Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

Inclusion Criteria:

- Subject is a pre-menopausal female ≥ 20 years of age.

- Subject has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound.

- Subject has a history of regular menstrual cycles between 24 to 35 days.

- Subject has heavy uterine bleeding associated with uterine fibroids.

Exclusion Criteria:

- Subject has had a myomectomy, uterine artery embolization, endometrial ablation or
high intensity focused ultrasound for fibroid destruction within 1 year prior to
randomization or any history of endometrial ablation.

- Subject has a history of osteoporosis or other metabolic bone disease.

- Subject shows evidence of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including
depression), or neurologic diseases or any uncontrolled medical illness such as
uncontrolled type 2 diabetes.

- Subject has a history of clinically significant condition(s) including but not
limited to:

- Endometriosis

- Epilepsy or seizures

- Type 1 diabetes

- Any cancer (except basal cell carcinoma of the skin), including breast or
ovarian cancer or subject has taken any systemic cancer chemotherapy