Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

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 thetest article which shows no endometrial hyperplasia;

• Is willing and able to provide written informed consent and authorization to discloseprotected 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 releasinghormone agonist in previous 6 months;

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

• Has abnormal liver functions;

• Is pregnant.