- Note: All female subjects are considered of childbearing potential unless postmenopausal or surgically sterilized and >/=3 months have passed since sterilization procedure. Postmenopausal is defined as amenorrhea for >/=12 months without an alternative medical cause. Permanent female sterilization procedures include tubal ligation, bilateral salpingectomy, hysterectomy, bilateral oophorectomy, or successful Essure placement.