Search / Trial NCT00001890

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

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Cellular Immunity Cytokines Estrogen Humoral Immunity Progesterone Chlamydia Pneumoniae Human Cytomegalovirus Postmenopause

Description

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.

Attachments

readout_NCT00001890_2023-11-28.pdf

4.5 MB

NCT00001890_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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