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

NCT00001890 | Completed Phase 2

• 2 other identifiers: 99010099-H-0100
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis; Chlamydia Infections; Cytomegalovirus Infections; Pneumonia, Bacterial; Postmenopause

Keywords

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

Interventions

Estrogen therapy DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. doi: 10.1038/362801a0.

  PMID: 8479518 BACKGROUND

• Danesh J, Collins R, Peto R. Chronic infections and coronary heart disease: is there a link? Lancet. 1997 Aug 9;350(9075):430-6. doi: 10.1016/S0140-6736(97)03079-1.

  PMID: 9259669 BACKGROUND

• Gaydos CA, Summersgill JT, Sahney NN, Ramirez JA, Quinn TC. Replication of Chlamydia pneumoniae in vitro in human macrophages, endothelial cells, and aortic artery smooth muscle cells. Infect Immun. 1996 May;64(5):1614-20. doi: 10.1128/iai.64.5.1614-1620.1996.

  PMID: 8613369 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Chlamydia Infections; Cytomegalovirus Infections; Pneumonia, Bacterial

Interventions

Estrogen Replacement Therapy

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hormone Replacement Therapy; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: May 1, 1999
• Study Completion: March 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-05

Locations

US (1)