| Washington, District of Columbia, United States, 20011 | |
| James A. Simon, MD, PC /ID# 160931 | |
| Washington, District of Columbia, United States, 20036 | |
| United States, Florida | |
| Women's Health Partners /ID# 203577 | |
| Boca Raton, Florida, United States, 33433-7041 | |
| David Lubetkin MD LLC /ID# 203578 | |
| Boca Raton, Florida, United States, 33486-2269 | |
| Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910 | |
| Brandon, Florida, United States, 33510-3107 | |
| Omega Research Maitland, LLC /ID# 160857 | |
| DeBary, Florida, United States, 32713-2260 | |
| Midland Florida Clinical Research Center /ID# 161487 | |
| DeLand, Florida, United States, 32720-0920 | |
| KO Clinical Research, LLC /ID# 160928 | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Sweet Hope Research Specialty Inc /ID# 163522 | |
| Hialeah, Florida, United States, 33016-1897 | |
| Solutions Through Adv Rch /ID# 160935 | |
| Jacksonville, Florida, United States, 32256 | |
| Altus Research, Inc /ID# 160912 | |
| Lake Worth, Florida, United States, 33461 | |
| Wellington Anti-Aging Centre /ID# 203540 | |
| Loxahatchee Groves, Florida, United States, 33470-4937 | |
| South Florida Wellness & Clinic /ID# 161535 | |
| Margate, Florida, United States, 33063 | |
| Duplicate_Precision Research Organization /ID# 161522 | |
| Miami Lakes, Florida, United States, 33016-1501 | |
| Ocean Blue Medical Research Center, Inc /ID# 161549 | |
| Miami Springs, Florida, United States, 33166 | |
| Invictus Clinical Research Group,LLC /ID# 160925 | |
| Miami, Florida, United States, 33144 | |
| Healthcare Clinical Data, Inc /ID# 160888 | |
| Miami, Florida, United States, 33161 | |
| Palmetto Professional Research /ID# 161442 | |
| Miami, Florida, United States, 33172 | |
| Vista Health Research, LLC /ID# 163044 | |
| Miami, Florida, United States, 33176-1032 | |
| Salom Tangir, LLC /ID# 162542 | |
| Miramar, Florida, United States, 33027 | |
| Advanced Research Institute, Inc /ID# 163748 | |
| New Port Richey, Florida, United States, 34653 | |
| A Premier Medical Research of FL /ID# 201882 | |
| Orange City, Florida, United States, 32763-2833 | |
| Clinical Associates of Orlando /ID# 160889 | |
| Orlando, Florida, United States, 32819-8900 | |
| Oncova Clinical Research, Inc. /ID# 160937 | |
| Saint Cloud, Florida, United States, 34769 | |
| Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913 | |
| Saint Petersburg, Florida, United States, 33709-3113 | |
| Physician Care Clin. Res., LLC /ID# 161547 | |
| Sarasota, Florida, United States, 34239 | |
| Treasure Coast Research /ID# 161824 | |
| Stuart, Florida, United States, 34996 | |
| Discovery Clinical Research /ID# 160891 | |
| Sunrise, Florida, United States, 33324 | |
| Precision Clinical Research /ID# 165377 | |
| Sunrise, Florida, United States, 33351-7311 | |
| GCP Clinical Research, LLC /ID# 164593 | |
| Tampa, Florida, United States, 33609-4044 | |
| University of South Florida /ID# 160960 | |
| Tampa, Florida, United States, 33612 | |
| Jedidiah Clinical Research /ID# 167114 | |
| Tampa, Florida, United States, 33617 | |
| Virtus Research Consultants, LLC /ID# 160855 | |
| Wellington, Florida, United States, 33414 | |
| Comprehensive Clinical Trials LLC /ID# 161479 | |
| West Palm Beach, Florida, United States, 33409 | |
| United States, Georgia | |
| Journey Medical Research Insti /ID# 160958 | |
