5-Alpha Reductase and Anabolic Effects of Testosterone
Completed · Phase 2 · Has a placebo group
Conditions studied: Male Hypogonadism, Muscle Atrophy, Sarcopenia, Benign Prostate Hypertrophy
In brief
The purpose of this study is to determine whether a higher-than-replacement dose of testosterone and finasteride can be combined to safely increase muscle strength in older men who have a low blood concentration of testosterone.
Key facts
- Study ID
- NCT00475501
- Run by
- VA Office of Research and Development
- People needed
- 60
- Starts
- 2007-01-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2018-10-11
Who can join
Age: 60 and older. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Age > 60 years males
- Primary care at the Malcolm Randall VA Medical Center in Gainesville, Florida.
- Consenting subjects who have a morning (between 6:00 AM and 10:00 AM) serum total testosterone 300 ng/dL or bioavailable testosterone concentration 70 ng/dL and no exclusion criteria will be randomized to receive either testosterone or placebo.
You may not qualify if…
- Subjects with cognitive impairment will be identified by the Mini-Cog test and excluded. The Mini-Cog has high sensitivity and specificity for cognitive impairment, and is not affected by level of education.
- We will also exclude subjects with receptive aphasia, or a contraindication to testosterone replacement (i.e., history of or active prostate or breast cancer, severe benign prostatic hyperplasia as assessed by elevated American Urologic Association Symptom Index (AUASI) score > 25), congestive heart failure (Class 3 or 4), sleep apnea syndrome, polycythemia (Hct > 55%), or prostate specific antigen (PSA) > 2.6 ng/mL) will be excluded.
- Obese subjects (BMI > 35) will also be excluded.
- Subjects currently receiving testosterone supplementation or subjects who have an allergy to testosterone will also be excluded.
- Subjects previously receiving testosterone replacement therapy must be off such medication for at least four weeks.
Where it is running
- North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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