» IF YOU NEED CARE, WE ARE HERE TO SAFELY PROVIDE IT. READ ABOUT APPOINTMENTS, SAFETY & COVID-19 TESTING.

MyHealth

Manage your account, request prescriptions, set up appointments & more.

LOG IN
Don't have an account
Contact Us

Uterine Fibroids

Trial

Clinical Trial Title

Uterine Fibroids

Trial Status

Open to Enrollment

Start Date

November 7, 2019

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