A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
- Registration Number
- NCT00160459
- Lead Sponsor
- Abbott
- Brief Summary
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
- 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 safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
- Women between 18 and 49 years of age
- Diagnosis of either 1 or more uterine fibroids
- History of regular menstrual cycles of 21 to 35 days in length.
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of osteoporosis or other bone disease
- History of uterine artery embolization, cryomyolysis, or electrical myolysis
- Subject currently breast feeding
- Hemoglobin < 8 g/dL at baseline
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Asoprisnil - 4 Placebo - 1 Asoprisnil - 3 Asoprisnil -
- Primary Outcome Measures
Name Time Method Percent change from baseline in uterine volume and volume of the largest fibroid. Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6. Duration of amenorrhea Day 1 to 1st post treatment menses
- Secondary Outcome Measures
Name Time Method Change from baseline in uterine size in gestational weeks. Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6 Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume. Week 12 and final visit Percentage of days with bleeding. Day 1 through end of 1st post-treatment menses Changes in hematologic and iron parameters. Baseline to each visit Uterine fibroid symptom improvement. Baseline to each visit Response to Global Efficacy Question regarding improvement in fibroid symptoms. Week 12 and Final Visit
Related Research Topics
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