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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

November 8, 2011
June 11, 2013
November 2011
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01475513 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Yes ]
  • Change from Baseline in Glucose Effectiveness in 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Disposition Index at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Fasting Insulin at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Fasting Glucose at 6 months [ Time Frame: Baseline, 3 monhts, 6 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Areas-under-the-curve for Insulin at 6 months [ Time Frame: Baselines, 3 months, 6 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Areas-under-the-curve for Glucose at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Cardiovascular Markers (hsCRP, MCP-1, ICAM-1, V-CAM-1, PAI-1, tPA, RBP4) at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Blood Pressure at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Fasting Lipid Panel at 6 months [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Insulin Sensitivity
  • Cardiovascular Risk
  • Perimenopausal Disorder
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: African-American women
    African-American women
    Intervention: Drug: Ortho Cyclen®
  • Active Comparator: Caucasian women
    Caucasian women
    Intervention: Drug: Ortho Cyclen®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact: Kai Cheang, Pharm. D. 804-828-9698 KICHEANG@VCU.EDU
United States
 
NCT01475513
HM13769
No
Virginia Commonwealth University
Virginia Commonwealth University
American Heart Association
Principal Investigator: Kai Cheang, Pharm. D. Virginia Commonwealth University
Virginia Commonwealth University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP