Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women

• Change from Baseline in Estrogen Metabolites at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
• Change from Baseline in Insulin Sensitivity at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Flow-mediated Vasodilatation at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Carotid Intima Media Thickness at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

• Change from Baseline in Urinary Estrogen Metabolites at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
• Change from Baseline in Acute Insulin Response to Glucose at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Glucose Effectiveness in 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Disposition Index at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Fasting Insulin at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Fasting Glucose at 6 months [ Time Frame: Baseline, 3 monhts, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Areas-under-the-curve for Insulin at 6 months [ Time Frame: Baselines, 3 months, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Areas-under-the-curve for Glucose at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Cardiovascular Markers (hsCRP, MCP-1, ICAM-1, V-CAM-1, PAI-1, tPA, RBP4) at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Blood Pressure at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Fasting Lipid Panel at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
• Change from Baseline in Body Mass Index in 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
• Change from Baseline in Waist-to-hip Ratio at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Birth control pills are the most commonly used method of birth control. The purpose of this research study is to examine whether birth control pills change heart disease risk and how the body handles blood sugar when given to different women.

The oral contraceptive pill is the most commonly used birth control method. It is debated whether the birth control pill affects how the body handles insulin and sugar, or whether the pill changes heart disease risk. The goal of this study is to evaluate whether certain factors, such as how the body processes hormones, and demographic factors (e.g. body weight and race), influence how the pill affects the handling of insulin and sugar, and heart health.

• Insulin Sensitivity
• Cardiovascular Risk
• Perimenopausal Disorder

• Active Comparator: African-American women
  African-American women
  Intervention: Drug: Ortho Cyclen®
• Active Comparator: Caucasian women
  Caucasian women
  Intervention: Drug: Ortho Cyclen®

Inclusion Criteria:

• Premenopausal, regular-cycling women 18-35 years
• Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
• non-smoker.

Exclusion Criteria:

• Diabetes
• Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, and malignant disease
• Contraindications to oral contraceptive use (history of blood clots, heart attacks or stroke, vascular disease, coagulopathy, prolonged immobilization, breast cancer, migraine head-aches, major surgery within past 6 months, blood pressure >160/100 mmHg, pregnancy or lactation)
• Use of hormonal contraceptives, glucose-lowering medications, anti-hyperlipidemic, anti-hypertensive or other vasoactive drugs within previous 3 months