Spots Global Cancer Trial Database for Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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