5-Alpha Reductase and Anabolic Effects of Testosterone

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborators: Endo Pharmaceuticals; Merck Sharp & Dohme Corp.
• Treatments: Anabolic Agents; Finasteride; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.