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

A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

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