Trial Outcomes & Findings for Oral Contraceptives in the Metabolic Syndrome (NCT NCT00205504)
NCT ID: NCT00205504
Last Updated: 2018-08-08
Results Overview
Insulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2018-08-08
Participant Flow
Although 46 completed informed consent, only 36 initiated the study. Among The participants who did not begin the study were lost to follow-up prior to beginning the protocol, were no shows, or withdrew from the study before beginning study procedures.
Participant milestones
| Measure |
Obese Women
Women with Body Mass Index (BMI) \>30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.
|
Lean Women
Women with Body Mass Index)BMI \<25 kg/m²
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Contraceptives in the Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Obese Women
n=21 Participants
Women with Body Mass Index (BMI) \>30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.
|
Lean Women
n=15 Participants
Women with Body Mass Index)BMI \<25 kg/m²
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=113 Participants
|
15 Participants
n=163 Participants
|
36 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Continuous
|
25.3 years
STANDARD_DEVIATION 6.9 • n=113 Participants
|
21.4 years
STANDARD_DEVIATION 2.3 • n=163 Participants
|
23.4 years
STANDARD_DEVIATION 5.8 • n=160 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=113 Participants
|
15 Participants
n=163 Participants
|
36 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=113 Participants
|
15 participants
n=163 Participants
|
36 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsInsulin sensitivity was assessed by frequent sampling intravenous glucose tolerance test (FSIVGTT).
Outcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women
6 months Insulin sensitivity
|
3.82 mIU/L
Standard Deviation 3.12
|
8.23 mIU/L
Standard Deviation 3.30
|
|
Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women
Baseline Insulin sensitivity
|
4.36 mIU/L
Standard Deviation 2.32
|
6.62 mIU/L
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThe lipid profile is assessed through blood sample analysis for low-density lipoprotein (LDL), Triglycerides and high-density lipoprotein (HDL).
Outcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women
Baseline LDL
|
95 mg/dL
Standard Deviation 18.4
|
84 mg/dL
Standard Deviation 24.3
|
|
Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women
6 months LDL
|
113 mg/dL
Standard Deviation 25.2
|
104 mg/dL
Standard Deviation 26.1
|
|
Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women
Baseline Triglycerides
|
72 mg/dL
Standard Deviation 50.3
|
72 mg/dL
Standard Deviation 52.0
|
|
Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women
6 months Triglycerides
|
83 mg/dL
Standard Deviation 51.1
|
106 mg/dL
Standard Deviation 52.9
|
|
Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women
Baseline HDL
|
51 mg/dL
Standard Deviation 10.7
|
53 mg/dL
Standard Deviation 10.0
|
|
Changes in Lipid Profile Compared Associated With OC Use Among (1) Obese Women and (2) Lean Women
6 months HDL
|
58 mg/dL
Standard Deviation 12.4
|
61 mg/dL
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsInflammatory markers are assessed through blood analysis for C-reactive protein (hs-CRP) and adiponectin.
Outcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline Hs-CRP
|
4908.76 ng/mL
Standard Deviation 5215.07
|
2050.77 ng/mL
Standard Deviation 4748.75
|
|
Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months Hs-CRP
|
6207.76 ng/mL
Standard Deviation 4566.8
|
2266.02 ng/mL
Standard Deviation 3443.3
|
|
Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline Adiponectin
|
17568.86 ng/mL
Standard Deviation 5680.86
|
21976.53 ng/mL
Standard Deviation 8322.05
|
|
Inflammatory Marker Changes, High Sensitive C-reactive Protein (Hs-CRP) and Adiponectin, Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months Adiponectin
|
18408.43 ng/mL
Standard Deviation 4934.39
|
22221.36 ng/mL
Standard Deviation 11160.97
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsOutcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline 16aE1
|
314.76 pg/mL
Standard Deviation 179.73
|
317.47 pg/mL
Standard Deviation 159.8
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months 16aE1
|
421.6 pg/mL
Standard Deviation 286.57
|
383.39 pg/mL
Standard Deviation 452.98
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline 2ME1
|
25.92 pg/mL
Standard Deviation 11.03
|
32.39 pg/mL
Standard Deviation 9.3
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months 2ME1
|
52.84 pg/mL
Standard Deviation 54.29
|
45.58 pg/mL
Standard Deviation 23.83
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline 4ME1
|
5.26 pg/mL
Standard Deviation 3.58
|
4.45 pg/mL
Standard Deviation 3.13
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months 4ME1
|
6.1 pg/mL
Standard Deviation 3.29
|
7.42 pg/mL
Standard Deviation 8.55
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline 2ME2
|
1.48 pg/mL
Standard Deviation 1.06
|
0.91 pg/mL
Standard Deviation 0.82
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months 2ME2
|
1.5 pg/mL
Standard Deviation 1.11
|
1.74 pg/mL
Standard Deviation 2.15
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline E1
|
217.23 pg/mL
Standard Deviation 170.88
|
245.99 pg/mL
Standard Deviation 128.41
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months E1
|
315.03 pg/mL
Standard Deviation 339.15
|
227.4 pg/mL
Standard Deviation 271.6
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline 4ME2
|
0.73 pg/mL
Standard Deviation 0.55
|
0.59 pg/mL
Standard Deviation 0.54
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months 4ME2
|
0.89 pg/mL
Standard Deviation 0.79
|
1.14 pg/mL
Standard Deviation 1.41
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline E2
|
34.11 pg/mL
Standard Deviation 15.61
|
36.796 pg/mL
Standard Deviation 17.28
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months E2
|
74.73 pg/mL
Standard Deviation 117.52
|
47.32 pg/mL
Standard Deviation 61.82
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline 2OHE1
|
101.07 pg/mL
Standard Deviation 126.04
|
85.62 pg/mL
Standard Deviation 48.08
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months 2OHE1
|
135.95 pg/mL
Standard Deviation 220.24
|
57.96 pg/mL
Standard Deviation 70.02
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline 2OHE2
|
9.81 pg/mL
Standard Deviation 5.85
|
8.01 pg/mL
Standard Deviation 3.62
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months 2OHE2
|
11.55 pg/mL
Standard Deviation 21.74
|
6.05 pg/mL
Standard Deviation 4.69
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline 4OHE1
|
33.78 pg/mL
Standard Deviation 16.52
|
33.98 pg/mL
Standard Deviation 25.86
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months 4OHE1
|
27.29 pg/mL
Standard Deviation 25.65
|
29.12 pg/mL
Standard Deviation 15.08
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline Total plasma
|
1068 pg/mL
Standard Deviation 472.78
|
1022.16 pg/mL
Standard Deviation 295.61
|
|
Changes in Estrogen Metabolites (Plasma) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months Total plasma
|
1342.21 pg/mL
Standard Deviation 1166.36
|
1007.89 pg/mL
Standard Deviation 977.81
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsWaist-to-hip ratio is assessed through calculated ratio of waist and hip circumference.
Outcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline Waist-Hip Ratio
|
0.79 ratio
Standard Deviation 0.059
|
0.73 ratio
Standard Deviation 0.027
|
|
Changes in Waist-to-Hip Ratio Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months Waist-Hip Ratio
|
0.81 ratio
Standard Deviation 0.057
|
0.73 ratio
Standard Deviation 0.057
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsInflammatory marker is assessed through blood analysis for Monocyte chemotactic protein-1 (MCP-1).
Outcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline MCP-1
|
209.56 pg/mL
Standard Deviation 125.92
|
156.14 pg/mL
Standard Deviation 36.29
|
|
Inflammatory Marker Changes (MCP-1) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months MCP-1
|
219.86 pg/mL
Standard Deviation 159.85
|
206.66 pg/mL
Standard Deviation 76.15
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsOutcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months Diastolic Blood Pressure
|
73.4 mm Hg
Standard Deviation 6.6
|
66.5 mm Hg
Standard Deviation 6.8
|
|
Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline Systolic Blood Pressure
|
121.1 mm Hg
Standard Deviation 3.2
|
105.7 mm Hg
Standard Deviation 8.6
|
|
Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months Systolic Blood Pressure
|
123.5 mm Hg
Standard Deviation 11.7
|
106.5 mm Hg
Standard Deviation 12.2
|
|
Changes in Blood Pressure Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline Diastolic Blood Pressure
|
74.4 mm Hg
Standard Deviation 1.8
|
68.0 mm Hg
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsBody Mass Index is a calculation of height and weight: kg/m²
Outcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline BMI
|
37.1 kg/m²
Standard Deviation 6.7
|
21.3 kg/m²
Standard Deviation 1.8
|
|
Changes in Body Mass Index (BMI) Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months BMI
|
37.6 kg/m²
Standard Deviation 4.7
|
21.4 kg/m²
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsOutcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline Waist circumference
|
100.0 cm
Standard Deviation 14.4
|
70.2 cm
Standard Deviation 4.1
|
|
Changes in Waist Circumference Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months Waist circumference
|
101.0 cm
Standard Deviation 10.5
|
70.9 cm
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThese inflammatory markers are assessed through blood analysis of Soluble Vascular Cell Adhesion Molecule (sVCAM) and soluble intercellular adhesion molecule (sICAM).
Outcome measures
| Measure |
Obese Women
n=14 Participants
Women with Body Mass Index (BMI) \>30 kg/m²
|
Lean Women
n=15 Participants
Women with Body Mass Index (BMI) \<25 kg/m²
|
|---|---|---|
|
Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline sVCAM
|
905 ng/mL
Standard Deviation 190.63
|
1139.6 ng/mL
Standard Deviation 159.57
|
|
Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months sVCAM
|
880.14 ng/mL
Standard Deviation 180.08
|
1003.29 ng/mL
Standard Deviation 256.62
|
|
Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
Baseline sICAM
|
163.34 ng/mL
Standard Deviation 50.44
|
182.11 ng/mL
Standard Deviation 91.17
|
|
Inflammatory Marker Changes, Soluble Vascular Cell Adhesion Molecule (sVCAM) and Soluble Intercellular Adhesion Molecule (sICAM), Associated With OC Use Compared Among (1) Obese Women and (2) Lean Women
6 months sICAM
|
163.2 ng/mL
Standard Deviation 27.71
|
160.21 ng/mL
Standard Deviation 74.88
|
Adverse Events
Obese Women
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Lean Women
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Obese Women
n=21 participants at risk
Women with Body Mass Index (BMI) \>30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.
|
Lean Women
n=15 participants at risk
Women with Body Mass Index)BMI \<25 kg/m²
|
|---|---|---|
|
Gastrointestinal disorders
Gallstones removal
|
4.8%
1/21
|
0.00%
0/15
|
Other adverse events
| Measure |
Obese Women
n=21 participants at risk
Women with Body Mass Index (BMI) \>30 kg/m².
Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use.
|
Lean Women
n=15 participants at risk
Women with Body Mass Index)BMI \<25 kg/m²
|
|---|---|---|
|
Injury, poisoning and procedural complications
Tiredness
|
0.00%
0/21
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Pain with venipuncture
|
0.00%
0/21
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Phlebitis due to catheter insertion
|
4.8%
1/21
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Dizziness due to Ortho Tricyclen
|
4.8%
1/21
|
0.00%
0/15
|
Additional Information
Kai Cheang, Principal Investigator
Virginia Commonwealth University
Phone: 804-828-9698
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place