Conditions: Insulin Sensitivity Cardiovascular Risk Perimenopausal Disorder
Keywords: oral contraceptive birth control pill women healthy volunteer insulin sensitivity insulin resistance cardiovascular risk factors endothelial function estrogen metabolism racial difference glucose intolerance
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: African-American women arm 2: Caucasian women

Interventions: intervention 1: Ortho Cyclen®
Intervention descriptions: intervention 1: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.

Protocol document: