- Women must be of non-childbearing potential. Non-childbearing potential is defined as: Post-menopausal females defined as being amenorrhoeic for greater than one year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However, if indicated, this should be confirmed by estradiol and FSH levels consistent with menopause (according to local laboratory ranges) Pre-menopausal females with a documented (medical report verification) hysterectomy or tubal ligation.