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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
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.
Time frame: From Month 0 (Baseline) to Final Month (up to Month 6)
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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
Unity Health- Searcy Medical Center /ID# 210905
Searcy, Arkansas, United States
Grossmont Ctr Clin Research /ID# 217690
La Mesa, California, United States
Women's Health Care Research Corp /ID# 211472
San Diego, California, United States
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
Fort Myers, Florida, United States
Caceres Specialized Gynecology /ID# 214956
Kissimmee, Florida, United States
LCC Medical Research Institute /ID# 213765
Miami, Florida, United States
Genoma Research Group, Inc /ID# 213771
Miami, Florida, United States
A Premier Medical Research of FL /ID# 214947
Orange City, Florida, United States
...and 38 more locations