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Trial Information
The Testosterone Trial - Can testosterone treatment improve unwanted effects of aging in older men?
The Testosterone Trial ("The T Trial for short") is a national study in older men who have low blood levels of testosterone. The main goal of The T Trial is to learn if using testosterone for one year will improve walking, sexual function, energy and memory. About 800 men, age 65 or older, in twelve regions across the United States will participate in The T Trial. Testosterone is the major male hormone. It plays an important role in muscle and bone strength, sex drive, energy level and memory. In many men, the amount of testosterone in the blood gradually decreases with age.
Research suggests that having low testosterone levels may cause some of the unwanted effects of aging. A blood test is the only way to learn what your testosterone level is.
If you join The T Trial you will get study-related health and medical screening exams at no cost to you. By participating in The T Trial you leave a legacy of knowledge for future generations. You will have the satisfaction of knowing tat you have taken part in important research that could make a difference for millions of older men.
Patient Inclusion Criteria:
Men greater than or equal to 65 years old
Total serum testosterone concentration < 275 and < 300 ng/dL at 7 -10 AM at each of two screening visits
Patient Exclusion Criteria:
Diagnosed prostate cancer, prostatic intraepithelial neoplasia (PIN), prostate nodule or, by the Prostate Cancer Risk Calculator, a >30% risk of having overall prostate cancer or >7% risk of having high grade prostate cancer
Severe lower urinary tract symptoms (score of = 19) by the International Prostate Symptom Score questionnaire
Hemoglobin <10 g/dL or >16.0 g/dL
Sleep apnea, diagnosed but untreated
Alcohol or substance abuse within the past year (based on self report)
Angina not controlled by treatment
NYHA class III or IV congestive heart failure
Myocardial infarction within the previous 3 months before entry
Stroke within the previous 3 months before entry
Severe pulmonary disease that precludes physical function tests
Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal; hemoglobin A1c >8.5%
Breast and lung cancer, and cancers that limit life expectancy to <5 years, or which require current therapy
Body mass index (BMI) >35 kg/m2
Mini Mental State Exam (MMSE) Score <24
Untreated moderate or severe depression as defined by a score of >14 on the PHQ-9 questionnaire, or other Axis I psychiatric disorders, such as schizophrenia.
Subjects with depression who have been stable for more than three months while taking an antidepressant medication are eligible.
Use of the following medications within the previous three months:
drugs that affect serum testosterone concentration
rhGH or megesterol acetate
introduction of anti-depressant medication
daily use of prednisone for more than two weeks
Antipsychotic medications for Axis I disorders
Opiate abuse within the past six months
Skin conditions at the testosterone gel application site, such as ulcer, erosion, lichenification, inflammation, or crust, or generalized skin conditions such as psoriasis or eczema that might affect testosterone absorption or tolerability of the testosterone gel
Known skin intolerance to alcohol or allergy to any of the ingredients of testosterone gel
Gilda Trandafirescu, Research Coordinator
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If you would like to learn more about participating in this study, please send an email message using the form below.
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