Phase 2
Completed N=167
TEAM: Testosterone Supplementation and Exercise in Elderly Men
Healthy
Source: ClinicalTrials.gov NCT00112151 ↗
Enrolled (actual)
167
Serious AEs
70.6%
Results posted
Jan 2016
Primary outcomePrimary: Physical Function (CS-PFP Total Score) — 3.1; 3.6; 0.8; 3.3 units on a scale — p=<0.025
Summary
The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Function (CS-PFP Total Score) |
3.1; 3.6; 0.8; 3.3 | <0.025 sig |
| SECONDARY Upper Body Muscle Strength (1-RM, kg) |
4.3; 25.5; 7.8; 24.3 | <0.05 sig |
| SECONDARY Lower Body Muscle Strength (1-RM, kg) |
9.4; 27.0; 10.5; 28.0 | <0.05 sig |
| SECONDARY Power (Power Rig, Watts) |
4.5; 24.3; 0.8; 5.1 | <0.05 sig |
| SECONDARY Fat Mass (kg) |
0.7; -0.6; -1.0; -1.8 | <0.05 sig |
| SECONDARY Fat Free Mass (kg) |
0.1; 0.4; 1.0; 2.1 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Generally healthy, untrained men 60 years or older with low-normal testosterone levels (200-350ng/dL)
- Must reside in the Denver metro area
Exclusion Criteria
- Prostate/breast cancer
- Unable to exercise safely
- severe obesity (>34 body mass index [BMI])
- Polycythemia
- Diabetes
- Use of drugs that could affect T levels
- Cognitive dysfunction (MMSE less than 24)
- PSA above the age-adjusted normal level or AUA greater than 19
- Unable to pass stress test due to active CAD
Data sourced from ClinicalTrials.gov (NCT00112151). 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. Informational only — not medical advice.