AtherosclerosisPhase 2NCT00001890
Effects of Hormone Therapy on the Immune Systems of Postmenopausal Women With Chronic Infections
A Phase 2 study testing Estrogen therapy in people with Atherosclerosis and Chlamydia Infections, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Atherosclerosis, Chlamydia Infections, Cytomegalovirus Infections
- What is being tested?
- Estrogen therapy
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 1999to Mar 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection
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.
Read more
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.
Read the 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 and/or 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.
- Conditions
- Atherosclerosis, Chlamydia Infections, Cytomegalovirus Infections, Pneumonia, Bacterial, Postmenopause
- Being tested
- Estrogen therapy
- Keywords
- Cellular Immunity, Cytokines, Estrogen, Humoral Immunity, Progesterone, Chlamydia Pneumoniae, Human Cytomegalovirus, Postmenopause
- Medical subject headings
- Atherosclerosis, Chlamydia Infections, Cytomegalovirus Infections, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrogen therapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMay 1999
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 80 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001890
- Sponsor's protocol ID
- 990100
- Other IDs
- 99-H-0100
- Status last verified
- May 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. doi: 10.1038/362801a0.
PubMed 8479518Danesh 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.
PubMed 9259669Gaydos 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.
PubMed 8613369
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT00001890
- Acronym / sponsor ID
- 990100
- Conditions
- Atherosclerosis, Chlamydia Infections, Cytomegalovirus Infections, Pneumonia, Bacterial, Postmenopause
- Keywords
- Cellular Immunity, Cytokines, Estrogen, Humoral Immunity, Progesterone, Chlamydia Pneumoniae, Human Cytomegalovirus, Postmenopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1999
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and/or 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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estrogen therapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8479518Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. doi: 10.1038/362801a0.
- Background: PubMed 9259669Danesh 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.
- Background: PubMed 8613369Gaydos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Estrogen therapy in people with Atherosclerosis and Chlamydia Infections, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001890, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008; AzTrials last refreshed its copy on 8 Nov 2026.