Phase 4
Completed N=46
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Insulin Sensitivity · Cardiovascular Disease · Perimenopausal Disorder
Source: ClinicalTrials.gov NCT01475513 ↗
Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Change From Baseline in Insulin Sensitivity — -1.91; -5.63 min ^ -1 / mIU / L
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Insulin Sensitivity |
-1.91; -5.63 | — |
| PRIMARY Change From Baseline in Flow-mediated Vasodilatation |
0.0503; -0.0210 | — |
| PRIMARY Change From Baseline in Carotid Intima Media Thickness |
-0.00008; 0.00118 | — |
| SECONDARY Change From Baseline in Acute Insulin Response to Glucose |
-35.6; 0.48 | — |
| SECONDARY Change From Baseline in Glucose Effectiveness |
-0.0255; -0.0078 | — |
| SECONDARY Change From Baseline in Disposition Index at 6 Months |
-911.73; -834.53 | — |
| SECONDARY Change From Baseline in Fasting Insulin at 6 Months |
1.66; 1.45 | — |
| SECONDARY Change From Baseline in Fasting Glucose at 6 Months |
-0.4; 03 | — |
| SECONDARY Change From Baseline in Areas-under-the-curve for Insulin at 6 Months |
760.6; 1062.1 | — |
| SECONDARY Change From Baseline in Areas-under-the-curve for Glucose |
443.4; 514.2 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at 6 Months |
2.5; -1.4 | — |
| SECONDARY Change From Baseline in HDL at 6 Months |
6.8; 6.9 | — |
| SECONDARY Change From Baseline in Body Mass Index in 6 Months |
-0.32; 0.39 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to 6 Months |
0.6; 2.44 | — |
| SECONDARY Change in LDL From Baseline to 6 Months |
13.4; 17.1 | — |
| SECONDARY Change in Triglycerides From Baseline to 6 Months |
13.3; 29.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01475513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.