Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
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: Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively Otherwise in good health Premenopausal based on Estrogen and FSH levels Agrees to use of double barrier method of contraception Adequate endometrial biopsy with no significant histological disorder Exclusion Criteria: Any abnormal lab or procedure result(s) the study-doctor considers important Significant gynecological disorder such as confirmed endometrial polyp Hemoglobin < 8.0 g/dL History of a blood-clotting disorder Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2