A Long-Term Safety Study of Asoprisnil in the Treatment of Uterine Fibroids.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2, Long-Term, Open-Label, Safety Extension Study of Asoprisnil (J867) in Patients With Uterine Leiomyomata|
- 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 ]
- 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 ]
|Study Start Date:||April 2001|
|Study Completion Date:||December 2001|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156182
|Study Chair:||Medical Director||Abbott|