Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005538
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
CHD Risk Behavioral Stress and Reproductive Hormones
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-08
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:
To determine the effects of behavioral stress and reproductive hormones on coronary heart disease CHD risk
Detailed Description:
DESIGN NARRATIVE
The behavioral study determines whether sex differences in stress responses may assist in explaining sex differences in CHD The ongoing research program has documented differences in psychological responses to acute stress between men and women and among women who vary in reproductive hormone status Building on these findings but also departing from previous efforts in strategy and design five studies are conducted Study 1 measures hemodynamic measures that underlie sex differences in cardiovascular responses to behavioral challenge Using longitudinal designs Study 2 compares womens stress responses prior to and three months after surgical menopause whereas Study 3 compares healthy womens stress responses prior to and three months after a temporary menopause due to the administration of a GnRH agonist In both studies some women after the second testing are administered estrogen replacement therapy and stress responses are again measured Thus Studies 2 and 3 also address the effects of estrogen replacement therapy on stress responses These studies gain significance from the fact that surgical menopause is associated with heightened risk for CHD whereas estrogen replacement therapy is associated with protection from CHD Study 4 describes the extent of sex differences in exposure to psychological stressors among men and women from two levels of social class Social class is included in the design because it is a risk factor for psychological stress and for CHD The final study tests the hypothesis that sex differences in stress responses are attenuated during a task within a feminine area of competency and accentuated during a task within a masculine area of competency
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The behavioral study determines whether sex differences in stress responses may assist in explaining sex differences in CHD The ongoing research program has documented differences in psychological responses to acute stress between men and women and among women who vary in reproductive hormone status Building on these findings but also departing from previous efforts in strategy and design five studies are conducted Study 1 measures hemodynamic measures that underlie sex differences in cardiovascular responses to behavioral challenge Using longitudinal designs Study 2 compares womens stress responses prior to and three months after surgical menopause whereas Study 3 compares healthy womens stress responses prior to and three months after a temporary menopause due to the administration of a GnRH agonist In both studies some women after the second testing are administered estrogen replacement therapy and stress responses are again measured Thus Studies 2 and 3 also address the effects of estrogen replacement therapy on stress responses These studies gain significance from the fact that surgical menopause is associated with heightened risk for CHD whereas estrogen replacement therapy is associated with protection from CHD Study 4 describes the extent of sex differences in exposure to psychological stressors among men and women from two levels of social class Social class is included in the design because it is a risk factor for psychological stress and for CHD The final study tests the hypothesis that sex differences in stress responses are attenuated during a task within a feminine area of competency and accentuated during a task within a masculine area of competency
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R37HL038712 | NIH | None | httpsreporternihgovquickSearchR37HL038712 |