NCT00152256

A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 18 Years – 53 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

Detailed description

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

Conditions

• Fibroid Uterus
• Leiomyoma
• Menorrhagia
• Metrorrhagia
• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Asoprisnil	Asoprisnil 10 mg Tablet, oral Daily for 6 months
DRUG	Asoprisnil	Asoprisnil 25mg Tablet, oral Daily for 6 months
DRUG	Placebo	Placebo Tablet, oral Daily for 6 months

Timeline

• Start date: 2003-09-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2005-09-09
• Last updated: 2008-05-29