NCT01475513

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insulin Sensitivity
• Cardiovascular Risk
• Perimenopausal Disorder

Interventions

Type	Name	Description
DRUG	Ortho Cyclen®	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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-05-28
• Completion: 2014-05-28
• First posted: 2011-11-21
• Last updated: 2018-08-08
• Results posted: 2018-07-10

Locations

1 site across 1 country: United States