Tamoxifen Pharmacogenetics and Clinical Effects
|ClinicalTrials.gov Identifier: NCT00228930|
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : September 25, 2008
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Tamoxifen (pharmacodynamic analysis)||Phase 4|
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.
|Study Type :||Observational|
|Actual Enrollment :||297 participants|
|Official Title:||A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects|
|Study Start Date :||September 2002|
|Study Completion Date :||August 2007|
Drug: Tamoxifen (pharmacodynamic analysis)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228930
|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|