A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
- Registration Number
- NCT03886220
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 82
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo QD Elagolix 150 mg Elagolix Elagolix 150 mg once daily (QD)
- Primary Outcome Measures
Name Time Method 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 From Month 0 (Baseline) to Final Month (up to Month 6) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
Johns Hopkins University /ID# 211135
🇺🇸Baltimore, Maryland, United States
Caceres Specialized Gynecology /ID# 214956
🇺🇸Kissimmee, Florida, United States
Georgia Research for Women /ID# 211321
🇺🇸Atlanta, Georgia, United States
Atlanta Women's Research Institute /ID# 217745
🇺🇸Atlanta, Georgia, United States
Medisense Inc /ID# 217750
🇺🇸Atlanta, Georgia, United States
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193
🇺🇸Houston, Texas, United States
Advances in Health, Inc. /ID# 215847
🇺🇸Houston, Texas, United States
Seattle Clinical Research Center /ID# 210853
🇺🇸Seattle, Washington, United States
LCC Medical Research Institute /ID# 213765
🇺🇸Miami, Florida, United States
Women's Health Care Research Corp /ID# 211472
🇺🇸San Diego, California, United States
Discovery Clinical Trials-San Antonio /ID# 214996
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas, Inc /ID# 213768
🇺🇸San Antonio, Texas, United States
Southern Clinical Research A /ID# 213732
🇺🇸Metairie, Louisiana, United States
Puerto Rico Medical Research /ID# 212841
🇵🇷Ponce, Puerto Rico
Access Clinical Trials, Inc. /ID# 215357
🇺🇸Nashville, Tennessee, United States
Comprehensive Clinical Trials LLC /ID# 217177
🇺🇸West Palm Beach, Florida, United States
NECCR Fall River LLC /ID# 215009
🇺🇸Fall River, Massachusetts, United States
Chattanooga Medical Research /ID# 215294
🇺🇸Chattanooga, Tennessee, United States
GCP Clinical Research, LLC /ID# 218742
🇺🇸Tampa, Florida, United States
Clinical Trials Management, LLC - Covington /ID# 215020
🇺🇸Covington, Louisiana, United States
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
🇺🇸Fort Myers, Florida, United States
Legacy Medical Group-Gynecologic Oncology /ID# 211016
🇺🇸Portland, Oregon, United States
Clinical Trials of SC /ID# 210204
🇺🇸Charleston, South Carolina, United States
WR-Medical Research Center of Memphis LLC /ID# 213756
🇺🇸Memphis, Tennessee, United States
A Premier Medical Research of FL /ID# 214947
🇺🇸Orange City, Florida, United States
ACCEL Research Sites /ID# 209714
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581
🇺🇸Birmingham, Alabama, United States
Grossmont Ctr Clin Research /ID# 217690
🇺🇸La Mesa, California, United States
Unity Health- Searcy Medical Center /ID# 210905
🇺🇸Searcy, Arkansas, United States
Genoma Research Group, Inc /ID# 213771
🇺🇸Miami, Florida, United States
Midtown OBGYN North /ID# 209391
🇺🇸Columbus, Georgia, United States
Women's Health of Augusta /ID# 214995
🇺🇸Augusta, Georgia, United States
Journey Medical Research Institute - Snellville /ID# 217309
🇺🇸Snellville, Georgia, United States
Affinity Clinical Research /ID# 215252
🇺🇸Oak Brook, Illinois, United States
Manhattan Medical Research /ID# 213753
🇺🇸New York, New York, United States
Clinical Research of Philadelphia, LLC /ID# 213741
🇺🇸Philadelphia, Pennsylvania, United States
Carolina Medical Trials - Winston-Salem /ID# 215027
🇺🇸Winston-Salem, North Carolina, United States
Excel Clinical Research /ID# 215936
🇺🇸Las Vegas, Nevada, United States
Upstate Clinical Research Associates /ID# 215156
🇺🇸Williamsville, New York, United States
M3 Wake Research Inc. /ID# 215166
🇺🇸Raleigh, North Carolina, United States
Reading Hospital Clinical Trials Office /ID# 213763
🇺🇸West Reading, Pennsylvania, United States
FMC Science, LLC - OB/GYN - Georgetown /ID# 211164
🇺🇸Georgetown, Texas, United States
Signature Gyn Services /ID# 213883
🇺🇸Fort Worth, Texas, United States
North Spokane Women's Health /ID# 209889
🇺🇸Spokane, Washington, United States
Houston Ctr for Clin Research /ID# 215138
🇺🇸Sugar Land, Texas, United States
Storks Research, LLC /ID# 211146
🇺🇸Sugar Land, Texas, United States
Emanuelli Research & Development Center LLC /ID# 212715
🇵🇷Arecibo, Puerto Rico
Mindful Medical Research /ID# 212496
🇵🇷San Juan, Puerto Rico