Long-Term Safety and Efficacy of Elagolix in Combination With Estradiol/ Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Inclusion Criteria:

- Participant is a premenopausal female at the time of Screening.

- Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound
[Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].

- Participant has Heavy Menstrual Bleeding (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.

Exclusion Criteria:

- Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS)
results that show a clinically significant gynecological disorder.

- Participant has history of osteoporosis or other metabolic bone disease.

- Participant has clinically significant abnormalities in clinical chemistry,
hematology, or urinalysis.

- Participant has a history of major depression or post-traumatic stress disorder (PTSD)
episode within 2 years of screening, OR a history of other major psychiatric disorder
at any time (e.g., schizophrenia, bipolar disorder).

- Participant is using any systemic corticosteroids for over 14 days within 3 months
prior to Screening or is likely to require treatment with systemic corticosteroids
during the course of the study. Over the counter and prescription topical, inhaled,
intranasal or intra-articular injectable (for occasional use) corticosteroids are
allowed.