A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety (Including Bone Density Assessment) of Two Doses of J867 Versus Placebo 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 safety and efficacy of asoprisnil 10
mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with
abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil
administration prevents surgical and/or invasive intervention in the study population.
Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive
intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to
undergo surgical and/or invasive intervention if the study medication fails, will be
enrolled in this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention.
Month 12 or Final Visit
United States: Food and Drug Administration