A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
1 other identifier
interventional
82
2 countries
48
Brief Summary
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2019
Typical duration for phase_4
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2019
CompletedFirst Posted
Study publicly available on registry
March 22, 2019
CompletedStudy Start
First participant enrolled
April 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2021
CompletedResults Posted
Study results publicly available
March 31, 2022
CompletedMarch 31, 2022
March 1, 2022
2 years
March 20, 2019
March 4, 2022
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month
Responders were defined as participants meeting the following 2 conditions: * menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and * 50% or greater reduction in MBL volume from Baseline to the Final Month. Participants whose primary reason for prematurely discontinuing study drug was "lack of efficacy," or "requires surgery or invasive intervention for treatment of uterine fibroids" were considered as non-responders. MBL was measured by the alkaline hematin method.
From Month 0 (Baseline) to Final Month (up to Month 6)
Study Arms (2)
Elagolix 150 mg
EXPERIMENTALElagolix 150 mg once daily (QD)
Placebo
EXPERIMENTALPlacebo QD
Interventions
Eligibility Criteria
You may qualify if:
- Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound \[transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)\].
- Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) \> 80 mL during 1 menses in screening as measured by the alkaline hematin method.
- Participant has negative urine and/or serum pregnancy test in 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.
You may not qualify if:
- Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder.
- Participant has history of osteoporosis, osteopenia, 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (48)
ACCEL Research Sites /ID# 209714
Birmingham, Alabama, 35218, United States
University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581
Birmingham, Alabama, 35294-7333, United States
Unity Health- Searcy Medical Center /ID# 210905
Searcy, Arkansas, 72143-4802, United States
Grossmont Ctr Clin Research /ID# 217690
La Mesa, California, 91942, United States
Women's Health Care Research Corp /ID# 211472
San Diego, California, 92111-3738, United States
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
Fort Myers, Florida, 33912, United States
Caceres Specialized Gynecology /ID# 214956
Kissimmee, Florida, 34741, United States
LCC Medical Research Institute /ID# 213765
Miami, Florida, 33126, United States
Genoma Research Group, Inc /ID# 213771
Miami, Florida, 33165, United States
A Premier Medical Research of FL /ID# 214947
Orange City, Florida, 32763-2833, United States
GCP Clinical Research, LLC /ID# 218742
Tampa, Florida, 33609-3588, United States
Comprehensive Clinical Trials LLC /ID# 217177
West Palm Beach, Florida, 33409, United States
Georgia Research for Women /ID# 211321
Atlanta, Georgia, 30312-1200, United States
Atlanta Women's Research Institute /ID# 217745
Atlanta, Georgia, 30342, United States
Medisense Inc /ID# 217750
Atlanta, Georgia, 30363, United States
Women's Health of Augusta /ID# 214995
Augusta, Georgia, 30901-2775, United States
Midtown OBGYN North /ID# 209391
Columbus, Georgia, 31909-5715, United States
Journey Medical Research Institute - Snellville /ID# 217309
Snellville, Georgia, 30078-6191, United States
Affinity Clinical Research /ID# 215252
Oak Brook, Illinois, 60523-1245, United States
Clinical Trials Management, LLC - Covington /ID# 215020
Covington, Louisiana, 70433, United States
Southern Clinical Research A /ID# 213732
Metairie, Louisiana, 70001, United States
Johns Hopkins University /ID# 211135
Baltimore, Maryland, 21287, United States
NECCR Fall River LLC /ID# 215009
Fall River, Massachusetts, 02720-2972, United States
Excel Clinical Research /ID# 215936
Las Vegas, Nevada, 89109, United States
Manhattan Medical Research /ID# 213753
New York, New York, 10016-6023, United States
Upstate Clinical Research Associates /ID# 215156
Williamsville, New York, 14221-6046, United States
M3 Wake Research Inc. /ID# 215166
Raleigh, North Carolina, 27612-8106, United States
Carolina Medical Trials - Winston-Salem /ID# 215027
Winston-Salem, North Carolina, 27103-4109, United States
Legacy Medical Group-Gynecologic Oncology /ID# 211016
Portland, Oregon, 97210-2900, United States
Clinical Research of Philadelphia, LLC /ID# 213741
Philadelphia, Pennsylvania, 19114, United States
Reading Hospital Clinical Trials Office /ID# 213763
West Reading, Pennsylvania, 19611, United States
Clinical Trials of SC /ID# 210204
Charleston, South Carolina, 29406, United States
Chattanooga Medical Research /ID# 215294
Chattanooga, Tennessee, 37404, United States
WR-Medical Research Center of Memphis LLC /ID# 213756
Memphis, Tennessee, 38120-8328, United States
Access Clinical Trials, Inc. /ID# 215357
Nashville, Tennessee, 37203, United States
Signature Gyn Services /ID# 213883
Fort Worth, Texas, 76104, United States
FMC Science, LLC - OB/GYN - Georgetown /ID# 211164
Georgetown, Texas, 78626-8185, United States
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193
Houston, Texas, 77024-2515, United States
Advances in Health, Inc. /ID# 215847
Houston, Texas, 77030, United States
Clinical Trials of Texas, Inc /ID# 213768
San Antonio, Texas, 78229, United States
Discovery Clinical Trials-San Antonio /ID# 214996
San Antonio, Texas, 78258, United States
Storks Research, LLC /ID# 211146
Sugar Land, Texas, 77479-1285, United States
Houston Ctr for Clin Research /ID# 215138
Sugar Land, Texas, 77479, United States
Seattle Clinical Research Center /ID# 210853
Seattle, Washington, 98105, United States
North Spokane Women's Health /ID# 209889
Spokane, Washington, 99207, United States
Emanuelli Research & Development Center LLC /ID# 212715
Arecibo, 00612, Puerto Rico
Puerto Rico Medical Research /ID# 212841
Ponce, 00717, Puerto Rico
Mindful Medical Research /ID# 212496
San Juan, 00918-3756, Puerto Rico
Related Publications (1)
Brown E, Kroll R, Li H, Ng J, Pinsky B, Rodriguez JW, Thomas J, Snabes MC. Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2023 Nov 1;142(5):1068-1076. doi: 10.1097/AOG.0000000000005380. Epub 2023 Sep 28.
PMID: 37769311DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2019
First Posted
March 22, 2019
Study Start
April 12, 2019
Primary Completion
March 31, 2021
Study Completion
April 28, 2021
Last Updated
March 31, 2022
Results First Posted
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- 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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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 and 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.