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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
10mg Tablet, oral Daily for 6 months
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
Percentage of subjects that achieved amenorrhea.
Time frame: Treatment months 1-6
Improvement in hematologic parameters.
Time frame: Treatment months 2,4,and 6
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
Change from baseline in uterine size in gestational weeks.
Time frame: Months 3 and 6
Duration of amenorrhea.
Time frame: Start of previous study to first post-treatment menses.
Response to global efficacy question regarding improvement of fibroid symptoms.
Time frame: Month 6
Mean change from baseline for endocrine determinations.
Time frame: Months 2,4 and 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.