NCT00150644

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids
• Leiomyoma

Interventions

Type	Name	Description
DRUG	Asoprisnil	Asoprisnil 10mg Tablet, oral Daily for 12 weeks
DRUG	Asoprisnil	Asoprisnil 25 mg Tablet, oral Daily for 12 weeks
DRUG	Placebo	Placebo Tablet, oral Daily for 12 weeks

Timeline

• Start date: 2003-07-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2005-09-08
• Last updated: 2008-05-29