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

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Ulipristal acetate

Criteria

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.