Uterine Fibroids Trial Clinical Trial Title Uterine Fibroids Trial Status Open to Enrollment Start Date November 7, 2019 Location Legacy Good Samaritan Medical Center Trial Type OBGYN Specific Condition Uterine fibroids in premenopausal women Description Phase 3 Interventional Drug Trial. 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. Eligibility Criteria Ages: 18 years to 51 years Sexes: Female Criteria Inclusion Criteria: 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 each of two screening menses 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. IRB Number 10831 Principal Investigator Name Paul Tseng, MD Contact Name Tammy Mayfield Phone 503-413-7945 Contact Fax 503-413-6861 Contact E-Mail tmayfiel@lhs.org Last Updated: Thursday, November 7, 2019 03:50:38 PM