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

July 21, 2025 updated by: AbbVie

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

This randomized multicenter 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 was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

478 participants were randomly assigned at a ratio of 2:1 to the following treatment groups:

  1. Elagolix 300 mg twice daily (BID) plus estradiol 1.0 mg/norethindrone acetate 0.5 mg (E2/NETA) once daily (QD) for 48 months, followed by 12 months PTFU
  2. Placebo for 12 months, followed by elagolix 300 mg BID plus E2/NETA QD for 36 months, followed by 12 months PTFU

This study was double-blinded during the first 12 months and open-label for the next 36 months. Participants entered up to 12 months of PTFU after completing treatment Month 48 (or at any time a participant prematurely discontinued treatment).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
478

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00917-5022
        • Henry A. Rodriguez Ginorio, MD /ID# 160861
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 160862
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235-3430
        • Alabama Clinical Therapeutics /ID# 160835
      • Birmingham, Alabama, United States, 35235-3430
        • Alabama Clinical Therapeutics /ID# 160927
      • Dothan, Alabama, United States, 36303
        • Choice Research, LLC /ID# 161498
      • Fairhope, Alabama, United States, 36532-3029
        • Southern Women's Specialists PC /ID# 161531
      • Huntsville, Alabama, United States, 35801
        • E Squared Research /ID# 163645
      • Mobile, Alabama, United States, 36604-1410
        • Women's Health Alliance of Mobile /ID# 161443
      • Mobile, Alabama, United States, 36608
        • Mobile, OBGYN P.C. /ID# 161530
    • Arizona
      • Mesa, Arizona, United States, 85209
        • Mesa Obstetricians and Gynecologists /ID# 160955
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research /ID# 166949
      • Tucson, Arizona, United States, 85712
        • Vision's Clinical Research-Tucson /ID# 161508
      • Tucson, Arizona, United States, 85745
        • Eclipse Clinical Research /ID# 161516
    • California
      • Cerritos, California, United States, 90703
        • Duplicate_Core Healthcare Group /ID# 160858
      • Encinitas, California, United States, 92024
        • Diagnamics Inc. /ID# 160950
      • Encino, California, United States, 91436
        • HRC Fertility /ID# 161493
      • Garden Grove, California, United States, 92844
        • SC Clinical Research /ID# 164395
      • Huntington Beach, California, United States, 92647
        • Duplicate_Duplicate_Marvel Clinical Research /ID# 167297
      • La Mesa, California, United States, 91942
        • Grossmont Ctr Clin Research /ID# 165120
      • Los Angeles, California, United States, 90036-4667
        • Olympia Clinical Trials /ID# 201562
      • Los Angeles, California, United States, 90057
        • National Research Institute /ID# 160952
      • Montebello, California, United States, 90640
        • Futura Research, Org /ID# 160924
      • Northridge, California, United States, 91324
        • California Medical Research Associates /ID# 161481
      • Sacramento, California, United States, 95821-2640
        • Northern California Research /ID# 161561
      • San Diego, California, United States, 92114-3643
        • Precision Research Institute - San Diego /ID# 163069
      • San Diego, California, United States, 92119
        • MD Strategies Research Centers /ID# 161544
      • Santa Ana, California, United States, 92704
        • Health care Affiliates Medical Group /ID# 163324
      • Simi Valley, California, United States, 93065
        • Alta California Medical Group /ID# 163564
      • Upland, California, United States, 91786-4027
        • Upland Clinical Research /ID# 164528
      • Valley Village, California, United States, 91607
        • Bayview Research Group LLC /ID# 161484
      • Westminster, California, United States, 92683-4567
        • Advanced RX Clinical Research /ID# 161599
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Emerson Clinical Research Inst /ID# 162181
      • Washington, District of Columbia, United States, 20036
        • James A. Simon, MD, PC /ID# 160931
    • Florida
      • Boca Raton, Florida, United States, 33433-7041
        • Women's Health Partners /ID# 203577
      • Boca Raton, Florida, United States, 33486-2269
        • David Lubetkin MD LLC /ID# 203578
      • Brandon, Florida, United States, 33510-3107
        • Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 160910
