Cycled Testosterone Replacement Study
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone; Placebo
Intervention description: Weekly im injections of 100 mg testosterone enanthate.; Weekly IM injections of sesame oil.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: Male
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Low Normal Testosterone; Male; Aging

Summary:

      The purpose of this study is to determine whether testosterone (male hormone) therapy is
      effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing
      in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body
      composition, muscle metabolism, muscle strength, and bone metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Availability of transportation (i.e., subjects must be able to provide their own
             transportation to UTMB).

        Exclusion Criteria:

          -  Medications such as anticoagulants (Coumadin) and glucocorticoids.

          -  History of angina that occurs with exertion or at rest.

          -  History of myocardial infarction within the last 12 months.

          -  Failure to successfully complete an exercise stress test using the Bruce protocol.
             Subjects that demonstrate ≥ 0.1 mV horizontal or downsloping ST segment depression, a
             drop in systolic blood pressure of ≥ 10 mm Hg, and/or frequent or repetitive
             arrhythmias (defined as ≥ 10 PVC/min, or couplets) during the stress test will be
             excluded.

          -  LDL cholesterol above 200 mg/dL.

          -  History of prostatic cancer.

          -  Elevated prostate specific antigen (PSA) above 4.0 µg/L, or severe benign prostatic
             hypertrophy (BPH) by history (frequent urination, reduced stream).

          -  Serum total testosterone concentrations of greater than 500 ng/dL.

          -  Subjects who engage in high intensity, elite training on a regular basis.

          -  Major medical illness such as diabetes, chronic obstructive pulmonary disease, or
             sleep apnea.

          -  Recent history of smoking tobacco.

          -  Hematocrit greater than 51%.

          -  Morbidly obese older men (BMI > 35).

          -  Hypertension: Blood pressure on three consecutive measurements taken at one week
             intervals that has a systolic pressure ≥ 140 or a diastolic blood pressure ≥ 90.
             Subjects will be included if they are on two or less blood pressure medications and
             have a blood pressure below these criteria.

          -  History of hepatitis or a 3-fold elevation of liver function tests (Alk phos, ALT,
             AST).

          -  Bone related disorders such as osteoporosis or parathyroid disease.

          -  DEXA scans revealing lumbar spine T-scores of less than -2.5.

          -  Subjects currently taking anti-bone-resorptive agents such as bisphosphonates,
             parathyroid hormone, or calcitonin.