Status:
COMPLETED
Testosterone Replacement in Older Men and Atherosclerosis Progression
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Hypogonadism
Atherosclerosis
Eligibility:
MALE
60+ years
Phase:
PHASE4
Brief Summary
As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of age or older, have low testosterone levels. It is known that short-term testosterone replacement is safe, ...
Detailed Description
Although short-term administration of testosterone in replacement doses is relatively safe, the risks of long-term testosterone administration in older men remain poorly understood. The two major area...
Eligibility Criteria
Inclusion
- Age 60 years or greater
- Hypogonadism, Testosterone 100-400 ng/dl or Free Testosterone \< 50 pg/ml
- Generally good health
- At least 8 years of primary school education
- Able to pass screening test for dementia
- Able to give informed consent
Exclusion
- Testosterone level \< 100 ng/dl (these individuals will be referred for evaluation of severe hypogonadism)
- Use of testosterone or other androgens \[dehydroepiandrosterone (DHEA), Androstenedione\] in last year
- Use of growth hormone in the last year
- Current alcohol of drug dependence \[Alcohol Use Disorders Identification Test (AUDIT) Score \> 8\]
- Diseases known to affect gonadal function
- Medications known to affect gonadal function eg. anticonvulsants, glucocorticoids such as prednisone
- Prostate cancer, breast cancer
- Any cancer that may limit life expectancy to less than 5 years
- Limiting neuromuscular, joint or bone disease
- History of stroke with residual neurologic deficit
- Neurologic condition that would impair cognitive function including:
- epilepsy, multiple sclerosis, human immunodeficiency virus (HIV), Parkinson's disease, stroke
- Psychiatric disorder in the last year meeting Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSMIV) Axis 1 criteria
- Use of psychotropic medicine for at least 6 months
- Dementia as assessed by (Telephone Interview for Cognitive Status modified score less than 31)
- Severe symptoms of benign prostatic hyperplasia (BPH) (American Urological Association symptom index score greater than 21)
- Prostate nodule or induration of digital rectal exam (DRE)
- Prostate specific antigen (PSA) greater than 4 unless participant has had a negative transrectal biopsy within last 3 months
- Limiting heart disease in including New York (NY) Class III or IV - congestive heart failure, unstable angina, or myocardial infarction (MI) in last 3 months
- Liver function tests \[aspartate aminotransferase (AST) and alanine aminotransferase(ALT)\] greater than 3 times the upper limit of the reference range
- Serum creatinine (Cr) greater than 2.5 mg/dl
- Hematocrit greater than 48%
- Hemoglobin (Hb)A1c greater than 9.0%
- Untreated thyroid disease
- Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg)
- Body mass index (BMI greater than 35 kg/m2)
- Untreated severe obstructive sleep apnea
- Development of electrocardiogram (EKG) changes consistent with myocardial ischemia or changes in blood pressure during cardiopulmonary exercise testing will be excluded from testing of muscle strength and physical function.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2012
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00287586
Start Date
September 1 2004
End Date
May 12 2012
Last Update
June 29 2017
Active Locations (3)
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1
Kronos Longevity Research Institute
Phoenix, Arizona, United States, 85016
2
Charles R. Drew University of Medicine and Science
Los Angeles, California, United States, 90059
3
Boston University / Boston Medical Center
Boston, Massachusetts, United States, 02118