A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata

This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.

Inclusion Criteria:

• Completed dosing and Day 84 procedures at sites in study M99-144
• No interruption of dosing
• Otherwise continued good health

Exclusion Criteria:

• Any abnormal lab result the study-doctor considers significant
• History of severe reaction to or current use of hormone therapy
• History of alcohol or drug abuse