Postmenopausal, verified by: \r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >= 1 year or\r\n* No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Post-menopausal defined as the absence of menses for at least one year (serum FSH ?20IU/L can also be measured according to local practice), OR
postmenopausal (defined as at least 1 year without menses) prior to screening or
INCLUSION - ENROLLMENT: Only postmenopausal women will be eligible. Subjects will be classified as being postmenopausal if they have had:\r\n* No spontaneous menses > 1 year, or\r\n* Bilateral surgical oophorectomy, or\r\n* No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
Postmenopausal with last natural menses > 24 months prior
Postmenopausal or premenopausal; \r\n* NOTE: Postmenopausal women, verified by: \r\n** Bilateral surgical oophorectomy, or \r\n** No spontaneous menses >= 1 year or \r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards; \r\n* Premenopausal women, verified by: \r\n** Regular menses, or \r\n** FSH and estradiol levels in premenopausal range, according to institutional standards
postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to Screening, or
Patients may be premenopausal or postmenopausal at the time of randomization; for study purposes, postmenopausal is defined as:\r\n* Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or\r\n* Age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or\r\n* Documented bilateral oophorectomy
post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
Sexually active female patients of childbearing potential and sexually active male patients must agree to use an effective method of birth control (e.g., barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 4 months after final administration of study drug. Note that sterility in female patients must be confirmed in the patients' medical records and be defined as any of the following: surgical hysterectomy with bilateral oophorectomy, bilateral tubular ligation, natural menopause with last menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with last menses >1 year ago.
Be of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile or post-hysterectomy (at least 1 month prior to Screening)
Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
Only postmenopausal women will be eligible; subjects will be classified as being postmenopausal if they have had:\r\n* Bilateral surgical oophorectomy, or\r\n* No spontaneous menses > 1 year or\r\n* No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Not of childbearing potential: postmenopausal (defined as no spontaneous menses for at least 12 consecutive months prior to Screening with follicle-stimulating hormone [FSH] > 40 IU/L for women < 55 years of age at Screening), or documented to be surgically sterile or status posthysterectomy (at least 1 month prior to Screening).
Patients must be postmenopausal women defined as: Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or Age 55 or younger with no menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Age greater than or equal to 18 with documented bilateral oophorectomy.
Postmenopausal defined as no menses for 12 or more months without an alternative medical cause OR
Post-menopausal women, as verified by:\r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >= 1 year, or\r\n* No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
Postmenopausal women; women are eligible if they are postmenopausal (older than 50 years of age with no spontaneous menses for at least 12 months; or 50 years of age or younger either with no spontaneous menses [amenorrheic] within 12 months of randomization [e.g., spontaneous or secondary to hysterectomy] and a follicle-stimulating hormone level within the postmenopausal range or with prior bilateral oophorectomy)
Premenopausal levels of estradiol, or ongoing menses
of non-childbearing potential (i.e., women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile
Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
Patient is postmenopausal or premenopausal\r\n* NOTE: postmenopausal women, verified by\r\n** Bilateral surgical oophorectomy, or\r\n** No spontaneous menses >= 1 year or\r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards or\r\n* Premenopausal women, verified by:\r\n** Regular menses or\r\n** FSH and estradiol levels in premenopausal range, according to institutional standards
Age >= 50 years and postmenopausal with no menses for at least one year prior to study enrollment
Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterile
post-menopausal (defined as at least 1 year without any menses) prior to Screening,
Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
Postmenopausal women defined by either: natural menopause with at least one year since last menses, or chemotherapy-induced menopause with at least one year since last menses and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
Eligible women are those who:\r\n* Are post-menopausal, verified by:\r\n** Post bilateral surgical oophorectomy; or\r\n** No spontaneous menses >= 1 year; or\r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Natural menopause with last menses >1 year ago
Radiation induced oophorectomy with last menses >1 year ago
Chemotherapy induced menopause with last menses >1 year ago
Postmenopausal women, defined as:\r\n* Age > 45 with no menses for at least 2 years
Menopause as defined as no menses for 1 year and/or follicle-stimulating hormone (FSH) >= 25.8 mIU/ml
confirming the subject is post menopausal, with a minimum 1 year without menses
Postmenopausal (defined as at least 1 year without any menses) prior to screening, or
Patient is postmenopausal\r\nFor study purposes, postmenopausal is defined as:\r\n* Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or\r\n* Age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g. spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or\r\n* Documented bilateral oophorectomy