Uterine Fibroids

Clinical Trial Title Uterine Fibroids
Trial Status Open to Enrollment
Start Date 11/07/2019
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
Notes
Principal Investigator Paul Tseng, MD
Contact Name Tammy Mayfield
Contact Phone 503-413-7945
Contact Fax 503-413-6861
Contact E-Mail tmayfiel@lhs.org