| Alpharetta, Georgia, United States, 30005 | |
| Paramount Research Solutions /ID# 161557 | |
| Alpharetta, Georgia, United States, 30005 | |
| Agile Clinical Research Trials /ID# 160941 | |
| Atlanta, Georgia, United States, 30328-5532 | |
| Mount Vernon Clinical Res, LLC /ID# 161491 | |
| Atlanta, Georgia, United States, 30328 | |
| Atlanta Women's Research Institute /ID# 160844 | |
| Atlanta, Georgia, United States, 30342 | |
| Medisense Inc /ID# 161494 | |
| Atlanta, Georgia, United States, 30363 | |
| Duplicate_Atlanta Gynecology Research Institute /ID# 160851 | |
| Suwanee, Georgia, United States, 30024-7159 | |
| United States, Idaho | |
| Bingham Memorial Hospital /ID# 201130 | |
| Blackfoot, Idaho, United States, 83221 | |
| Leavitt Womens Healthcare /ID# 163419 | |
| Idaho Falls, Idaho, United States, 83404-8322 | |
| Womens Healthcare Assoc, DBA /ID# 160933 | |
| Idaho Falls, Idaho, United States, 83404 | |
| Sonora Clinical Research /ID# 167610 | |
| Meridian, Idaho, United States, 83646-1144 | |
| Asr, Llc /Id# 162179 | |
| Nampa, Idaho, United States, 83687 | |
| United States, Illinois | |
| Women's Health Practice, LLC /ID# 161553 | |
| Champaign, Illinois, United States, 61820 | |
| Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118 | |
| Chicago, Illinois, United States, 60605-2168 | |
| Duplicate_University of Chicago /ID# 162667 | |
| Chicago, Illinois, United States, 60637 | |
| Affinity Clinical Research /ID# 160932 | |
| Oak Brook, Illinois, United States, 60523-1245 | |
| United States, Indiana | |
| Women's Health Advantage /ID# 161537 | |
| Fort Wayne, Indiana, United States, 46825 | |
| United States, Kansas | |
| Womens & Family Care, LLC dba /ID# 160890 | |
| Shawnee Mission, Kansas, United States, 66218 | |
| United States, Kentucky | |
| Bluegrass Clinical Research /ID# 163485 | |
| Louisville, Kentucky, United States, 40291-1988 | |
| United States, Louisiana | |
| Clinical Trials Management, LLC - Covington /ID# 160838 | |
| Covington, Louisiana, United States, 70433 | |
| Clinical Trials Management, LLC - Covington /ID# 160893 | |
| Covington, Louisiana, United States, 70433 | |
| Praetorian Pharmaceutical Research /ID# 161532 | |
| Marrero, Louisiana, United States, 70072 | |
| Ochsner Baptist Medical Centre /ID# 161507 | |
| New Orleans, Louisiana, United States, 70115 | |
| Women Under Study, LLC /ID# 163990 | |
| New Orleans, Louisiana, United States, 70125-1923 | |
| Willis-Knighton Pediatric GI S /ID# 161534 | |
| Shreveport, Louisiana, United States, 71118 | |
| United States, Massachusetts | |
| Exordia Medical Research, Inc /ID# 160853 | |
| Fall River, Massachusetts, United States, 02723 | |
| United States, Michigan | |
| Great Lakes Research Group, Inc. /ID# 161511 | |
| Bay City, Michigan, United States, 48602 | |
| Wayne State University /ID# 160944 | |
| Detroit, Michigan, United States, 48201-2013 | |
| Valley OB-Gyn Clinic - Saginaw /ID# 203579 | |
| Saginaw, Michigan, United States, 48602-4323 | |
| Saginaw Valley Med Res Group /ID# 160840 | |
| Saginaw, Michigan, United States, 48604 | |
| United States, Missouri | |
| Quad Clinical Research, LLC /ID# 200943 | |
| Saint Louis, Missouri, United States, 63109 | |
| United States, Nevada | |
| Excel Clinical Research /ID# 165588 | |
| Las Vegas, Nevada, United States, 89109 | |
| Office of Edmond E. Pack, MD /ID# 162604 | |
| Las Vegas, Nevada, United States, 89113 | |
