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Sponsored by: |
Virginia Commonwealth University |
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Information provided by: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00205504 |
Oral contraceptives (OCs) are the most widely used method of reversible birth control. However, the long-term cardiovascular safety of the widely used low-dose OCs (ethinyl-estradiol < 50 mcg) is still debated. Although cardiovascular events are rare in young women whether they use OCs or not, the risks of myocardial infarction and ischemic stroke are increased among users of OCs who have conventional cardiovascular risk factors such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular events in OC users with emerging cardiovascular risk factors have not been investigated. One such emerging cardiovascular risk factor is the metabolic syndrome. Recently, the metabolic syndrome has been linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors in a single individual, and its underlying cause may be insulin resistance. Whether the metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied. This is a critical problem because the metabolic syndrome is prevalent in 24% of adults. Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC with the least harm would not be possible.
The investigator's long-term goal is to understand the best way to prevent and treat cardiovascular disease in women. The objective of this particular project is to obtain pilot data on the extent to which the metabolic syndrome affects cardiovascular risks in women taking OCs. The researchers hypothesize that the metabolic syndrome predicts higher cardiovascular risks in OC users. Results of this study will clarify the risk factors for cardiovascular events in women taking OCs, and will serve as pilot data for a National Institutes of Health (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians can make better informed decisions about contraceptive choices for their patients.
Condition | Intervention | Phase |
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Metabolic Syndrome X Insulin Resistance Obesity Cardiovascular Diseases |
Drug: Ortho Tri Cyclen |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Oral Contraceptives in the Metabolic Syndrome |
Estimated Enrollment: | 40 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | November 2008 |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Ability and willingness to provide signed, witnessed informed consent. In addition, women with the metabolic syndrome must meet the National Cholesterol Education Program (NCEP) defined criteria of the metabolic syndrome, that is, having at least 3 of the 5 factors:
To eliminate weight as a confounding factor in the study, women in the control group without the metabolic syndrome should have an increased waist circumference > 35 inches or a body mass index (BMI) > 26.7kg/m2, a value that corresponds to a waist circumference of 35 inches.
10 lean normal weight women (BMI <= 25 kg/m2) will serve as a comparison group.
Exclusion Criteria:
Contact: Kai I Cheang, Pharm.D. | 804-828-9698 | kicheang@vcu.edu |
United States, Virginia | |
Virginia Commonwealth University General Clinical Research Center | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Kai I Cheang, Pharm.D. 804-828-9698 kicheang@vcu.edu | |
Principal Investigator: Kai I Cheang, Pharm.D. | |
Sub-Investigator: John E Nestler, M.D. | |
Sub-Investigator: Paulina A Essah, M.D. |
Principal Investigator: | Kai I Cheang, Pharm.D. | Virginia Commonwealth University |
Study Director: | John E Nestler, M.D. | Virginia Commonwealth University |
Study Director: | Paulina A Essah, M.D. | Virginia Commonwealth University |
Study ID Numbers: | AD Williams |
Study First Received: | September 13, 2005 |
Last Updated: | July 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00205504 |
Health Authority: | United States: Institutional Review Board |
Inflammatory markers |
Obesity Metabolic Syndrome X Metabolic Diseases Overweight Body Weight Hyperinsulinism Signs and Symptoms Moxifloxacin |
Syndrome X Nutrition Disorders Overnutrition Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Abdominal obesity metabolic syndrome |
Anti-Infective Agents Pathologic Processes Disease Therapeutic Uses |
Syndrome Cardiovascular Diseases Pharmacologic Actions |