A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
No medical therapy is currently available for the long-term treatment of uterine fibroids.
The objective of this study is to determine the effects of asoprisnil in uterine fibroid
growth suppression. Full thickness biopsies obtained from surgical procedures will allow
the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial
angiogenesis. Various other exploratory immunohistological and biochemical specimens will
be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the
myometrium, and in uterine fibroids.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
United Kingdom: Medicines and Healthcare Products Regulatory Agency