A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
No medical therapy is currently available for the long-term treatment of uterine fibroids.
The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10
mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more
uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites
will be allowed to enter an open-label extension study
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Percent change from baseline in uterine volume and volume of the largest fibroid.
Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
United States: Food and Drug Administration