Summary:
This Phase 3, randomized, double-blind, multicenter, placebo-controlled study is designed to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with E2/NETA in the management of premenopausal women with heavy menstrual bleeding associated with uterine fibroids. Approximately 400 subjects will be randomized in the study.
Qualified Participants Must:
• Have a diagnosis of uterine fibroids documented by a Pelvic Ultrasound (TAU, TVU) assessed by a central reader.
•
Not have active pelvic inflammatory disease (PID) nor surgical history of: Hysterectomy, Bilateral oophorectomy, or Bariatric surgical procedures within 6 months.
Qualified Participants May Receive:
Compensation for time and travel.
Free study medications.
Free medical evaluations and study imaging.