Status:
COMPLETED
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
American Heart Association
Conditions:
Insulin Sensitivity
Cardiovascular Risk
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
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 ...
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 hea...
Eligibility Criteria
Inclusion
- Premenopausal, regular-cycling women 18-35 years
- Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
- non-smoker.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01475513
Start Date
November 1 2011
End Date
May 28 2014
Last Update
August 8 2018
Active Locations (1)
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1
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298-0111