NCT00160381

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

A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

Detailed description

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.

Conditions

• Leiomyoma
• Menorrhagia
• Metrorrhagia

Interventions

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

Timeline

• Start date: 2002-09-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2005-09-12
• Last updated: 2008-05-29