Tamoxifen Pharmacogenetics and Clinical Effects
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects|
Whole Blood Serum Plasma
|Study Start Date:||September 2002|
|Study Completion Date:||August 2007|
Drug: Tamoxifen (pharmacodynamic analysis)
The study will test the following hypotheses.
- 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.
- Genetically distinct metabolic profiles for tamoxifen effect lipid profile, bone turnover metabolites and bone mineral density, and coagulation factors.
- Different genetic profiles of estrogen responsive genes influence the pharmacodynamic effects of tamoxifen in cardiovascular system.
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||David Flockhart, MD, PhD||Indiana University School of Medicine|