NCT00160459

A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with 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 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

Conditions

• Leiomyoma

Interventions

Type	Name	Description
DRUG	Asoprisnil	5 mg Tablet, oral Daily for 12 weeks
DRUG	Asoprisnil	10 mg Tablet, oral Daily for 12 weeks
DRUG	Asoprisnil	25 mg Tablet, oral Daily for 12 weeks
DRUG	Placebo	Tablet, oral Daily for 12 weeks

Timeline

• Start date: 2000-05-01
• Primary completion: 2001-07-01
• Completion: 2001-07-01
• First posted: 2005-09-12
• Last updated: 2008-05-29