Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442689
Status:
COMPLETED
Last Update Posted:
2014-06-06
First Post:
2007-02-05
Brief Title:
Metabolic Syndrome in PCOS Precursors and Interventions
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Metabolic Syndrome in PCOS Precursors and Interventions
Status:
COMPLETED
Status Verified Date:
2014-05
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:
The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills OCPs compared with placebo in the treatment of women with PCOS We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk
Detailed Description:
Polycystic ovary syndrome PCOS is one of the most common conditions of young women and it is frequently associated with insulin resistance or metabolic syndrome MBS In addition affected women have significantly elevated mean low-density lipoprotein LDL levels and an increased prevalence of at risk LDL levels independent of obesity We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone LH with oral contraceptive pills OCPs compared with placebo on visceral adiposity circulating LDL levels insulin secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests FSIGT and oral glucose tolerance tests OGTT resting energy expenditure and maximal aerobic capacity measurement
Note Originally there were 2 additional study arm Metformin only and Metformin Flutamide These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints
Note Originally there were 2 additional study arm Metformin only and Metformin Flutamide These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK073411 | NIH | None | httpsreporternihgovquickSearchR01DK073411 |