Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections (NCT00001890) | Clinical Trial Compass
CompletedPhase 2
Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections
United States80 participantsStarted 1999-05
Plain-language summary
Hardening of the arteries (atherosclerosis) and heart disease are much more common in men than in women. However, as women grow older, especially after menopause the incidence of atherosclerosis and heart disease increases. These findings suggest that estrogen may be protective and help in preventing heart disease.
Studies of large groups of post-menopausal women suggest that hormone replacement therapy (therapy that includes estrogen) reduces the risk of heart disease. Estrogen causes favorable changes in particles that carry cholesterol in the blood stream and improves function of blood vessels. Estrogen may also stimulate the immune system's ability to fight off infections that may lead to or contribute to atherosclerosis.
Researchers believe two specific infectious agents (Chlamydia pneumoniae and human cytomegalovirus) may cause damage to the lining of blood vessels resulting in inflammation and the development of atherosclerosis.
The purpose of this study is to determine if estrogen treatment can change how the immune system responds to chronic infections, by Chlamydia pneumoniae and human cytomegalovirus, in postmenopausal women.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00001890
SponsorNational Heart, Lung, and Blood Institute (NHLBI)