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

This is a randomized, placebo controlled, multicenter study with parallel groups in order to evaluate the efficacy and safety of ulipristal acetate in female subjects with anemia associated with uterine leiomyomas. The objective of this study is to determine if daily ulipristal acetate with iron is more effective than iron alone.

• Ulipristal Acetate (Drug), also known as UPA: once daily, oral
• Iron (Drug): once daily, dried ferrous sulfate

Primary outcomes

• Change from baseline in hemoglobin levels (g/dL) [Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.]: Change from baseline in hemoglobin levels (g/dL)

Sex: Female, ages: 18 Years to 50 Years

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.

• Howard Zobrist, MS, PhD, Study director, Watson Pharmaceuticals