Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Inclusion Criteria: - Subject is pre-menopausal female 18 to 51 years of age at Screening.

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

- Subject has heavy uterine bleeding associated with uterine fibroids. Exclusion
Criteria: - Subject has had a myomectomy, uterine artery embolization or high
intensity focused ultrasound for fibroid destruction within 6 months prior to
Screening or endometrial ablation within 5 years prior to Screening.

- 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, schizophrenia, bipolar disorder), or neurologic diseases or any
uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any
history of attempted suicide.

- Subject has a history of clinically significant condition(s) including but not
limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes *
Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the
skin), including breast or ovarian cancer or subject has taken any systemic cancer
chemotherapy