Study of Asoprisnil in the Treatment of Uterine Fibroids.
Fibroid Uterus, Leiomyoma, Menorrhagia
About this trial
This is an interventional treatment trial for Fibroid Uterus focused on measuring Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage
Eligibility Criteria
Inclusion Criteria: Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment Otherwise in good health Premenopausal based on Estrogen and FSH levels Adequate endometrial biopsy with no significant histological disorder Agrees to use double-barrier method of contraception Exclusion Criteria: Any abnormal lab or procedure result(s) the study-doctor considers important History of a blood-clotting disorder History of osteoporosis requiring treatment Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study Hemoglobin < 8.0 g/dL Endometrial thickness ≥ 19 mm
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2