Safety of Treatment of Uterine Fibroids With Asoprisnil

A Phase III, 18-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 symptomatic uterine fibroids who completed the 6 month Study C02-037.

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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.

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 that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
• Otherwise good health
• Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
• Agrees to 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
• 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
• Significant gynecological disorder, such as endometrial polyp