Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000612
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
1999-10-27
Brief Title:
Soy Estrogen Alternative Study SEA
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:
2000-11
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 conduct a three-armed trial assessing the effect of soy phytoestrogens on menopausal complaints plasma lipids and lipoproteins vaginal bleeding and endometrial proliferation and health related quality of life
Detailed Description:
BACKGROUND
The results of many studies indicate that estrogen replacement therapy ERT reduces the risk of coronary heart disease CHD in postmenopausal women However less than 9 percent of these women choose to take ERT because of unwanted side effects and concerns about increased risk of cancer associated with ERT Therefore alternative therapies are needed
The isoflavonoids found in soy protein specifically genistein have many properties that may reduce the risk of coronary heart disease These include favorable effects on plasma lipids and coronary artery vasomotion Furthermore genistein is a tyrosine kinase TK inhibitor with inhibitory effects on thrombin activity and TK receptor-linked mitogens that may be associated with atherogenesis and neointimal formation after angioplasty
DESIGN NARRATIVE
Randomized double-blind placebo-controlled The women were randomized into one of three groups placebo conjugated equine estrogens or soy supplementation Primary endpoints were the impact on menopausal complaints such as hot flushes mood lability anxiety sleep disturbances effects on plasma lipids and lipoproteins including lipoprotein a effects on vaginal bleeding and endometrial proliferation changes in health-related quality of life Secondary endpoints included assessment of the impact of these interventions on the progression of carotid artery intimal medial wall thickening as assessed by B-mode ultrasonography bone density and bone turnover additional measures to monitor the compliance and safety of the intervention such as mammography anticipated or known side effects of hormone replacement therapy blood levels of genistein and clinical outcomes such as hospitalizations physician visits and symptoms The study ended in December 1998
The study was a subproject within a program project on coronary atherosclerosis in females primarily monkeys Dr Thomas B Clarkson was the PI The subproject dollars were estimated based on the CRISP dollars assigned to the study which were approximately 12 percent of the total program project dollars and were broken down as follows FY 1996 - 219254 FY 1997 - 217000 FY 1998 - 221000
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 results of many studies indicate that estrogen replacement therapy ERT reduces the risk of coronary heart disease CHD in postmenopausal women However less than 9 percent of these women choose to take ERT because of unwanted side effects and concerns about increased risk of cancer associated with ERT Therefore alternative therapies are needed
The isoflavonoids found in soy protein specifically genistein have many properties that may reduce the risk of coronary heart disease These include favorable effects on plasma lipids and coronary artery vasomotion Furthermore genistein is a tyrosine kinase TK inhibitor with inhibitory effects on thrombin activity and TK receptor-linked mitogens that may be associated with atherogenesis and neointimal formation after angioplasty
DESIGN NARRATIVE
Randomized double-blind placebo-controlled The women were randomized into one of three groups placebo conjugated equine estrogens or soy supplementation Primary endpoints were the impact on menopausal complaints such as hot flushes mood lability anxiety sleep disturbances effects on plasma lipids and lipoproteins including lipoprotein a effects on vaginal bleeding and endometrial proliferation changes in health-related quality of life Secondary endpoints included assessment of the impact of these interventions on the progression of carotid artery intimal medial wall thickening as assessed by B-mode ultrasonography bone density and bone turnover additional measures to monitor the compliance and safety of the intervention such as mammography anticipated or known side effects of hormone replacement therapy blood levels of genistein and clinical outcomes such as hospitalizations physician visits and symptoms The study ended in December 1998
The study was a subproject within a program project on coronary atherosclerosis in females primarily monkeys Dr Thomas B Clarkson was the PI The subproject dollars were estimated based on the CRISP dollars assigned to the study which were approximately 12 percent of the total program project dollars and were broken down as follows FY 1996 - 219254 FY 1997 - 217000 FY 1998 - 221000
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 |
|---|---|---|---|
| P01HL045666 | NIH | None | httpsreporternihgovquickSearchP01HL045666 |