Trial Outcomes & Findings for Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women (NCT NCT01475513)

NCT ID: NCT01475513

Last Updated: 2018-08-08

Results Overview

Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 47 participants
• Primary outcome timeframe: Baseline, 6 months
• Results posted on: 2018-08-08

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	20	26
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	3	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	African-American Women n=18 Participants 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 n=17 Participants 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 n=35 Participants Total of all reporting groups
Age, Continuous	20.3 years STANDARD_DEVIATION 3.43 • n=5 Participants	21.6 years STANDARD_DEVIATION 3.92 • n=7 Participants	21.0 years STANDARD_DEVIATION 3.68 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	0 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	African-American Women n=16 Participants 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 n=15 Participants 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.
Change From Baseline in Insulin Sensitivity	-1.91 min ^ -1 / mIU / L Interval -5.63 to 1.8	-5.63 min ^ -1 / mIU / L Interval -9.47 to -1.8

PRIMARY outcome

Timeframe: Baseline, 6 months

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

Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk

Outcome measures

Measure	African-American Women n=5 Participants 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 n=9 Participants 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.
Change From Baseline in Flow-mediated Vasodilatation	0.0503 mm Interval -0.0905 to 0.19099	-0.0210 mm Interval -0.0868 to 0.04479

PRIMARY outcome

Timeframe: baseline, 6 months

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

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

Outcome measures

Measure	African-American Women n=4 Participants 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 n=9 Participants 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.
Change From Baseline in Carotid Intima Media Thickness	-0.00008 mm Interval -0.0054 to 0.00523	0.00118 mm Interval -0.0024 to 0.00472

SECONDARY outcome

Timeframe: Baseline, 6 months

Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response

Outcome measures

Measure	African-American Women n=17 Participants 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 n=15 Participants 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.
Change From Baseline in Acute Insulin Response to Glucose	-35.6 mIU* L^-1 * min Interval -251.0 to 179.77	0.48 mIU* L^-1 * min Interval -88.4 to 89.35

SECONDARY outcome

Timeframe: Baseline, 6 months

Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition

Outcome measures

Measure	African-American Women n=16 Participants 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 n=15 Participants 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.
Change From Baseline in Glucose Effectiveness	-0.0255 1000 * min ^ -1 Interval -0.045 to -0.0059	-0.0078 1000 * min ^ -1 Interval -0.0134 to -0.0022

SECONDARY outcome

Timeframe: Baseline, 6 months

Modeled from FISVGTT--higher values indicate better glucose disposition

Outcome measures

Measure	African-American Women n=16 Participants 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 n=15 Participants 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.
Change From Baseline in Disposition Index at 6 Months	-911.73 AIRG * Si Interval -2005.0 to 181.04	-834.53 AIRG * Si Interval -1963.0 to 294.09

SECONDARY outcome

Timeframe: Baseline, 6 months

Higher fasting insulin values indicate an increased metabolic risk

Outcome measures

Measure	African-American Women n=15 Participants 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 n=15 Participants 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.
Change From Baseline in Fasting Insulin at 6 Months	1.66 uIU/ mL Interval 0.568 to 2.743	1.45 uIU/ mL Interval 0.363 to 2.537

SECONDARY outcome

Timeframe: Baseline, 6 months

Higher fasting glucose indicate an increased metabolic risk

Outcome measures

Measure	African-American Women n=16 Participants 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 n=15 Participants 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.
Change From Baseline in Fasting Glucose at 6 Months	-0.4 mg/dL Interval -3.98 to 3.16	03 mg/dL Interval -3.46 to 3.92

SECONDARY outcome

Timeframe: Baselines, 6 months

Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk

Outcome measures

Measure	African-American Women n=15 Participants 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 n=15 Participants 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.
Change From Baseline in Areas-under-the-curve for Insulin at 6 Months	760.6 mIU/mL * min Interval -271.8 to 1733.1	1062.1 mIU/mL * min Interval 29.7 to 2094.5

SECONDARY outcome

Timeframe: Baseline, 6 months

Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk

Outcome measures

Measure	African-American Women n=15 Participants 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 n=15 Participants 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.
Change From Baseline in Areas-under-the-curve for Glucose	443.4 mg/dL * min Interval -623.7 to 1510.4	514.2 mg/dL * min Interval -552.8 to 1581.2

SECONDARY outcome

Timeframe: Baseline, 6 months

Higher value indicates increased cardiovascular risk

Outcome measures

Measure	African-American Women n=16 Participants 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 n=16 Participants 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.
Change From Baseline in Systolic Blood Pressure at 6 Months	2.5 mmHg Interval -2.11 to 7.05	-1.4 mmHg Interval -6.0 to 3.17

SECONDARY outcome

Timeframe: Baseline, 6 months

Lower values indicate increased cardiovascular risk

Outcome measures

Measure	African-American Women n=16 Participants 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 n=16 Participants 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.
Change From Baseline in HDL at 6 Months	6.8 mg/dL Interval 3.69 to 9.94	6.9 mg/dL Interval 2.96 to 10.79

SECONDARY outcome

Timeframe: Baseline, 6 months

Higher values indicate higher metabolic risk

Outcome measures

Measure	African-American Women n=16 Participants 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 n=16 Participants 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.
Change From Baseline in Body Mass Index in 6 Months	-0.32 Kg/m2 Interval -0.886 to 0.253	0.39 Kg/m2 Interval -0.669 to 1.456

SECONDARY outcome

Timeframe: Baseline, 6 months

Higher value indicates higher cardiovascular risk

Outcome measures

Measure	African-American Women n=16 Participants 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 n=16 Participants 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.
Change in Diastolic Blood Pressure From Baseline to 6 Months	0.6 mmHg Interval -2.64 to 3.89	2.44 mmHg Interval -0.83 to 5.7

SECONDARY outcome

Timeframe: Baseline, 6 months

Higher value indicates higher cardiovascular risk

Outcome measures

Measure	African-American Women n=16 Participants 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 n=16 Participants 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.
Change in LDL From Baseline to 6 Months	13.4 mg/dL Interval 5.71 to 21.04	17.1 mg/dL Interval 6.1 to 28.15

SECONDARY outcome

Timeframe: Baseline, 6 months

Higher values indicate higher cardiovascular risk

Outcome measures

Measure	African-American Women n=16 Participants 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 n=16 Participants 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.
Change in Triglycerides From Baseline to 6 Months	13.3 mg/dL Interval -3.78 to 30.28	29.3 mg/dL Interval 4.23 to 54.27

Adverse Events

African-American Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Caucasian Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kai Cheang

Virginia Commonwealth University

Phone: 8049863269

Email: kicheang@vcu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place