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Trial record 98 of 264 for:    Estrogen Resistance

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions Insulin Sensitivity
Cardiovascular Risk
Perimenopausal Disorder
Intervention Drug: Ortho Cyclen®
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title African-American Women Caucasian Women
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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
Arm/Group Title African-American Women Caucasian Women Total
Hide 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 Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 17 participants 35 participants
20.3  (3.43) 21.6  (3.92) 21.0  (3.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
18
 100.0%
17
 100.0%
35
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
 100.0%
0
   0.0%
18
  51.4%
White
0
   0.0%
17
 100.0%
17
  48.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 17 participants 35 participants
18
 100.0%
17
 100.0%
35
 100.0%
1.Primary Outcome
Title Change From Baseline in Insulin Sensitivity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
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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.

Overall Number of Participants Analyzed 16 15
Mean (95% Confidence Interval)
Unit of Measure: min ^ -1 / mIU / L
-1.91
(-5.63 to 1.80)
-5.63
(-9.47 to -1.80)
2.Primary Outcome
Title Change From Baseline in Flow-mediated Vasodilatation
Hide Description Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data based on images. Some participants images could not be analyzed numerically.
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 5 9
Mean (95% Confidence Interval)
Unit of Measure: mm
0.0503
(-0.0905 to 0.19099)
-0.0210
(-0.0868 to 0.04479)
3.Primary Outcome
Title Change From Baseline in Carotid Intima Media Thickness
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data based on images. Some participants images could not be analyzed numerically.
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 4 9
Mean (95% Confidence Interval)
Unit of Measure: mm
-0.00008
(-0.0054 to 0.00523)
0.00118
(-0.0024 to 0.00472)
4.Secondary Outcome
Title Change From Baseline in Acute Insulin Response to Glucose
Hide Description Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 17 15
Mean (95% Confidence Interval)
Unit of Measure: mIU* L^-1 * min
-35.6
(-251.0 to 179.77)
0.48
(-88.4 to 89.35)
5.Secondary Outcome
Title Change From Baseline in Glucose Effectiveness
Hide Description Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 15
Mean (95% Confidence Interval)
Unit of Measure: 1000 * min ^ -1
-0.0255
(-0.0450 to -0.0059)
-0.0078
(-0.0134 to -0.0022)
6.Secondary Outcome
Title Change From Baseline in Disposition Index at 6 Months
Hide Description Modeled from FISVGTT--higher values indicate better glucose disposition
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 15
Mean (95% Confidence Interval)
Unit of Measure: AIRG * Si
-911.73
(-2005 to 181.04)
-834.53
(-1963 to 294.09)
7.Secondary Outcome
Title Change From Baseline in Fasting Insulin at 6 Months
Hide Description Higher fasting insulin values indicate an increased metabolic risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: uIU/ mL
1.66
(0.568 to 2.743)
1.45
(0.363 to 2.537)
8.Secondary Outcome
Title Change From Baseline in Fasting Glucose at 6 Months
Hide Description Higher fasting glucose indicate an increased metabolic risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-0.4
(-3.98 to 3.16)
03
(-3.46 to 3.92)
9.Secondary Outcome
Title Change From Baseline in Areas-under-the-curve for Insulin at 6 Months
Hide Description Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Time Frame Baselines, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: mIU/mL * min
760.6
(-271.8 to 1733.1)
1062.1
(29.7 to 2094.5)
10.Secondary Outcome
Title Change From Baseline in Areas-under-the-curve for Glucose
Hide Description Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: mg/dL * min
443.4
(-623.7 to 1510.4)
514.2
(-552.8 to 1581.2)
11.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure at 6 Months
Hide Description Higher value indicates increased cardiovascular risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 16
Mean (95% Confidence Interval)
Unit of Measure: mmHg
2.5
(-2.11 to 7.05)
-1.4
(-6.00 to 3.17)
12.Secondary Outcome
Title Change From Baseline in HDL at 6 Months
Hide Description Lower values indicate increased cardiovascular risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 16
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
6.8
(3.69 to 9.94)
6.9
(2.96 to 10.79)
13.Secondary Outcome
Title Change From Baseline in Body Mass Index in 6 Months
Hide Description Higher values indicate higher metabolic risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 16
Mean (95% Confidence Interval)
Unit of Measure: Kg/m2
-0.32
(-0.886 to 0.253)
0.39
(-0.669 to 1.456)
14.Secondary Outcome
Title Change in Diastolic Blood Pressure From Baseline to 6 Months
Hide Description Higher value indicates higher cardiovascular risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 16
Mean (95% Confidence Interval)
Unit of Measure: mmHg
0.6
(-2.64 to 3.89)
2.44
(-0.83 to 5.70)
15.Secondary Outcome
Title Change in LDL From Baseline to 6 Months
Hide Description Higher value indicates higher cardiovascular risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 16
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
13.4
(5.71 to 21.04)
17.1
(6.10 to 28.15)
16.Secondary Outcome
Title Change in Triglycerides From Baseline to 6 Months
Hide Description Higher values indicate higher cardiovascular risk
Time Frame Baseline, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title African-American Women Caucasian Women
Hide 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.

Overall Number of Participants Analyzed 16 16
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
13.3
(-3.78 to 30.28)
29.3
(4.23 to 54.27)
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
Hide 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 (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/26 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
African-American Women Caucasian Women
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
African-American Women Caucasian Women
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/26 (0.00%) 
Small numbers of subjects analyzed. Some subjects did not have reportable carotid intima media thickness and flow mediated dilatation values.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kai Cheang
Organization: Virginia Commonwealth University
Phone: 8049863269
EMail: kicheang@vcu.edu
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01475513     History of Changes
Other Study ID Numbers: HM13769
First Submitted: November 8, 2011
First Posted: November 21, 2011
Results First Submitted: June 12, 2018
Results First Posted: July 10, 2018
Last Update Posted: August 8, 2018