| Private practice: Dr. Rex G. Mabey JR /ID# 160915 | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Jersey | |
| Jersey Shore University Medical Center /ID# 160916 | |
| Neptune, New Jersey, United States, 07753-4859 | |
| United States, New Mexico | |
| Lovelace Scientific Resources /ID# 163644 | |
| Albuquerque, New Mexico, United States, 87108 | |
| Bosque Women's Care /ID# 162606 | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| SUNY Downstate Medical Center /ID# 160922 | |
| Brooklyn, New York, United States, 11203 | |
| Duplicate_Northwell Health System - Manhasset /ID# 201058 | |
| Manhasset, New York, United States, 11030-3816 | |
| Columbia Univ Medical Center /ID# 161519 | |
| New York, New York, United States, 10032-3725 | |
| Hamburg Regional Gynecology Gr /ID# 161427 | |
| Orchard Park, New York, United States, 14127 | |
| United States, North Carolina | |
| DJL Clinical Research, PLLC /ID# 161548 | |
| Charlotte, North Carolina, United States, 28211 | |
| Carolina Women's Research and Wellness Center /ID# 160914 | |
| Durham, North Carolina, United States, 27713-7512 | |
| Unified Women's Clinical Resea /ID# 163014 | |
| Raleigh, North Carolina, United States, 27607 | |
| Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490 | |
| Raleigh, North Carolina, United States, 27612 | |
| Unified Women's Clinical Resea /ID# 160957 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Clinical Inquest Center Ltd /ID# 160892 | |
| Beavercreek, Ohio, United States, 45431-2573 | |
| CTI Clinical Research Center /ID# 160942 | |
| Cincinnati, Ohio, United States, 45212 | |
| Univ Hosp Cleveland /ID# 160953 | |
| Cleveland, Ohio, United States, 44106 | |
| Central Ohio Clinical Research /ID# 201162 | |
| Columbus, Ohio, United States, 43213-3399 | |
| Duplicate_Optimed Research /ID# 165600 | |
| Columbus, Ohio, United States, 43235 | |
| Hilltop Obstetrics & Gynecology /ID# 203576 | |
| Middletown, Ohio, United States, 45005-5200 | |
| University of Toledo /ID# 160923 | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oregon | |
| Oregon Health and Science University /ID# 161514 | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| OB/GYN Associates of Erie /ID# 161541 | |
| Erie, Pennsylvania, United States, 16507-1423 | |
| Penn State University and Milton S. Hershey Medical Center /ID# 160896 | |
| Hershey, Pennsylvania, United States, 17033 | |
| University of Pennsylvania /ID# 160936 | |
| Philadelphia, Pennsylvania, United States, 19104-5502 | |
| DUP_Thomas Jefferson University /ID# 200304 | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Vista Clinical Research /ID# 160946 | |
| Columbia, South Carolina, United States, 29201 | |
| VitaLink Research-Spartanburg /ID# 164592 | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Chattanooga Medical Research /ID# 160885 | |
| Chattanooga, Tennessee, United States, 37404 | |
| WR-ClinSearch /ID# 160887 | |
| Chattanooga, Tennessee, United States, 37421-1605 | |
| The Jackson Clinic, PA /ID# 162496 | |
| Jackson, Tennessee, United States, 38305 | |
| Research Memphis Associates, LLC /ID# 160939 | |
| Memphis, Tennessee, United States, 38119-3895 | |
| United States, Texas | |
| OBGYN North /ID# 203580 | |
| Austin, Texas, United States, 78758-5444 | |
| Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542 | |
| Austin, Texas, United States, 78758-5653 | |
