Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Dec 9, 2002

Keywords

ClinConnect Summary

The incidence of atherosclerotic cardiovascular disease in women does not approach rates seen in men until approximately a decade following menopause, suggesting that estrogen is vasculoprotective. Infectious pathogens such a Chlamydia pneumoniae (C. pneumoniae) and human cytomegalovirus (hCMV) have been implicated in the pathogenesis of atherosclerosis. Experimental studies in cultured lymphocytes and animals suggest that estrogen stimulates cell-mediated immune responsiveness, observations that are potentially relevant to the eradication of intracellular pathogens including C. pneumoniae ...

Gender

FEMALE

Eligibility criteria

• • Must be a postmenopausal woman 65 years of age or younger.
• • Time since last date of menses should be at least 12 months, with plasma estradiol less than 50 pg/ml and FSH greater than 50 pg/ml.
• • Women must be without clinical evidence of CAD as determined by history, cardiovascular physical examination, and EKG.
• • Must not have used hormone replacement therapy within past 6 months.
• • Must not have used dietary supplements and any medication (over-the-counter or prescribed) within 1 month. Acetaminophen use is allowed.
• • Must not have a history of alcoholism or binge-drinking.
• • Must not have diabetes mellitus or known abnormal glucose intolerance test.
• • Must not have a history of stroke, angina or myocardial infarction.
• • Must not have a history of deep venous thrombosis/pulmonary embolism.
• • Must not have a history of cancer (except for treated squamous cell and basal cell carcinomas).
• • Must not have evidence of liver disease (liver function enzymes greater than twice the upper limit of normal).
• • Must not have impaired renal function (creatinine greater than 1.6 mg/dl).
• • Must not have a diagnosis of an autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, thyroiditis, Raynaud's Disease).
• • Must not have a history of intermittent vaginal bleeding.
• • Must not have serum triglycerides greater than 400 mg/dL.