At a glance
ClinicalIndex Comparison Record- ✓Acceptable health based on clinical evaluation (interview, history, physical exam, comprehensive metabolic panel/CBC)
- ✓No oral contraceptives in the past 3 months
- ✓For metabolic syndrome: ≥3 of 5 NCEP criteria (waist circumference >35", triglycerides ≥150 mg/dL, HDL <50 mg/dL, BP ≥130/85 mmHg, fasting glucose ≥100 mg/dL)
- ✓Obese women: BMI >30 kg/m²; lean women: BMI <25 kg/m²
- ✕Diabetes mellitus (fasting glucose or 2-hour OGTT)
- ✕Clinically significant pulmonary, cardiac (ischemic heart disease, angina, heart failure), renal, hepatic, cholestatic, neurologic, psychiatric, infectious, or malignant disease (except melanoma)
- ✕History of thromboembolism, myocardial infarction, cerebrovascular accident, vascular disease, coagulopathy, prolonged immobilization, or major surgery within past 6 months
- ✕Severe hypertension: systolic >160 mmHg or diastolic >100 mmHg
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Oral Contraceptives in the Metabolic Syndrome
In Brief
A Phase 4 clinical trial evaluating Ortho Tri Cyclen for Metabolic Syndrome X and 3 related conditions. Completed, enrolled 46 participants across 1 site.
Detailed Summary
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 (such as obesity and the metabolic syndrome) have not been investigated. 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 and obesity affects glucose metabolism and cardiovascular risks in women taking OCs. The researchers hypothesize that women with metabolic syndrome and obese women will have worsened glucose metabolism and elevated cardiovascular risks associated with OC use, when compared to normal weight women without the metabolic syndrome. 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.
Study Details
Timeline
Interventions
Ortho Tri Cyclen, one tablet daily, for 6 cycles