NCT00156195

Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 523 (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 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 long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs. 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

• Leiomyoma
• Menorrhagia
• Metrorrhagia

Interventions

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

Timeline

• Start date: 2003-09-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-12
• Last updated: 2008-05-29