| Discovery Clinical Trials -HCWC /ID# 161543 | |
| Dallas, Texas, United States, 75230-2571 | |
| Duplicate_The University of Texas Southwestern Medical Center /ID# 161496 | |
| Dallas, Texas, United States, 75390-8575 | |
| Baylor Scott & White /ID# 161515 | |
| Fort Worth, Texas, United States, 76104-4110 | |
| Willowbend Health and Wellness - Frisco /ID# 160954 | |
| Frisco, Texas, United States, 75035 | |
| Advances in Health, Inc. /ID# 160930 | |
| Houston, Texas, United States, 77030 | |
| The Ob/Gyn Center /ID# 165928 | |
| Houston, Texas, United States, 77030 | |
| Precision Research Institute, LLC /ID# 161554 | |
| Houston, Texas, United States, 77036 | |
| The Woman's Hospital of Texas /ID# 160959 | |
| Houston, Texas, United States, 77054 | |
| Centex Studies, Inc /ID# 163858 | |
| Houston, Texas, United States, 77058-2705 | |
| Centex Studies, Inc. - Houston /ID# 160917 | |
| Houston, Texas, United States, 77058 | |
| UAG Innovation Women Research, /ID# 167415 | |
| Houston, Texas, United States, 77074 | |
| America's Adv. Wellness Center /ID# 167548 | |
| Houston, Texas, United States, 77080 | |
| FMC Science /ID# 160886 | |
| Lampasas, Texas, United States, 76550 | |
| ClinRx Research, LLC /ID# 201170 | |
| Plano, Texas, United States, 75024-5280 | |
| Clinical Trials of Texas, Inc /ID# 161510 | |
| San Antonio, Texas, United States, 78229 | |
| VIP Trials /ID# 161546 | |
| San Antonio, Texas, United States, 78230 | |
| Houston Ctr for Clin Research /ID# 160837 | |
| Sugar Land, Texas, United States, 77479 | |
| The Univ Texas HSC at Tyler /ID# 161533 | |
| Tyler, Texas, United States, 75708 | |
| Center of Reproductive Medicine /ID# 162498 | |
| Webster, Texas, United States, 77598 | |
| United States, Virginia | |
| Univ of Virgnia Medical center /ID# 166283 | |
| Charlottesville, Virginia, United States, 22908-0816 | |
| Eastern Virginia Med School /ID# 160856 | |
| Norfolk, Virginia, United States, 23507-1627 | |
| Clinical Research Partners /ID# 160929 | |
| North Chesterfield, Virginia, United States, 23235 | |
| Clinical Research Partners /ID# 160948 | |
| North Chesterfield, Virginia, United States, 23235 | |
| Clinical Trials Virginia, Inc. /ID# 160943 | |
| Richmond, Virginia, United States, 23225 | |
| Specialists for Women /ID# 201129 | |
| Suffolk, Virginia, United States, 23434-8151 | |
| Tidewater Clinical Research /ID# 160949 | |
| Virginia Beach, Virginia, United States, 23456 | |
| Puerto Rico | |
| Henry A. Rodriguez Ginorio, MD /ID# 160861 | |
| San Juan, Puerto Rico, 00917-5022 | |
| 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 |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03271489 |
| Other Study ID Numbers: |
M16-283 |
| First Posted: | September 5, 2017 Key Record Dates |
| Last Update Posted: | February 16, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/ |
| Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ |
| URL: | https://vivli.org/ourmember/abbvie/ |
| 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 Leiomyomata Elagolix + Norethindrone Acetate Elagolix + E2/NETA Elagolix Heavy Menstrual Bleeding (HMB) |
Heavy Uterine Bleeding Menorrhagia Safety Efficacy ABT-620 |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Menorrhagia Hemorrhage Pathologic Processes Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Uterine Hemorrhage Uterine Diseases Menstruation Disturbances |