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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk; Insulin Sensitivity; Perimenopausal Disorder
• Intervention / Treatment: Drug: Ortho Cyclen®

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298-0111
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: African-American women	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.; Other Names: Sprintec; Orthocyclen; Previfem; MonoNessa
Active Comparator: Caucasian women	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.; Other Names: Sprintec; Orthocyclen; Previfem; MonoNessa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Insulin Sensitivity	Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity	Baseline, 6 months
Change From Baseline in Flow-mediated Vasodilatation	Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk	Baseline, 6 months
Change From Baseline in Carotid Intima Media Thickness	Change in Carotid Intima Media Thickness from baseline to 6 months, measured on the right carotid artery, posterior. Lower values indicate better cardiovascular risk profile	baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Acute Insulin Response to Glucose	Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response	Baseline, 6 months
Change From Baseline in Glucose Effectiveness	Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition	Baseline, 6 months
Change From Baseline in Disposition Index at 6 Months	Modeled from FISVGTT--higher values indicate better glucose disposition	Baseline, 6 months
Change From Baseline in Fasting Insulin at 6 Months	Higher fasting insulin values indicate an increased metabolic risk	Baseline, 6 months
Change From Baseline in Fasting Glucose at 6 Months	Higher fasting glucose indicate an increased metabolic risk	Baseline, 6 months
Change From Baseline in Areas-under-the-curve for Insulin at 6 Months	Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk	Baselines, 6 months
Change From Baseline in Areas-under-the-curve for Glucose	Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk	Baseline, 6 months
Change From Baseline in Systolic Blood Pressure at 6 Months	Higher value indicates increased cardiovascular risk	Baseline, 6 months
Change From Baseline in HDL at 6 Months	Lower values indicate increased cardiovascular risk	Baseline, 6 months
Change From Baseline in Body Mass Index in 6 Months	Higher values indicate higher metabolic risk	Baseline, 6 months
Change in Diastolic Blood Pressure From Baseline to 6 Months	Higher value indicates higher cardiovascular risk	Baseline, 6 months
Change in LDL From Baseline to 6 Months	Higher value indicates higher cardiovascular risk	Baseline, 6 months
Change in Triglycerides From Baseline to 6 Months	Higher values indicate higher cardiovascular risk	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Kai Cheang, Pharm. D., Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 28, 2014
• Study Completion (Actual): May 28, 2014

Study Registration Dates

• First Submitted: November 8, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 21, 2011

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: insulin sensitivity; healthy volunteer; insulin resistance; women; cardiovascular risk factors; endothelial function; glucose intolerance; oral contraceptive; estrogen metabolism; birth control pill; racial difference
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Hyperinsulinism; Hypersensitivity; Insulin Resistance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: HM13769