 9. Patients must not be pregnant, breastfeeding or of child-bearing potential. Patients are considered not of child-bearing potential if they are surgically sterile they have undergone a total hysterectomy, bilateral tubal ligation, or bilateral oophorectomy or they are postmenopausal for greater than 12 months If patient is uncertain of amenorrhea for 12 months, a pregnancy test will be done to confirm pregnancy status. Patients in whom ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol 10 pmmL to confirm ovarian senescence 