Leiomyoma, Uterine Fibroids
Conditions
Keywords
Fibroid Uterus, Leiomyoma, Uterine Fibroids, Hysterectomy, Asoprisnil
Brief summary
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.
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 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.
Interventions
DRUGAsoprisnil
Asoprisnil 10mg Tablet, oral Daily for 12 weeks
DRUGPlacebo
Placebo Tablet, oral Daily for 12 weeks
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Premenopausal women, at least 18 years of age * Diagnosis of uterine fibroid(s), confirmed by ultrasound * History of menstrual cycles between 17 and 42 days * Otherwise in good health * Scheduled for a hysterectomy at the end of the treatment period * Negative pregnancy test * Agrees to double barrier method of contraception * Pap test with no evidence of malignancy or pre-malignant changes * Endometrial biopsy with no significant histological disorder
Exclusion criteria
* Less than 3 months after having a baby or breast-feeding * Any abnormal lab or procedure result the study-doctor considers important * Severe reaction(s) to or are currently using any hormone therapy * History of cancer or alcohol or drug abuse * Diagnosis of Polycystic Ovary Syndrome * History of prolactinoma * Current use of Intrauterine Device * Significant gynecological disorder * Uterine size \> 32 weeks gestation * Current diagnosis of endometriosis * Uterine artery embolization within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index. | Final visit |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index. | Final Visit |
| Morphological changes in the endometrium, myometrium and uterine fibroids. | Final Visit |
| Change from baseline in menstrual pictogram score. | Final Month |
| Percent change from baseline in volume of the largest fibroid. | Final Visit |
| Endometrial thickness (post-treatment histologic evaluation). | Final Visit |
| Change from baseline in endometrial thickness by transvaginal ultrasound. | Final Visit |
| Percent of ovulatory subjects. | 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. | Final Visit |
Outcome results
None listed