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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01475513
First Posted: November 21, 2011
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Virginia Commonwealth University
  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: None (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 ]
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 47
Study Start Date: November 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475513


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

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01475513     History of Changes
Other Study ID Numbers: HM13769
First Submitted: November 8, 2011
First Posted: November 21, 2011
Last Update Posted: March 24, 2017
Last Verified: March 2017

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

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