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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
478
Film-coated 300 mg tablets
Estradiol 1 mg/norethindrone acetate 0.5 mg capsules
Placebo capsules
Number of Participants With Adverse Events (AEs)
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.
Time frame: Baseline to 60 months
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
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.
Time frame: Baseline through Month 60
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Film-coated placebo tablets
Alabama Clinical Therapeutics /ID# 160835
Birmingham, Alabama, United States
Alabama Clinical Therapeutics /ID# 160927
Birmingham, Alabama, United States
Choice Research, LLC /ID# 161498
Dothan, Alabama, United States
Southern Women's Specialists PC /ID# 161531
Fairhope, Alabama, United States
E Squared Research /ID# 163645
Huntsville, Alabama, United States
Women's Health Alliance of Mobile /ID# 161443
Mobile, Alabama, United States
Mobile, OBGYN P.C. /ID# 161530
Mobile, Alabama, United States
Mesa Obstetricians and Gynecologists /ID# 160955
Mesa, Arizona, United States
Noble Clinical Research /ID# 166949
Tucson, Arizona, United States
Vision's Clinical Research-Tucson /ID# 161508
Tucson, Arizona, United States
...and 147 more locations