      • DeBary, Florida, United States, 32713-2260
        • Omega Research Maitland, LLC /ID# 160857
      • DeLand, Florida, United States, 32720-0920
        • Midland Florida Clinical Research Center /ID# 161487
      • Fort Lauderdale, Florida, United States, 33316
        • KO Clinical Research, LLC /ID# 160928
      • Hialeah, Florida, United States, 33016-1897
        • Sweet Hope Research Specialty Inc /ID# 163522
      • Jacksonville, Florida, United States, 32256
        • Solutions Through Adv Rch /ID# 160935
      • Lake Worth, Florida, United States, 33461
        • Altus Research, Inc /ID# 160912
      • Loxahatchee Groves, Florida, United States, 33470-4937
        • Wellington Anti-Aging Centre /ID# 203540
      • Margate, Florida, United States, 33063
        • South Florida Wellness & Clinic /ID# 161535
      • Miami, Florida, United States, 33144
        • Invictus Clinical Research Group,LLC /ID# 160925
      • Miami, Florida, United States, 33161
        • Healthcare Clinical Data, Inc /ID# 160888
      • Miami, Florida, United States, 33176-1032
        • Vista Health Research, LLC /ID# 163044
      • Miami, Florida, United States, 33172
        • Palmetto Professional Research /ID# 161442
      • Miami Lakes, Florida, United States, 33016-1501
        • Duplicate_Precision Research Organization /ID# 161522
      • Miami Springs, Florida, United States, 33166
        • Ocean Blue Medical Research Center, Inc /ID# 161549
      • Miramar, Florida, United States, 33027
        • Salom Tangir, LLC /ID# 162542
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc /ID# 163748
      • Orange City, Florida, United States, 32763-2833
        • A Premier Medical Research of FL /ID# 201882
      • Orlando, Florida, United States, 32819-8900
        • Clinical Associates of Orlando /ID# 160889
      • Saint Cloud, Florida, United States, 34769
        • Oncova Clinical Research, Inc. /ID# 160937
      • Saint Petersburg, Florida, United States, 33709-3113
        • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 160913
      • Sarasota, Florida, United States, 34239
        • Physician Care Clin. Res., LLC /ID# 161547
      • Stuart, Florida, United States, 34996
        • Treasure Coast Research /ID# 161824
      • Sunrise, Florida, United States, 33324
        • Discovery Clinical Research /ID# 160891
      • Sunrise, Florida, United States, 33351-7311
        • Precision Clinical Research /ID# 165377
      • Tampa, Florida, United States, 33609-4044
        • GCP Clinical Research, LLC /ID# 164593
      • Tampa, Florida, United States, 33617
        • Jedidiah Clinical Research /ID# 167114
      • Tampa, Florida, United States, 33613
        • University of South Florida- Neuroscience Institute /ID# 160960
      • Wellington, Florida, United States, 33414
        • Virtus Research Consultants, LLC /ID# 160855
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials LLC /ID# 161479
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Journey Medical Research Insti /ID# 160958
      • Alpharetta, Georgia, United States, 30005
        • Paramount Research Solutions /ID# 161557
      • Atlanta, Georgia, United States, 30328-5532
        • AGILE Clinical Research Trials /ID# 160941
      • Atlanta, Georgia, United States, 30328
        • Mount Vernon Clinical Res, LLC /ID# 161491
      • Atlanta, Georgia, United States, 30342
        • Atlanta Women's Research Institute /ID# 160844
      • Atlanta, Georgia, United States, 30363
        • Medisense Inc /ID# 161494
      • Suwanee, Georgia, United States, 30024-7159
        • Duplicate_Atlanta Gynecology Research Institute /ID# 160851
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital /ID# 201130
      • Idaho Falls, Idaho, United States, 83404
        • Womens Healthcare Assoc, DBA /ID# 160933
      • Idaho Falls, Idaho, United States, 83404
        • Leavitt Womens Healthcare /ID# 163419
      • Meridian, Idaho, United States, 83646-1144
        • Sonora Clinical Research /ID# 167610
      • Nampa, Idaho, United States, 83687
        • Asr, Llc /Id# 162179
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Women's Health Practice, LLC /ID# 161553
      • Chicago, Illinois, United States, 60605-2168
        • Moore for Women Healthcare and Wellness Institute, LLC /ID# 167118
      • Chicago, Illinois, United States, 60637
        • Duplicate_University of Chicago /ID# 162667
      • Oak Brook, Illinois, United States, 60523
        • Alliance for Multispecialty Research, LLC /ID# 160932
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Women's Health Advantage /ID# 161537
    • Kansas
      • Shawnee Mission, Kansas, United States, 66218
