MenopausePhase 4NCT00361075
Midlife Cholesterol Study
A Phase 4 study testing transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium) in people with Menopause and Postmenopause, run by Northwestern University at 2 sites in United States.
Trial summary
The postmenopausal state is associated with an increase risk for heart disease. Much of this increase in risk may be due to the loss of estrogen (the main female hormone) and the effect of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen replacement therapy. Read more about this study
- Who is it for?
- Ages 47 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Postmenopause, Premenopause
- What is being tested?
- transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium)
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1998to May 2005
- Phase
- Phase 4
- 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 47 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have demonstrated an interest to participate in the ERT trial
- Be premenopausal (have menstrual period in previous three months) prior to start of observational arm
- Prior to start of interventional arm (ERT), the women must be postmenopausal (have not had a menstrual cycle in the past twelve months and FSH >30)
- Be between the ages of 47 and 55
- Not be taking any form of estrogen replacement
- Have an intact uterus and at least one ovary and normal screening mammogram in the 12 months prior to starting ERT
Who cannot join
- Body mass index (kg/m2) greater than 40 kg/m2
- History of diabetes mellitus or fasting >110 mg/dl at screening
- Abnormal fasting LDL or triglyceride
- Use of lipid lowering medications, beta-blockers, birth control pills
- Active liver disease (recent history of active hepatitis, jaundice, scleral icterus, and/or elevated liver function tests
- History of breast, endometrial or ovarian cancer
- History of thrombotic disorder (past history of pulmonary embolus or deep venous thrombosis) or known history of CAD
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
University of Washington
Seattle, Washington, 98195
About this study
Official title: Mentored Patient Oriented Research Career Development Award
The postmenopausal state is associated with an increase risk for heart disease. Much of this increase in risk may be due to the loss of estrogen (the main female hormone) and the effect of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen replacement therapy. Estrogen replacement therapy seems to have a beneficial effect on lipid levels. The purpose of this research study is to understand 1) how menopause affects lipids and 2) how hormone replacement therapy effects the lipid metabolism of postmenopausal women.
Read the detailed description
Women with the Metabolic Syndrome (central obesity, insulin resistance, and dyslipidemia) are at especially high risk for coronary heart disease (CHD). The prevalence of the Metabolic Syndrome increases with menopause and may partially explain the acceleration in CHD after menopause. Menopause is associated with increased central adiposity, insulin resistance, dyslipidemia (hypertriglyceridemia, increased low density lipoprotein (LDL), reduced high density lipoprotein (HDL) and small dense LDL particles), and increased thrombotic/inflammatory states, but there are no studies investigating the mechanisms that mediate these changes. The objectives of the proposed project are to investigate the emergence of the features of the Metabolic Syndrome in women followed prospectively through the menopause and determine if these features can be reversed with transdermal estrogen. We hypothesize that the increase in central adiposity with menopause will be a major contributor to the increased prevalence of the Metabolic Syndrome with menopause. This is the first prospective study to investigate the 1) effects of menopause and 2) estrogen replacement therapy (ERT) (oral vs. transdermal) on features of the Metabolic Syndrome. We will determine if the increase in central (intraabdominal)fat with menopause is associated with changes in lipids, insulin resistance, adipocytokines, and fibrinolytic/inflammatory markers. We will then determine if these changes can be reversed with transdermal ERT, as compared to oral ERT, which has pharmacologic effects on the liver.
- Conditions
- Menopause, Postmenopause, Premenopause, Cardiovascular Disease
- Being tested
- transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium)
- Keywords
- Perimenopause, Abdominal adipose tissue, Women's health, Cholesterol, Lipid Metabolism
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL particle size and density
Secondary outcomes (5)
Total body adiposity (Dexa scans)
Intra-abdominal fat (CT scans)
Lipid Profile
Inflammatory Factors
Adipocytokines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startJul 1998
- Study completionMay 2005
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 MenopauseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Investigators
- Molly C. Carr, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361075
- Sponsor's protocol ID
- 5K23RR016067-05
- Status last verified
- Nov 2014
- First submitted
- 3 Aug 2006
- Last updated
- 5 Nov 2014
- Results posted
- No
Publications
Carr MC, Hokanson JE, Deeb SS, Purnell JQ, Mitchell ES, Brunzell JD. A hepatic lipase gene promoter polymorphism attenuates the increase in hepatic lipase activity with increasing intra-abdominal fat in women. Arterioscler Thromb Vasc Biol. 1999 Nov;19(11):2701-7. doi: 10.1161/01.atv.19.11.2701.
