Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001890
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 systems 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
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 systems 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
Detailed 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 and hCMV The purpose of this study is to determine whether estrogen therapy augments cell-mediated immune responsiveness in estrogen-deficient postmenopausal women who have serologic evidence of chronic infection with C pneumoniae andor hCMV A comparison will be made between seropositive and seronegative women We propose that estrogen therapy will stimulate a more efficient cell-mediated response to these chronically persistent infectious intracellular pathogens resulting in eradication of these organisms that are of potential importance in atherogenesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-H-0100 | None | None | None |