Phase 4 N=46 Screening

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

Insulin Sensitivity · Cardiovascular Risk · Perimenopausal Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01475513 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Change From Baseline in Insulin Sensitivity — -1.91; -5.63 min ^ -1 / mIU / L

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ortho Cyclen® (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Virginia Commonwealth University
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Insulin Sensitivity	-1.91; -5.63	—
PRIMARY Change From Baseline in Flow-mediated Vasodilatation	0.0503; -0.0210	—
PRIMARY Change From Baseline in Carotid Intima Media Thickness	-0.00008; 0.00118	—
SECONDARY Change From Baseline in Acute Insulin Response to Glucose	-35.6; 0.48	—
SECONDARY Change From Baseline in Glucose Effectiveness	-0.0255; -0.0078	—
SECONDARY Change From Baseline in Disposition Index at 6 Months	-911.73; -834.53	—
SECONDARY Change From Baseline in Fasting Insulin at 6 Months	1.66; 1.45	—
SECONDARY Change From Baseline in Fasting Glucose at 6 Months	-0.4; 03	—
SECONDARY Change From Baseline in Areas-under-the-curve for Insulin at 6 Months	760.6; 1062.1	—
SECONDARY Change From Baseline in Areas-under-the-curve for Glucose	443.4; 514.2	—
SECONDARY Change From Baseline in Systolic Blood Pressure at 6 Months	2.5; -1.4	—
SECONDARY Change From Baseline in HDL at 6 Months	6.8; 6.9	—
SECONDARY Change From Baseline in Body Mass Index in 6 Months	-0.32; 0.39	—
SECONDARY Change in Diastolic Blood Pressure From Baseline to 6 Months	0.6; 2.44	—
SECONDARY Change in LDL From Baseline to 6 Months	13.4; 17.1	—
SECONDARY Change in Triglycerides From Baseline to 6 Months	13.3; 29.3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01475513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.