PubMed 10559014Carr MC, Kim KH, Zambon A, Mitchell ES, Woods NF, Casazza CP, Purnell JQ, Hokanson JE, Brunzell JD, Schwartz RS. Changes in LDL density across the menopausal transition. J Investig Med. 2000 Jul;48(4):245-50.
PubMed 10916282
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentored Patient Oriented Research Career Development Award
- ClinicalTrials.gov ID
- NCT00361075
- Acronym / sponsor ID
- 5K23RR016067-05
- Conditions
- Menopause, Postmenopause, Premenopause, Cardiovascular Disease
- Keywords
- Perimenopause, Abdominal adipose tissue, Women's health, Cholesterol, Lipid Metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Jul 1998
- Study completion
- May 2005 (actual)
- First posted
- 7 Aug 2006 (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 postmenopausal state is associated with an increase risk for heart disease. Much of this increase in risk may be due to the loss of estrogen (the main female hormone) and the effect of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen replacement therapy. Estrogen replacement therapy seems to have a beneficial effect on lipid levels. The purpose of this research study is to understand 1) how menopause affects lipids and 2) how hormone replacement therapy effects the lipid metabolism of postmenopausal women.
Detailed description
Women with the Metabolic Syndrome (central obesity, insulin resistance, and dyslipidemia) are at especially high risk for coronary heart disease (CHD). The prevalence of the Metabolic Syndrome increases with menopause and may partially explain the acceleration in CHD after menopause. Menopause is associated with increased central adiposity, insulin resistance, dyslipidemia (hypertriglyceridemia, increased low density lipoprotein (LDL), reduced high density lipoprotein (HDL) and small dense LDL particles), and increased thrombotic/inflammatory states, but there are no studies investigating the mechanisms that mediate these changes. The objectives of the proposed project are to investigate the emergence of the features of the Metabolic Syndrome in women followed prospectively through the menopause and determine if these features can be reversed with transdermal estrogen. We hypothesize that the increase in central adiposity with menopause will be a major contributor to the increased prevalence of the Metabolic Syndrome with menopause. This is the first prospective study to investigate the 1) effects of menopause and 2) estrogen replacement therapy (ERT) (oral vs. transdermal) on features of the Metabolic Syndrome. We will determine if the increase in central (intraabdominal)fat with menopause is associated with changes in lipids, insulin resistance, adipocytokines, and fibrinolytic/inflammatory markers. We will then determine if these changes can be reversed with transdermal ERT, as compared to oral ERT, which has pharmacologic effects on the liver.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 47 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have demonstrated an interest to participate in the ERT trial
- Be premenopausal (have menstrual period in previous three months) prior to start of observational arm
- Prior to start of interventional arm (ERT), the women must be postmenopausal (have not had a menstrual cycle in the past twelve months and FSH >30)
- Be between the ages of 47 and 55
- Not be taking any form of estrogen replacement
Key exclusion criteria (7 listed)
- Body mass index (kg/m2) greater than 40 kg/m2
- History of diabetes mellitus or fasting >110 mg/dl at screening
- Abnormal fasting LDL or triglyceride
- Use of lipid lowering medications, beta-blockers, birth control pills
- Active liver disease (recent history of active hepatitis, jaundice, scleral icterus, and/or elevated liver function tests
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 |
|---|---|---|
| transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium) | Drug | – |
Primary outcome
LDL particle size and density
5 secondary outcomes
Total body adiposity (Dexa scans)
Intra-abdominal fat (CT scans)
Lipid Profile
Inflammatory Factors
Adipocytokines
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 5 Nov 2014.
- Background: PubMed 10559014Carr MC, Hokanson JE, Deeb SS, Purnell JQ, Mitchell ES, Brunzell JD. A hepatic lipase gene promoter polymorphism attenuates the increase in hepatic lipase activity with increasing intra-abdominal fat in women. Arterioscler Thromb Vasc Biol. 1999 Nov;19(11):2701-7. doi: 10.1161/01.atv.19.11.2701.
- Background: PubMed 10916282Carr MC, Kim KH, Zambon A, Mitchell ES, Woods NF, Casazza CP, Purnell JQ, Hokanson JE, Brunzell JD, Schwartz RS. Changes in LDL density across the menopausal transition. J Investig Med. 2000 Jul;48(4):245-50.
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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.
Molly C. Carr, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium) in people with Menopause and Postmenopause, run by Northwestern University at 2 sites 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 6 inclusion and 7 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
LDL particle size and density. 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 NCT00361075, 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 5 Nov 2014.