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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00156195
Study type Interventional
Source Abbott
Contact
Status Completed
Phase Phase 3
Start date September 2003
Completion date January 2007

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