A Phase 3, Continuation Study to Evaluate the Long-Term 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 two asoprisnil
doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of
the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for
this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a
subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline
lab 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
Throughout 2 year treatment period
United States: Food and Drug Administration