Status:
COMPLETED
Oral Contraceptives in the Metabolic Syndrome
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Metabolic Syndrome X
Insulin Resistance
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief 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 sti...
Eligibility Criteria
Inclusion
- Acceptable health based on interview, medical history, physical examination, and laboratory tests (comprehensive metabolic panel - SMA20, and complete blood count - CBC);
- Have not taken oral contraceptives (OCs) in the past 3 months;
- Ability to comply with the requirements of the study;
- 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:
- increased waist circumference \> 35 inches,
- hypertriglyceridemia ≥ 150 mg/dL,
- low high-density lipoprotein (HDL) cholesterol \< 50 mg/dL in women,
- hypertension (≥ 130/≥ 85 mmHg),
- fasting glucose ≥ 100 mg/dL.
- Obese women with or without the metabolic syndrome should have a Body Mass Index (BMI) \> 30 kg/m2 and lean women should have a Body Mass Index BMI \< 25 kg/m2.
Exclusion
- Diabetes mellitus by fasting glucose or a 2-hour oral glucose tolerance test (OGTT);
- Clinically significant pulmonary, cardiac (including but not limited to ischemic heart disease, stable/unstable angina, and congestive heart failure), renal, hepatic, cholestatic, neurologic, psychiatric, infectious, and malignant disease (other than melanoma skin cancer);
- History of thromboembolism, myocardial infarction, cerebrovascular accident, vascular disease, known coagulopathy, prolonged immobilization, or recent major surgery (within past 6 months);
- Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg (mild hypertension is not an exclusion criterion);
- History of breast cancer, migraine headaches, or age ≥ 35 years and smoker of ≥ 20 cigarettes/day;
- Use of metformin, thiazolidinediones, anti-hyperlipidemic drugs, anti-hypertensive drugs, glucocorticoids, or anti-androgens (spironolactone, flutamide, etc.) within 3 months;
- Documented or suspected illicit drug abuse or alcoholism within one year;
- Ingestion of any investigational drugs within 3 months prior to the study onset; and
- Pregnancy or lactation (≤ 6 weeks postpartum);
- Hematocrit \< 33g/dL. These exclusion criteria are based on study requirements and also go beyond guidelines for OC use published by the World Health Organization.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00205504
Start Date
June 1 2005
End Date
June 1 2009
Last Update
August 8 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University General Clinical Research Center
Richmond, Virginia, United States, 23298