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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Virginia Commonwealth University
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01475513
First received: November 8, 2011
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Insulin Sensitivity
Cardiovascular Risk
Perimenopausal Disorder
Drug: Ortho Cyclen®
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change from Baseline in Estrogen Metabolites at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Insulin Sensitivity at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Flow-mediated Vasodilatation at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Carotid Intima Media Thickness at 6 months [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Urinary Estrogen Metabolites at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Acute Insulin Response to Glucose at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Glucose Effectiveness in 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Disposition Index at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Insulin at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Glucose at 6 months [ Time Frame: Baseline, 3 monhts, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Areas-under-the-curve for Insulin at 6 months [ Time Frame: Baselines, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Areas-under-the-curve for Glucose at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Blood Pressure at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Lipid Panel at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Mass Index in 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Waist-to-hip Ratio at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Serum free fatty acids [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: November 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: African-American women
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:
  • Orthocyclen
  • Sprintec
  • Previfem
  • MonoNessa
Active Comparator: Caucasian women
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:
  • Orthocyclen
  • Sprintec
  • Previfem
  • MonoNessa

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475513

Contacts
Contact: Kai Cheang, Pharm. D. 804-828-9698 KICHEANG@VCU.EDU

Locations
United States, Virginia
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298-0111
Contact: Kai Cheang, Pharm. D.       kicheang@vcu.edu   
Principal Investigator: Kai Cheang, Pharm. D.         
Sponsors and Collaborators
Virginia Commonwealth University
American Heart Association
Investigators
Principal Investigator: Kai Cheang, Pharm. D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01475513     History of Changes
Other Study ID Numbers: HM13769
Study First Received: November 8, 2011
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
insulin sensitivity
insulin resistance
oral contraceptive
birth control pill
women
healthy volunteer
cardiovascular risk factors
endothelial function
estrogen metabolism
racial difference
glucose intolerance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Insulin
Moxifloxacin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Hypoglycemic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 14, 2014