Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Heart Association | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| African-American women | Active Comparator | African-American women |
|
| Caucasian women | Active Comparator | Caucasian women |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Acute Insulin Response to Glucose | Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response | Baseline, 6 months |
| Change From Baseline in Glucose Effectiveness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kai Cheang, Pharm. D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298-0111 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | African-American Women | African-American women Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took 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. |
| FG001 | Caucasian Women | Caucasian women Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | African-American Women | African-American women Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took 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. |
| BG001 | Caucasian Women |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | min ^ -1 / mIU / L | Baseline, 6 months |
|
Post-baseline follow-up phone call at 10 days
Superficial venous thrombosis at IV site
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | African-American Women | African-American women Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) was 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. |
Not provided
Not provided
Small numbers of subjects analyzed. Some subjects did not have reportable carotid intima media thickness and flow mediated dilatation values.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kai Cheang | Virginia Commonwealth University | 8049863269 | kicheang@vcu.edu |
Not provided
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)
Not provided
Not provided
Not provided
Not provided
|
Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition
| Baseline, 6 months |
| Change From Baseline in Disposition Index at 6 Months | Modeled from FISVGTT--higher values indicate better glucose disposition | Baseline, 6 months |
| Change From Baseline in Fasting Insulin at 6 Months | Higher fasting insulin values indicate an increased metabolic risk | Baseline, 6 months |
| Change From Baseline in Fasting Glucose at 6 Months | Higher fasting glucose indicate an increased metabolic risk | Baseline, 6 months |
| Change From Baseline in Areas-under-the-curve for Insulin at 6 Months | Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk | Baselines, 6 months |
| Change From Baseline in Areas-under-the-curve for Glucose | Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk | Baseline, 6 months |
| Change From Baseline in Systolic Blood Pressure at 6 Months | Higher value indicates increased cardiovascular risk | Baseline, 6 months |
| Change From Baseline in HDL at 6 Months | Lower values indicate increased cardiovascular risk | Baseline, 6 months |
| Change From Baseline in Body Mass Index in 6 Months | Higher values indicate higher metabolic risk | Baseline, 6 months |
| Change in Diastolic Blood Pressure From Baseline to 6 Months | Higher value indicates higher cardiovascular risk | Baseline, 6 months |
| Change in LDL From Baseline to 6 Months | Higher value indicates higher cardiovascular risk | Baseline, 6 months |
| Change in Triglycerides From Baseline to 6 Months | Higher values indicate higher cardiovascular risk | Baseline, 6 months |
Caucasian women Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) took 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Change From Baseline in Flow-mediated Vasodilatation | Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk | Data based on images. Some participants images could not be analyzed numerically. | Posted | Mean | 95% Confidence Interval | mm | Baseline, 6 months |
|
|
|
| Primary | 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 | Data based on images. Some participants images could not be analyzed numerically. | Posted | Mean | 95% Confidence Interval | mm | baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Acute Insulin Response to Glucose | Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response | Posted | Mean | 95% Confidence Interval | mIU* L^-1 * min | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Glucose Effectiveness | Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition | Posted | Mean | 95% Confidence Interval | 1000 * min ^ -1 | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Disposition Index at 6 Months | Modeled from FISVGTT--higher values indicate better glucose disposition | Posted | Mean | 95% Confidence Interval | AIRG * Si | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Fasting Insulin at 6 Months | Higher fasting insulin values indicate an increased metabolic risk | Posted | Mean | 95% Confidence Interval | uIU/ mL | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Fasting Glucose at 6 Months | Higher fasting glucose indicate an increased metabolic risk | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Areas-under-the-curve for Insulin at 6 Months | Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk | Posted | Mean | 95% Confidence Interval | mIU/mL * min | Baselines, 6 months |
|
|
|
| Secondary | Change From Baseline in Areas-under-the-curve for Glucose | Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk | Posted | Mean | 95% Confidence Interval | mg/dL * min | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Systolic Blood Pressure at 6 Months | Higher value indicates increased cardiovascular risk | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in HDL at 6 Months | Lower values indicate increased cardiovascular risk | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, 6 months |
|
|
|
| Secondary | Change From Baseline in Body Mass Index in 6 Months | Higher values indicate higher metabolic risk | Posted | Mean | 95% Confidence Interval | Kg/m2 | Baseline, 6 months |
|
|
|
| Secondary | Change in Diastolic Blood Pressure From Baseline to 6 Months | Higher value indicates higher cardiovascular risk | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, 6 months |
|
|
|
| Secondary | Change in LDL From Baseline to 6 Months | Higher value indicates higher cardiovascular risk | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, 6 months |
|
|
|
| Secondary | Change in Triglycerides From Baseline to 6 Months | Higher values indicate higher cardiovascular risk | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline, 6 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Caucasian Women | Caucasian women Ortho Cyclen®: Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) was 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. | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
Not provided
| D006943 | Hyperglycemia |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |