Tamoxifen Pharmacogenetics and Clinical Effects
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|ClinicalTrials.gov Identifier: NCT00228930|
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : September 25, 2008
|Condition or disease||Intervention/treatment|
|Breast Cancer||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.
|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|
|Actual Study Completion Date :||August 2007|
Drug: Tamoxifen (pharmacodynamic analysis)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|