Clinical Trials

Inclusion Criteria:

• women ages 50 to 80

• postmenopausal as defined by: any combination of the following

  • Hormonally postmenopausal for 1 year
  • Lh greater than 15 IU/L, FSH greater than 30 IU/L
  • Total hysterectomy with oophorectomy greater than one year
  • Hysterectomy with ovaries preserved with hormone levels: Lh > 15 IU/L, FSH > 30 IU/L
• Following laboratory results with normal range, unless PI approves out of range values.
• BMI 18 to 35

Exclusion Criteria:

• structural hypothalamo-pituitary-gonadal disease
• endocrinopathy (diseases involving the following organs pituitary, thyroid, adrenals, ovaries, testes and pancreas), other than primary thyroid failure receiving replacement
• recent (within 2 weeks) estrogen, progestin, anabolic steroid or glucocorticoid use
• clinically significant ECG abnormality as determined by study team physicians
• obstructive uropathy
• history of a stroke
• history of MI or angina
• acute or chronic systemic disease
• recent transmeridian travel (traversing more than 3 time zones within 7 days of admission)
• current night shift work
• concurrent use of neuropsychiatric medications
• alcohol or drug abuse, current and within 2 years
• history of depression, psychosis, or mania
• weight gain or loss (2 kg or more in 3 weeks)
• BMI > 35 kg/m2
• anemia, hemoglobin less than 12.5 g/dl
• abnormal hepatorenal function, creatinine outside normal range, ALT greater than two times normal range
• biochemical and chemistry lab results out of physician acceptable range
• history of deep-vein thrombophlebitis
• history of Congestive Heart Failure, cardiac arrhythmias, and medications used to treat cardiac arrhythmias
• known allergy to estradiol valerate, castor oil or sesame oil
• history of smoking within the last 2 years
• untreated gall bladder disease
• lack of voluntary, written informed consent
• history of carcinoma excluding localized basal cell or squamous cell, including women with known, suspected or history of breast cancer
• not clinically postmenopausal
• women with allergies to nuts will not be enrolled in the study.