NCT00156208

Safety of Treatment of Uterine Fibroids With Asoprisnil

A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.

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 long-term safety of asoprisnil 10 and 25 mg administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations. Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Conditions

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

Interventions

Type	Name	Description
DRUG	Asoprisnil	10mg Tablet, oral Daily for 18 months
DRUG	Asoprisnil	25 mg Tablet, oral Daily for 18 months

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-12
• Last updated: 2008-05-29