Phase 2
N=60
5-Alpha Reductase and Anabolic Effects of Testosterone
Male Hypogonadism · Muscle Atrophy · Sarcopenia · Benign Prostate Hypertrophy
Bottom Line
View on ClinicalTrials.gov: NCT00475501 ↗Enrolled (actual)
60
Serious AEs
10.0%
Results posted
Jul 2014
Primary outcome: Primary: 1 Repetition Maximum (1-RM) Strength Testing — 129.1; 109.4; 137.2; 118.8 kg — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Testosterone Enanthate (Drug); Finasteride (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1 Repetition Maximum (1-RM) Strength Testing |
129.1; 109.4; 137.2; 118.8; 9.192; -1.34 | <0.001 sig |
| SECONDARY Grip Strength kg |
17.0; 16.9; 18.2; 17.472; 1.66; -0.045 | 0.015 sig |
| SECONDARY Lumbar Spine L2-L4 Bone Mineral Density |
1.03; 1.02; 0.99; 1.07; 0.049; 0.002 | <0.001 sig |
| SECONDARY Geriatric Depression Scale |
2.38; 3.08; 4.93; 2.13; 1.80; 2.90 | 0.037 sig |
| SECONDARY 30 Minute Recall Portion of Rey Osterrieth Complex Figure (ROCF) Test |
12.42; 13.54; 12.82; 12.8; 16.68; 12.85 | 0.012 sig |
| SECONDARY Trail-Making Test, Part A |
37.59; 46.42; 36.65; 44.0; 38.5; 42.1 | 0.779 |
| SECONDARY Benton Judgment of Line Orientation Test |
24.54; 24.39; 25.88; 24.69; 25.00; 25.40 | 0.433 |
| SECONDARY Hematocrit |
42.6; 41.2; 42.0; 40.3; 3.6; 0.611 | <0.001 sig |
| SECONDARY Dietary Protein Intake |
0.97; 1.06; 0.99; 1.00; 0.87; 0.94 | 0.6219 |
| SECONDARY Transrectal Ultrasound Sizing of Prostate |
26.4; 29.7; 37.1; 36.9; 7.626; -1.984 | 0.0051 sig |
| SECONDARY Life Satisfaction |
13.83; 12.08; 11.35; 12.69; 12.67; 12.11 | 0.196 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00475501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.