Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228930
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2005-09-27
Brief Title:
Tamoxifen Pharmacogenetics and Clinical Effects
Sponsor:
National Institute of General Medical Sciences NIGMS
Organization:
National Institute of General Medical Sciences NIGMS
Study Overview
Official Title:
A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects
Status:
COMPLETED
Status Verified Date:
2007-11
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:
The purpose of this research is to try to identify which women who take tamoxifen are likely to suffer from hot flashes or are more likely to have other side effects or benefits from the drug The researchers will do so by determining whether there are mutations that normally occur in human DNA that might influence the way individuals respond to medications
Detailed Description:
The study will test the following hypotheses
1 There is a relationship between genetically distinct metabolic profiles of tamoxifen and the frequency and severity of hot flashes in women on chronic tamoxifen therapy
2 Genetically distinct metabolic profiles for tamoxifen effect lipid profile bone turnover metabolites and bone mineral density and coagulation factors
3 Different genetic profiles of estrogen responsive genes influence the pharmacodynamic effects of tamoxifen in cardiovascular system
1 There is a relationship between genetically distinct metabolic profiles of tamoxifen and the frequency and severity of hot flashes in women on chronic tamoxifen therapy
2 Genetically distinct metabolic profiles for tamoxifen effect lipid profile bone turnover metabolites and bone mineral density and coagulation factors
3 Different genetic profiles of estrogen responsive genes influence the pharmacodynamic effects of tamoxifen in cardiovascular system
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 |
|---|---|---|---|
| U01GM061373-05 | NIH | None | httpsreporternihgovquickSearchU01GM061373-05 |