AtherosclerosisPhase 2/3NCT00115024
EPAT: Estrogen in the Prevention of Atherosclerosis Trial
A Phase 2/3 study testing Micronized 17B-estradiol in people with Atherosclerosis and Postmenopause, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 46 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Postmenopause
- What is being tested?
- Micronized 17B-estradiol
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1994to Nov 1998
- Phase
- Phase 2/3
- 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 46 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal female (serum estradiol less than 20 pg/ml)
- 46 to 80 years old
- Fasting LDL-C levels 130 to 210 mg/dL
- Triglyceride levels less than 400 mg/dL
- Current non-smoker
Who cannot join
- Clinical evidence of cardiovascular disease
- HDL-C level less than 30 mg/dL
- Fasting blood glucose greater than 200 mg/dL
- Previous hormonal replacement therapy (non-contraceptive) over 10 years duration and/or current use within 1 month
- Uncontrolled hypertension
- Untreated thyroid disease
Show all 12Show fewer
- Renal insufficiency
- Clinical evidence of congestive heart failure
- Life threatening disease with prognosis less than 5 years
- Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use)
- History of estrogen dependent cancer or detected at screening or any other disorder precluding use of ERT
- Hot flashes greater than 5 per day which interfere with daily activity and preclude randomization to placebo.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, 90033
About this study
Official title: Estrogen in the Prevention of Atherosclerosis Trial
The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).
Read the detailed description
The primary goal of this randomized, controlled trial is to determine if ERT stabilizes, retards, and/or reverses the progression of atherosclerosis in postmenopausal women. We will further evaluate the association of lipid and non-lipid factors of ERT-mediated reduction in the progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery. Blood samples will be used for measuring lipid and non-lipid mediators of ERT.
A total of 222 healthy postmenopausal women 46 to 80 years old without CVD symptoms will be randomized to receive either micronized 17B-estradiol (Estrace) 1mg/day, or a matching placebo tablet daily. All women will be on a low fat/low cholesterol diet, and will receive pravastatin if their LDL cholesterol level exceeds 160 mg/dL. Participants will undergo ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment. Measurements of lipid and non-lipid biochemical markers will also be done at baseline and every 6 months.
- Conditions
- Atherosclerosis, Postmenopause
- Being tested
- Micronized 17B-estradiol
- Keywords
- cardiovascular disease, CVD, estrogen, cholesterol, LDL, lipids, postmenopausal
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized 17B-estradiolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Secondary outcomes (1)
lipid and non-lipid factors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2005 (estimated)
- Study startApr 1994
- Primary completionNov 1998
- Study completionNov 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 222 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Mead Johnson Nutrition
- Investigators
- Howard N. Hodis, MD, Principal investigator, University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115024
- Sponsor's protocol ID
- AG0026
- Other IDs
- R01AG018798
- Status last verified
- Jun 2005
- First submitted
- 20 Jun 2005
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, Selzer RH, Liu Cr CR, Liu Ch CH, Azen SP; Estrogen in the Prevention of Atherosclerosis Trial Research Group. Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Dec 4;135(11):939-53. doi: 10.7326/0003-4819-135-11-200112040-00005.
PubMed 11730394Steiner AZ, Xiang M, Mack WJ, Shoupe D, Felix JC, Lobo RA, Hodis HN. Unopposed estradiol therapy in postmenopausal women: results from two randomized trials. Obstet Gynecol. 2007 Mar;109(3):581-7. doi: 10.1097/01.AOG.0000251518.56369.eb.
PubMed 17329508
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen in the Prevention of Atherosclerosis Trial
- ClinicalTrials.gov ID
- NCT00115024
- Acronym / sponsor ID
- AG0026
- Conditions
- Atherosclerosis, Postmenopause
- Keywords
- cardiovascular disease, CVD, estrogen, cholesterol, LDL, lipids, postmenopausal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- Mead Johnson Nutrition
- Study start
- Apr 1994
- Primary completion
- Nov 1998 (actual)
- Study completion
- Nov 1998 (actual)
- First posted
- 21 Jun 2005 (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.
The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (CVD).
Detailed description
The primary goal of this randomized, controlled trial is to determine if ERT stabilizes, retards, and/or reverses the progression of atherosclerosis in postmenopausal women. We will further evaluate the association of lipid and non-lipid factors of ERT-mediated reduction in the progression of early atherosclerosis. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery. Blood samples will be used for measuring lipid and non-lipid mediators of ERT.
A total of 222 healthy postmenopausal women 46 to 80 years old without CVD symptoms will be randomized to receive either micronized 17B-estradiol (Estrace) 1mg/day, or a matching placebo tablet daily. All women will be on a low fat/low cholesterol diet, and will receive pravastatin if their LDL cholesterol level exceeds 160 mg/dL. Participants will undergo ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment. Measurements of lipid and non-lipid biochemical markers will also be done at baseline and every 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 46 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal female (serum estradiol less than 20 pg/ml)
- 46 to 80 years old
- Fasting LDL-C levels 130 to 210 mg/dL
- Triglyceride levels less than 400 mg/dL
- Current non-smoker
Key exclusion criteria (12 listed)
- Clinical evidence of cardiovascular disease
- HDL-C level less than 30 mg/dL
- Fasting blood glucose greater than 200 mg/dL
- Previous hormonal replacement therapy (non-contraceptive) over 10 years duration and/or current use within 1 month
- Uncontrolled hypertension
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 |
|---|---|---|
| Micronized 17B-estradiol | Drug | – |
Primary outcome
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
1 secondary outcome
lipid and non-lipid factors
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 11 Dec 2009.
- Results publication: PubMed 11730394Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, Selzer RH, Liu Cr CR, Liu Ch CH, Azen SP; Estrogen in the Prevention of Atherosclerosis Trial Research Group. Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Dec 4;135(11):939-53. doi: 10.7326/0003-4819-135-11-200112040-00005.
- Derived from this study: PubMed 17329508Steiner AZ, Xiang M, Mack WJ, Shoupe D, Felix JC, Lobo RA, Hodis HN. Unopposed estradiol therapy in postmenopausal women: results from two randomized trials. Obstet Gynecol. 2007 Mar;109(3):581-7. doi: 10.1097/01.AOG.0000251518.56369.eb.
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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.
Howard N. Hodis, MD principal investigator
University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Micronized 17B-estradiol in people with Atherosclerosis and Postmenopause, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2009. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00115024, which also lists 2 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 11 Dec 2009.