drugset / Trial / NCT01769625

Changes in Biomarkers Using Prostaglandin Inhibitors

NCT01769625

RandomizedParallel-groupDouble-blindPrevention

Summary

This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease. The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.

Timeline

Start
2009-01
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Celecoxib Other / unclassified 400 mg
Subject Cholecalciferol Other / unclassified 400 iu
Subject Cholecalciferol Other / unclassified 2000 iu

Indications