        • Womens & Family Care, LLC dba /ID# 160890
    • Kentucky
      • Louisville, Kentucky, United States, 40291-1988
        • Bluegrass Clinical Research /ID# 163485
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management, LLC - Covington /ID# 160838
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management, LLC - Covington /ID# 160893
      • Marrero, Louisiana, United States, 70072
        • Praetorian Pharmaceutical Research /ID# 161532
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist Medical Centre /ID# 161507
      • New Orleans, Louisiana, United States, 70125-1923
        • Women Under Study, LLC /ID# 163990
      • Shreveport, Louisiana, United States, 71118
        • Willis-Knighton Pediatric GI S /ID# 161534
    • Massachusetts
      • Fall River, Massachusetts, United States, 02723
        • Exordia Medical Research, Inc /ID# 160853
    • Michigan
      • Bay City, Michigan, United States, 48602
        • Duplicate_Great Lakes Research Group, Inc. /ID# 161511
      • Detroit, Michigan, United States, 48201-2013
        • Wayne State University /ID# 160944
      • Saginaw, Michigan, United States, 48602-4323
        • Valley OB-Gyn Clinic - Saginaw /ID# 203579
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Med Res Group /ID# 160840
    • Missouri
      • Saint Louis, Missouri, United States, 63109
        • Quad Clinical Research, LLC /ID# 200943
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research /ID# 165588
      • Las Vegas, Nevada, United States, 89113
        • Office of Edmond E. Pack, MD /ID# 162604
      • Las Vegas, Nevada, United States, 89128
        • Private practice: Dr. Rex G. Mabey JR /ID# 160915
    • New Jersey
      • Neptune, New Jersey, United States, 07753-4859
        • Jersey Shore University Medical Center /ID# 160916
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources /ID# 163644
      • Albuquerque, New Mexico, United States, 87109
        • Bosque Women's Care /ID# 162606
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center /ID# 160922
      • Manhasset, New York, United States, 11030-3816
        • Duplicate_Northwell Health System - Manhasset /ID# 201058
      • New York, New York, United States, 10032-3725
        • Columbia Univ Medical Center /ID# 161519
      • Orchard Park, New York, United States, 14127
        • Hamburg Regional Gynecology Gr /ID# 161427
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • DJL Clinical Research, PLLC /ID# 161548
      • Durham, North Carolina, United States, 27713-7512
        • Carolina Women's Research and Wellness Center /ID# 160914
      • Raleigh, North Carolina, United States, 27607
        • Unified Women's Clinical Resea /ID# 163014
      • Raleigh, North Carolina, United States, 27612
        • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 161490
      • Winston-Salem, North Carolina, United States, 27103
        • Unified Women's Clinical Resea /ID# 160957
    • Ohio
      • Beavercreek, Ohio, United States, 45431-2573
        • Clinical Inquest Center Ltd /ID# 160892
      • Cincinnati, Ohio, United States, 45212
        • Duplicate_CTI Clinical Research Center /ID# 160942
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp Cleveland /ID# 160953
      • Columbus, Ohio, United States, 43213-3399
        • Central Ohio Clinical Research /ID# 201162
      • Columbus, Ohio, United States, 43235
        • Duplicate_Optimed Research /ID# 165600
      • Middletown, Ohio, United States, 45005-5200
        • Hilltop Obstetrics & Gynecology /ID# 203576
      • Toledo, Ohio, United States, 43614
        • University of Toledo /ID# 160923
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Medical Research Center /ID# 161514
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507-1423
        • OB/GYN Associates of Erie /ID# 161541
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University and Milton S. Hershey Medical Center /ID# 160896
      • Philadelphia, Pennsylvania, United States, 19104-5502
        • University of Pennsylvania /ID# 160936
      • Philadelphia, Pennsylvania, United States, 19107
        • DUP_Thomas Jefferson University /ID# 200304
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Vista Clinical Research /ID# 160946
      • Spartanburg, South Carolina, United States, 29303
        • VitaLink Research-Spartanburg /ID# 164592
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421-1605
        • WR-ClinSearch /ID# 160887
      • Chattanooga, Tennessee, United States, 37404
        • Duplicate_Chattanooga Medical Research /ID# 160885
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic, PA /ID# 162496
