Status:
COMPLETED
Cycled Testosterone Replacement Study
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Hypogonadism
Eligibility:
MALE
60-85 years
Phase:
PHASE1
Brief 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...
Detailed Description
Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing age regardless of their level of physical activity. A 12-yr longitudinal study in healthy sedentary older ...
Eligibility Criteria
Inclusion
- Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00957528
Start Date
January 1 2006
End Date
December 1 2008
Last Update
September 10 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Medical Branch
Galveston, Texas, United States, 77555