A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
United States: Food and Drug Administration