Uterine Fibroids Clinical Trial
Official title:
A Phase III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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