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

NCT01475513 | Completed Phase 4 Results

• 1 other identifier: HM13769
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 blood sugar when given to different women.

Conditions

Insulin Sensitivity; Cardiovascular Risk; Perimenopausal Disorder

Keywords

oral contraceptive; birth control pill; women; healthy volunteer; insulin sensitivity; insulin resistance; cardiovascular risk factors; endothelial function; estrogen metabolism; racial difference; glucose intolerance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• Change From Baseline in Acute Insulin Response to Glucose

  Baseline, 6 months

• Change From Baseline in Glucose Effectiveness

  Baseline, 6 months

• Change From Baseline in Disposition Index at 6 Months

  Baseline, 6 months

• Change From Baseline in Fasting Insulin at 6 Months

  Baseline, 6 months

• Change From Baseline in Fasting Glucose at 6 Months

  Baseline, 6 months

Study Arms (2)

African-American women

ACTIVE COMPARATOR

African-American women

Drug: Ortho Cyclen®

Caucasian women

ACTIVE COMPARATOR

Caucasian women

Drug: Ortho Cyclen®

Interventions

Ortho Cyclen® DRUG

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.

Also known as: Orthocyclen, Sprintec, Previfem, MonoNessa

African-American women; Caucasian women

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal, regular-cycling women 18-35 years
• Either African-American or Caucasian (African-American and Caucasian women will be BMI-matched)
• non-smoker.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Heart Association: collaborator

Study Sites (1)

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298-0111, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Small numbers of subjects analyzed. Some subjects did not have reportable carotid intima media thickness and flow mediated dilatation values.

Results Point of Contact

• Title: Kai Cheang
• Organization: Virginia Commonwealth University

kicheang@vcu.edu

8049863269

Study Officials

• Kai Cheang, Pharm. D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: May 28, 2014
• Study Completion: May 28, 2014
• Last Updated: August 8, 2018
• Results First Posted: July 10, 2018

Record last verified: 2018-07

Locations

US (1)