Inclusion Criteria:

- Is a pre-menopausal female, 18 - 50 years;

- Has documented leiomyoma(s);

- Has leiomyoma-related anemia;

- Has an endometrial biopsy within the screening period prior to the first dose of the
test article which shows no endometrial hyperplasia;

- Is willing and able to provide written informed consent and authorization to disclose
protected health information.

Exclusion Criteria:

- Has a history of uterine surgery that would interfere with the study;

- Has a condition requiring immediate or intermittent blood transfusions;

- Has a known coagulation disorder;

- Has a history of uterine, cervix, ovarian, or breast cancer;

- Has used a selective progesterone receptor modulator or a gonadotrophin releasing
hormone agonist in previous 6 months;

- Has received blood transfusion within 8 weeks before the screening visit;

- Has abnormal liver functions;

- Is pregnant.