Safety of Treatment of Uterine Fibroids With Asoprisnil
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, asoprisnil
Eligibility Criteria
Inclusion Criteria: Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment Otherwise good health Premenopausal based on Estrogen and Follicle Stimulating Hormone levels Agrees to 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 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 Significant gynecological disorder, such as endometrial polyp
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2