Spots Global Cancer Trial Database for A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

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Trial Identification

Brief Title: A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy

Official Title: 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.

Study ID: NCT00150644

Conditions

Uterine Fibroids

Leiomyoma

Interventions

Asoprisnil

Placebo

Study Description

Brief Summary: The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.

Detailed Description: 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.