NCT00156156

Study of Asoprisnil in the Treatment of Uterine Fibroids.

A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 149 (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 two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab 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

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

Interventions

Type	Name	Description
DRUG	Asoprisnil	Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
DRUG	Asoprisnil	Asoprisnil 25 mg Tablet, oral Daily for up to 2 years

Timeline

• Start date: 2004-11-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-09-12
• Last updated: 2008-05-28