The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids.
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
33
Asoprisnil 10mg Tablet, oral Daily for 12 weeks
Asoprisnil 25 mg Tablet, oral Daily for 12 weeks
Placebo Tablet, oral Daily for 12 weeks
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
Time frame: Final visit
Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.
Time frame: Final Visit
Morphological changes in the endometrium, myometrium and uterine fibroids.
Time frame: Final Visit
Change from baseline in menstrual pictogram score.
Time frame: Final Month
Percent change from baseline in volume of the largest fibroid.
Time frame: Final Visit
Endometrial thickness (post-treatment histologic evaluation).
Time frame: Final Visit
Change from baseline in endometrial thickness by transvaginal ultrasound.
Time frame: Final Visit
Percent of ovulatory subjects.
Time frame: Final Month
Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
Time frame: Final Visit
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