This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
433
capsules
film-coated tablets
Percentage of Participants Meeting the Criteria for Responder
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
Time frame: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Time frame: Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Time frame: Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
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Alabama Clinical Therapeutics, LLC /ID# 153217
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC /ID# 153336
Birmingham, Alabama, United States
Choice Research, LLC /ID# 153492
Dothan, Alabama, United States
Brown, Pearson, Guepet Gynecology /ID# 153278
Fairhope, Alabama, United States
University of South Alabama /ID# 153415
Mobile, Alabama, United States
Mobile, Ob-Gyn, P.C. /ID# 153442
Mobile, Alabama, United States
Mesa Obstetricians and Gynecol /ID# 153269
Mesa, Arizona, United States
Core Healthcare Group /ID# 153282
Cerritos, California, United States
Diagnamics Inc. /ID# 153347
Encinitas, California, United States
Grossmont Ctr Clin Research /ID# 153324
La Mesa, California, United States
...and 114 more locations
Percentage of Participants With Suppression of Bleeding at the Final Month
Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.
Time frame: Final Month of Treatment Period (up through Month 6)
Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period
Time frame: Month 6