Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205504
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2005-09-13
Brief Title:
Oral Contraceptives in the Metabolic Syndrome
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Oral Contraceptives in the Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral contraceptives OCs are the most widely used method of reversible birth control However the long-term cardiovascular safety of the widely used low-dose OCs ethinyl-estradiol 50 mcg is still debated Although cardiovascular events are rare in young women whether they use OCs or not the risks of myocardial infarction and ischemic stroke are increased among users of OCs who have conventional cardiovascular risk factors such as use of tobacco diabetes or hypercholesterolemia However the risk of cardiovascular events in OC users with emerging cardiovascular risk factors such as obesity and the metabolic syndrome have not been investigated Recently the metabolic syndrome has been linked with the risk of cardiovascular disease The syndrome is a clustering of risk factors in a single individual and its underlying cause may be insulin resistance Whether the metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied This is a critical problem because the metabolic syndrome is prevalent in 24 of adults Until the cardiovascular risks in users of OC are clearly defined the appropriate use of OC with the least harm would not be possible
The investigators long-term goal is to understand the best way to prevent and treat cardiovascular disease in women The objective of this particular project is to obtain pilot data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and cardiovascular risks in women taking OCs The researchers hypothesize that women with metabolic syndrome and obese women will have worsened glucose metabolism and elevated cardiovascular risks associated with OC use when compared to normal weight women without the metabolic syndrome Results of this study will clarify the risk factors for cardiovascular events in women taking OCs and will serve as pilot data for a National Institutes of Health NIH proposal Once the cardiovascular risk factors of OC users are understood clinicians can make better informed decisions about contraceptive choices for their patients
The investigators long-term goal is to understand the best way to prevent and treat cardiovascular disease in women The objective of this particular project is to obtain pilot data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and cardiovascular risks in women taking OCs The researchers hypothesize that women with metabolic syndrome and obese women will have worsened glucose metabolism and elevated cardiovascular risks associated with OC use when compared to normal weight women without the metabolic syndrome Results of this study will clarify the risk factors for cardiovascular events in women taking OCs and will serve as pilot data for a National Institutes of Health NIH proposal Once the cardiovascular risk factors of OC users are understood clinicians can make better informed decisions about contraceptive choices for their patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None