Primary Outcome Measures:
- Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144 [ Time Frame: Treatment months 3 and 6 and Post-treatment months 3 and 6 ] [ Designated as safety issue: No ]
- Percentage of subjects that achieved amenorrhea. [ Time Frame: Treatment months 1-6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improvement in hematologic parameters. [ Time Frame: Treatment months 2,4,and 6 ] [ Designated as safety issue: Yes ]
- Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale [ Time Frame: Treatment Months 1-6 ] [ Designated as safety issue: No ]
- Change from baseline in uterine size in gestational weeks. [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
- Duration of amenorrhea. [ Time Frame: Start of previous study to first post-treatment menses. ] [ Designated as safety issue: No ]
- Response to global efficacy question regarding improvement of fibroid symptoms. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- Mean change from baseline for endocrine determinations. [ Time Frame: Months 2,4 and 6 ] [ Designated as safety issue: Yes ]
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.