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

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01475513
• Collaborator: American Heart Association (Other)
• Enrollment: 47
• Location: 1
• Arms: 2
• Duration (Months): 30.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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)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: Nov 1, 2011
• Actual Primary Completion Date: May 28, 2014
• Actual Study Completion Date: May 28, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Insulin Sensitivity [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 [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 [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 [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 [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 [Baseline, 6 months]

   Modeled from FISVGTT--higher values indicate better glucose disposition

4. Change From Baseline in Fasting Insulin at 6 Months [Baseline, 6 months]

   Higher fasting insulin values indicate an increased metabolic risk

5. Change From Baseline in Fasting Glucose at 6 Months [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 [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 [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 [Baseline, 6 months]

   Higher value indicates increased cardiovascular risk

9. Change From Baseline in HDL at 6 Months [Baseline, 6 months]

   Lower values indicate increased cardiovascular risk

10. Change From Baseline in Body Mass Index in 6 Months [Baseline, 6 months]

    Higher values indicate higher metabolic risk

11. Change in Diastolic Blood Pressure From Baseline to 6 Months [Baseline, 6 months]

    Higher value indicates higher cardiovascular risk

12. Change in LDL From Baseline to 6 Months [Baseline, 6 months]

    Higher value indicates higher cardiovascular risk

13. Change in Triglycerides From Baseline to 6 Months [Baseline, 6 months]

    Higher values indicate higher cardiovascular risk

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT01475513
• Other Study ID Numbers: HM13769
• First Posted: Nov 21, 2011
• Last Update Posted: Aug 8, 2018
• Last Verified: Jul 1, 2018

• 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: Insulin Resistance; Hypersensitivity; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

Participant Flow

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	20	26
COMPLETED	17	16
NOT COMPLETED	3	10

Baseline Characteristics

Arm/Group Title	African-American Women	Caucasian Women	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	18	17	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.3 (3.43)	21.6 (3.92)	21.0 (3.68)
Sex: Female, Male (Count of Participants)
Female	18 100%	17 100%	35 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	18 100%	0 0%	18 51.4%
White	0 0%	17 100%	17 48.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	18 100%	17 100%	35 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Insulin Sensitivity
Description	Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	15
Mean (95% Confidence Interval) [min ^ -1 / mIU / L]	-1.91	-5.63

2. Primary Outcome

Title	Change From Baseline in Flow-mediated Vasodilatation
Description	Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Data based on images. Some participants images could not be analyzed numerically.

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	5	9
Mean (95% Confidence Interval) [mm]	0.0503	-0.0210

3. Primary Outcome

Title	Change From Baseline in Carotid Intima Media Thickness
Description	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
Time Frame	baseline, 6 months

Outcome Measure Data

Analysis Population Description

Data based on images. Some participants images could not be analyzed numerically.

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	4	9
Mean (95% Confidence Interval) [mm]	-0.00008	0.00118

4. Secondary Outcome

Title	Change From Baseline in Acute Insulin Response to Glucose
Description	Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	17	15
Mean (95% Confidence Interval) [mIU* L^-1 * min]	-35.6	0.48

5. Secondary Outcome

Title	Change From Baseline in Glucose Effectiveness
Description	Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	15
Mean (95% Confidence Interval) [1000 * min ^ -1]	-0.0255	-0.0078

6. Secondary Outcome

Title	Change From Baseline in Disposition Index at 6 Months
Description	Modeled from FISVGTT--higher values indicate better glucose disposition
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	15
Mean (95% Confidence Interval) [AIRG * Si]	-911.73	-834.53

7. Secondary Outcome

Title	Change From Baseline in Fasting Insulin at 6 Months
Description	Higher fasting insulin values indicate an increased metabolic risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (95% Confidence Interval) [uIU/ mL]	1.66	1.45

8. Secondary Outcome

Title	Change From Baseline in Fasting Glucose at 6 Months
Description	Higher fasting glucose indicate an increased metabolic risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	15
Mean (95% Confidence Interval) [mg/dL]	-0.4	03

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (95% Confidence Interval) [mIU/mL * min]	760.6	1062.1

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (95% Confidence Interval) [mg/dL * min]	443.4	514.2

11. Secondary Outcome

Title	Change From Baseline in Systolic Blood Pressure at 6 Months
Description	Higher value indicates increased cardiovascular risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (95% Confidence Interval) [mmHg]	2.5	-1.4

12. Secondary Outcome

Title	Change From Baseline in HDL at 6 Months
Description	Lower values indicate increased cardiovascular risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (95% Confidence Interval) [mg/dL]	6.8	6.9

13. Secondary Outcome

Title	Change From Baseline in Body Mass Index in 6 Months
Description	Higher values indicate higher metabolic risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (95% Confidence Interval) [Kg/m2]	-0.32	0.39

14. Secondary Outcome

Title	Change in Diastolic Blood Pressure From Baseline to 6 Months
Description	Higher value indicates higher cardiovascular risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (95% Confidence Interval) [mmHg]	0.6	2.44

15. Secondary Outcome

Title	Change in LDL From Baseline to 6 Months
Description	Higher value indicates higher cardiovascular risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (95% Confidence Interval) [mg/dL]	13.4	17.1

16. Secondary Outcome

Title	Change in Triglycerides From Baseline to 6 Months
Description	Higher values indicate higher cardiovascular risk
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African-American Women	Caucasian Women
Arm/Group Description	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.	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.
Measure Participants	16	16
Mean (95% Confidence Interval) [mg/dL]	13.3	29.3

Adverse Events

Time Frame	Post-baseline follow-up phone call at 10 days
Adverse Event Reporting Description	Superficial venous thrombosis at IV site
Arm/Group Title	African-American Women		Caucasian Women
Arm/Group Description	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.		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.
All Cause Mortality
	African-American Women		Caucasian Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/26 (0%)
Serious Adverse Events
	African-American Women		Caucasian Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	African-American Women		Caucasian Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/26 (0%)

Limitations/Caveats

Small numbers of subjects analyzed. Some subjects did not have reportable carotid intima media thickness and flow mediated dilatation values.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.