Overview

This trial is active, not recruiting.

Conditions insulin sensitivity, cardiovascular risk, perimenopausal disorder
Treatment ortho cyclen®
Phase phase 4
Sponsor Virginia Commonwealth University
Collaborator American Heart Association
Start date November 2011
End date December 2016
Trial size 47 participants
Trial identifier NCT01475513, HM13769

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
African-American women
ortho cyclen® Orthocyclen
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.
(Active Comparator)
Caucasian women
ortho cyclen® Orthocyclen
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.

Primary Outcomes

Measure
Change from Baseline in Estrogen Metabolites at 6 months
time frame: Baseline, 3 months, 6 months
Change from Baseline in Insulin Sensitivity at 6 months
time frame: baseline, 3 months, 6 months
Change from Baseline in Flow-mediated Vasodilatation at 6 months
time frame: baseline, 3 months, 6 months
Change from Baseline in Carotid Intima Media Thickness at 6 months
time frame: baseline, 3 months, 6 months

Secondary Outcomes

Measure
Change from Baseline in Urinary Estrogen Metabolites at 6 months
time frame: Baseline, 3 months, 6 months
Change from Baseline in Acute Insulin Response to Glucose at 6 months
time frame: Baseline, 6 months
Change from Baseline in Glucose Effectiveness in 6 months
time frame: Baseline, 6 months
Change from Baseline in Disposition Index at 6 months
time frame: Baseline, 6 months
Change from Baseline in Fasting Insulin at 6 months
time frame: Baseline, 3 months, 6 months
Change from Baseline in Fasting Glucose at 6 months
time frame: Baseline, 3 monhts, 6 months
Change from Baseline in Areas-under-the-curve for Insulin at 6 months
time frame: Baselines, 3 months, 6 months
Change from Baseline in Areas-under-the-curve for Glucose at 6 months
time frame: Baseline, 3 months, 6 months
Change from Baseline in Cardiovascular Markers (hsCRP, MCP-1, ICAM-1, V-CAM-1, PAI-1, tPA, RBP4, adiponectin, MMP, MPO) at 6 months
time frame: Baseline, 3 months, 6 months
Change from Baseline in Blood Pressure at 6 months
time frame: Baseline, 3 months, 6 months
Change from Baseline in Fasting Lipid Panel at 6 months
time frame: Baseline, 3 months, 6 months
Change from Baseline in Body Mass Index in 6 months
time frame: Baseline, 3 months, 6 months
Change from Baseline in Waist-to-hip Ratio at 6 months
time frame: Baseline, 3 months, 6 months
Hemoglobin A1c
time frame: Baseline, 3 months, 6 months
Serum free fatty acids
time frame: baseline, 3 months, 6 months

Eligibility Criteria

Female participants from 18 years up to 35 years old.

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

Additional Information

Official title Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Principal investigator Kai Cheang, Pharm. D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.