Spots Global Cancer Trial Database for A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.

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Trial Identification

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

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

Study ID: NCT00156182

Conditions

Leiomyoma

Interventions

Asoprisnil

Study Description

Brief Summary: 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.

Detailed Description: 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.