Testosterone Replacement in Older Men and Atherosclerosis Progression

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00287586
• Date of registration: 06/02/2006
• Primary sponsor: Boston University
• Public title: Testosterone Replacement in Older Men and Atherosclerosis Progression
• Scientific title: Effects of Testosterone Replacement on Atherosclerosis Progression in Older Men With Low Testosterone Levels
• Date of first enrolment: March 2003
• Target sample size: 360
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00287586
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Shalender Bhasin, MD
• Affiliation: Boston University / Boston Medical Center, Boston, MA

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- Testosterone level < 100 ng/dl (these individuals will be referred for evaluation of
severe hypogonadism)

- Use of testosterone or other androgens (DHEA, Androstenedione)in last year

- Use of growth hormone in the last year

- Current alcohol of drug dependence (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, HIV, Parkinson's disease, stroke

- Psychiatric disorder in the last year meeting 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 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 NY Class III or IV - congestive heart failure,
unstable angina, or myocardial infarction (MI) in last 3 months

- Liver function tests (AST and ALT) greater than 3 times the upper limit of the
reference range

- Serum 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 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.



Age minimum: 60 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Atherosclerosis

Hypogonadism

Intervention(s)

Drug: Testosterone Gel (Androgel)

Primary Outcome(s)

Atherosclerosis progression as assessed by Cardiac CT and Carotid IMT [Time Frame: Three years]

Secondary Outcome(s)

Changes in Biomarkers of Inflammation [Time Frame: Three years]

Changes in Blood Pressure [Time Frame: Three years]

Changes in Cognitive Function [Time Frame: Three years]

Changes in Lipid Profiles [Time Frame: Three years]

Changes in Muscle Strength [Time Frame: Three years]

Changes in Physical Function [Time Frame: Three years]

Secondary ID(s)

H-24192

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Solvay Pharmaceuticals