Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453219
Status:
WITHDRAWN
Last Update Posted:
2013-10-30
First Post:
2007-03-26
Brief Title:
FHA Characterization of Metabolic Status Brain Circuitry and Stress-Reactivity
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Functional Hypothalamic Amenorrhea Characterization of Metabolic Status Brain Circuitry and Stress-reactivity
Status:
WITHDRAWN
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
prior to participant recruitment PI left Emory study stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Functional Hypothalamic Amenorrhea FHA the spontaneous cessation of the menstrual cycle for at least 6 months after menstrual cyclicity has been established is a common and reversible form of anovulation not due to discernible organic causes Whereas animal studies suggest an interaction of metabolic and psychosocial stress in the genesis of FHA the distinct central mechanisms in humans are not clear On a behavioral level FHA appears to depend on a complex interplay between individual stress susceptibility stressful life events and enduring metabolic challenge due to inappropriate attitudes towards eating and body image We will use a comparison group of ovulatory eumenorrheic women EW and a contrast group of lean women with polycystic ovary syndrome PCOS Although women with FHA and PCOS present with anovulation each condition differs markedly in pathobiology and health burden Contrasting women with FHA to those with PCOS will afford an opportunity to understand more about the interaction between metabolism stress and reproduction and to determine the extent to which differences between FHA and EW are attributable to reproductive compromise anovulation per se versus specific to the pathogenesis of FHA or PCOS We have used this approach to great advantage in the past to show that hypercortisolemia was confined to FHA and not PCOS Berga 1997 and that dysfunctional unrealistic attitudes and decreased coping skills were reported more often in FHA than in PCOS and more in PCOS than EW Further this approach of comparing 3 groups will allow us to improve therapeutic approaches for two principle causes of anovulatory infertility in women To accomplish this we will study women with FHA PCOS and normal ovulatory women The study will take place over 2 months and women will make 4-5 outpatient visits to the Clinical Integration Network Center and will have one overnight stay for frequent blood sampling
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