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Before beginning any treatment, you will have a regular health examination that will include some routine blood tests. The research staff will measure your blood pressure, take your pulse, record your height and weight, and check your breasts, lungs, heart and abdomen. You will have a mammogram (if you have not had one done within the past 12 months) and a bone mineral density x-ray test, to measure the thickness of your bones (if you have not had one in the past year). If you are eligible and you choose to participate, you will read and sign a consent form that explains the ExCel research study in more detail. Then you will be randomly assigned to 1 of 2 treatment groups and will take 1 pill per day for 5 years. You will have 2 follow-up visits during the first year - at 6 and 12 months - and then an annual follow-up visit during years 2 through 5 for clinical evaluation. During these visits you will have routine blood tests and a mammogram. You will also be asked to complete some questionnaires at your follow-up appointments about your overall health and quality of life. During the study, your doctor will watch you closely to see if you have side effects from the study drugs or any other medications that you may be taking. |
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