Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Inclusion Criteria:

• Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
• Otherwise in good health
• Premenopausal based on Estrogen and FSH levels
• Agrees to use of double barrier method of contraception
• Adequate endometrial biopsy with no significant histological disorder

Exclusion Criteria:

• Any abnormal lab or procedure result(s) the study-doctor considers important
• Significant gynecological disorder such as confirmed endometrial polyp
• Hemoglobin < 8.0 g/dL
• History of a blood-clotting disorder
• Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.