      • Memphis, Tennessee, United States, 38119-3895
        • Research Memphis Associates, LLC /ID# 160939
    • Texas
      • Austin, Texas, United States, 78758-5444
        • OBGYN North /ID# 203580
      • Austin, Texas, United States, 78758-5653
        • Austin Area Obstetrics, Gynecology, and Fertility /Id# 203542
      • Dallas, Texas, United States, 75230-2571
        • Discovery Clinical Trials -HCWC /ID# 161543
      • Dallas, Texas, United States, 75390-8575
        • Duplicate_The University of Texas Southwestern Medical Center /ID# 161496
      • Fort Worth, Texas, United States, 76104-4110
        • Baylor Scott & White /ID# 161515
      • Frisco, Texas, United States, 75035
        • Willowbend Health and Wellness - Frisco /ID# 160954
      • Houston, Texas, United States, 77030
        • The Ob/Gyn Center /ID# 165928
      • Houston, Texas, United States, 77036
        • Precision Research Institute, LLC /ID# 161554
      • Houston, Texas, United States, 77054
        • The Woman's Hospital of Texas /ID# 160959
      • Houston, Texas, United States, 77058-2705
        • Centex Studies, Inc /ID# 163858
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc. - Houston /ID# 160917
      • Houston, Texas, United States, 77074
        • UAG Innovation Women Research, /ID# 167415
      • Houston, Texas, United States, 77080
        • America's Adv. Wellness Center /ID# 167548
      • Lampasas, Texas, United States, 76550
        • FMC Science /ID# 160886
      • Pearland, Texas, United States, 77854
        • Advances in Health, Inc. /ID# 160930
      • Plano, Texas, United States, 75024-5280
        • ClinRx Research, LLC /ID# 201170
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc /ID# 161510
      • San Antonio, Texas, United States, 78230
        • VIP Trials /ID# 161546
      • Sugar Land, Texas, United States, 77479
        • Houston Ctr for Clin Research /ID# 160837
      • Tyler, Texas, United States, 75708
        • The Univ Texas HSC at Tyler /ID# 161533
      • Webster, Texas, United States, 77598
        • Center of Reproductive Medicine /ID# 162498
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0816
        • Univ of Virgnia Medical center /ID# 166283
      • Norfolk, Virginia, United States, 23507-1627
        • Eastern Virginia Med School /ID# 160856
      • North Chesterfield, Virginia, United States, 23235
        • Clinical Research Partners /ID# 160929
      • North Chesterfield, Virginia, United States, 23235
        • Clinical Research Partners /ID# 160948
      • Richmond, Virginia, United States, 23225
        • Clinical Trials Virginia, Inc. /ID# 160943
      • Suffolk, Virginia, United States, 23434-8151
        • Specialists for Women /ID# 201129
      • Virginia Beach, Virginia, United States, 23456
        • Tidewater Clinical Research /ID# 160949

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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) or 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: E2/NETA Placebo
Placebo capsules
Other: Elagolix Placebo
Film-coated placebo tablets
Experimental: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Drug: Elagolix
Film-coated 300 mg tablets
Drug: Estradiol /norethindrone acetate (E2/NETA)
Estradiol 1 mg/norethindrone acetate 0.5 mg capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Baseline to 60 months

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.

AEs during the 12-month DB period were defined as any AEs with onset on/after first dose of study drug during the DB period and no more than 30 days after the last dose of study drug for participants who discontinued early during the DB period, or until the first dose of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported.
Baseline to 60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Time Frame: Baseline through Month 60
Percent Recovery of BMD after 6 and 12 months of post-treatment follow-up (PTFU) for Spine, Total Hip, and Femoral Neck. BMD assessments were measured by dual X-ray absorptiometry (DXA). Analysis excludes participants who switched machine manufacturer type. Percent recovery is defined as 100*(% change from Baseline to final on-treatment assessment - % change from Baseline to post-treatment visit) / (% change from Baseline to final on treatment assessment) and is defined only for subjects with BMD decrease at final on-treatment assessment.
Baseline through Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

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Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M16-283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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