A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

Inclusion Criteria:

- Pre-menopausal women, 18-50 years, inclusive.

- Cyclic abnormal uterine bleeding (heavy or prolonged).

- Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in
the first 8 days of menses.

- Minimum of one discrete leiomyoma observable by transvaginal ultrasound.

- Endometrial biopsy without evidence of malignancy or atypical or non-atypical
hyperplasia

Exclusion Criteria:

- History of uterine surgery that would interfere with the study endpoints.

- Known coagulation disorder including bleeding disorder or clotting disorder.

- History of, or current uterine, cervix, ovarian, or breast cancer.

- Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP),
or total bilirubin two times or greater than the upper limit of normal rang