Treatment of Uterine Fibroids With Asoprisnil(J867)
Leiomyoma, Menorrhagia, Metrorrhagia
About this trial
This is an interventional treatment trial for Leiomyoma focused on measuring Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage, asoprisnil
Eligibility Criteria
Inclusion Criteria: Premenopausal women History of regular menstrual cycles (21-42 days) Diagnosis of uterine fibroid(s) Abnormal vaginal bleeding associated with uterine fibroids Otherwise in good health Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails Negative pregnancy test Agrees to Double-barrier method of contraception Pap smear with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder Exclusion Criteria: Any abnormal lab or procedure result the study-doctor considers important Severe reaction(s) to or are currently using any hormone therapy History of osteoporosis or other bone disease Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months History of Polycystic Ovary Syndrome or prolactinoma MRI shows significant gynecologic disorder Uterine size > 25 weeks gestation Hemoglobin < 8 g/dL at Day -1
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
1
2
3