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Trial record 98 of 264 for:    Estrogen Resistance

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

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ClinicalTrials.gov Identifier: NCT01475513
Recruitment Status : Completed
First Posted : November 21, 2011
Results First Posted : July 10, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Cardiovascular Risk Perimenopausal Disorder Drug: Ortho Cyclen® Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Study Start Date : November 2011
Actual Primary Completion Date : May 28, 2014
Actual Study Completion Date : May 28, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change From Baseline in Insulin Sensitivity [ Time Frame: Baseline, 6 months ]
    Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity

  2. Change From Baseline in Flow-mediated Vasodilatation [ Time Frame: Baseline, 6 months ]
    Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk

  3. Change From Baseline in Carotid Intima Media Thickness [ Time Frame: baseline, 6 months ]
    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


Secondary Outcome Measures :
  1. Change From Baseline in Acute Insulin Response to Glucose [ Time Frame: Baseline, 6 months ]
    Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response

  2. Change From Baseline in Glucose Effectiveness [ Time Frame: Baseline, 6 months ]
    Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition

  3. Change From Baseline in Disposition Index at 6 Months [ Time Frame: Baseline, 6 months ]
    Modeled from FISVGTT--higher values indicate better glucose disposition

  4. Change From Baseline in Fasting Insulin at 6 Months [ Time Frame: Baseline, 6 months ]
    Higher fasting insulin values indicate an increased metabolic risk

  5. Change From Baseline in Fasting Glucose at 6 Months [ Time Frame: Baseline, 6 months ]
    Higher fasting glucose indicate an increased metabolic risk

  6. Change From Baseline in Areas-under-the-curve for Insulin at 6 Months [ Time Frame: Baselines, 6 months ]
    Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk

  7. Change From Baseline in Areas-under-the-curve for Glucose [ Time Frame: Baseline, 6 months ]
    Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk

  8. Change From Baseline in Systolic Blood Pressure at 6 Months [ Time Frame: Baseline, 6 months ]
    Higher value indicates increased cardiovascular risk

  9. Change From Baseline in HDL at 6 Months [ Time Frame: Baseline, 6 months ]
    Lower values indicate increased cardiovascular risk

  10. Change From Baseline in Body Mass Index in 6 Months [ Time Frame: Baseline, 6 months ]
    Higher values indicate higher metabolic risk

  11. Change in Diastolic Blood Pressure From Baseline to 6 Months [ Time Frame: Baseline, 6 months ]
    Higher value indicates higher cardiovascular risk

  12. Change in LDL From Baseline to 6 Months [ Time Frame: Baseline, 6 months ]
    Higher value indicates higher cardiovascular risk

  13. Change in Triglycerides From Baseline to 6 Months [ Time Frame: Baseline, 6 months ]
    Higher values indicate higher cardiovascular risk



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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

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

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01475513     History of Changes
Other Study ID Numbers: HM13769
First Posted: November 21, 2011    Key Record Dates
Results First Posted: July 10, 2018
Last Update Posted: August 8, 2018
Last Verified: July 2018
Keywords provided by Virginia Commonwealth University:
insulin resistance
estrogen metabolism
oral contraceptive
birth control pill
women
healthy volunteer
insulin sensitivity
cardiovascular risk factors
endothelial function
racial difference
glucose intolerance
Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Contraceptive Agents
Contraceptives, Oral
Hypoglycemic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female