Overview

This trial is active, not recruiting.

Condition healthy
Treatments testosterone gel, progressive resistance training, placebo
Phase phase 2
Sponsor University of Colorado, Denver
Collaborator National Institute on Aging (NIA)
Start date January 2005
End date November 2010
Trial size 167 participants
Trial identifier NCT00112151, 02-1056, R01AG019339

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) 1 year standard Progressive Resistance Training(PRT) program
testosterone gel Androgel
2.5 gm gel packets applied once daily, titrated during the first 12 weeks to a maximum of 10 gm per day, total duration 52 weeks.
progressive resistance training PRT
Weight training 45-60 minutes 3 times per week
placebo
2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
(Experimental)
Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml) No exercise program
testosterone gel Androgel
2.5 gm gel packets applied once daily, titrated during the first 12 weeks to a maximum of 10 gm per day, total duration 52 weeks.
(Experimental)
High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) 1 year standard Progressive Resistance Training(PRT) program
testosterone gel Androgel
2.5 gm gel packets applied once daily, titrated during the first 12 weeks to a maximum of 10 gm per day, total duration 52 weeks.
progressive resistance training PRT
Weight training 45-60 minutes 3 times per week
(Experimental)
High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) No exercise program
testosterone gel Androgel
2.5 gm gel packets applied once daily, titrated during the first 12 weeks to a maximum of 10 gm per day, total duration 52 weeks.
(Active Comparator)
Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program
progressive resistance training PRT
Weight training 45-60 minutes 3 times per week
placebo
2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
(Placebo Comparator)
Placebo group applies two 2.5 gm placebo packets No exercise program
placebo
2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.

Primary Outcomes

Measure
Muscle Strength & Power, Physical Function, Body Composition, Vascular Health
time frame: Baseline, 6 and 12 months

Secondary Outcomes

Measure
Blood chemistries
time frame: Baseline, 6 and 12 months
Transrectal ultrasound
time frame: Baseline and 12 months
Digital rectal exam
time frame: Baseline, 6 and 12 months
Obstructive sleep apnea
time frame: Baseline, 6 and 12 months
Maximal oxygen volume uptake
time frame: Baseline and 12 months
Benign prostatic hyperplasia
time frame: Baseline, 6 and 12 months

Eligibility Criteria

Male participants at least 60 years old.

Inclusion Criteria: - Generally healthy, untrained men over 60 years old 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 - Current smoker

Additional Information

Official title Testosterone Supplementation and Exercise in Elderly Men
Principal investigator Robert S. Schwartz, MD
Description Studies suggest that testosterone (T) replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory, and behavior, but the risks of chronic treatment, especially on the prostate, heart, and sleep quality, are not entirely clear. Therefore, it is most desirable to supplement into the lowest "effective" range in elderly men. However, the effects of lower than usual replacement T doses have not been well studied. Furthermore, the possible important interaction of exercise to enhance the positive effects of T supplementation, yet mitigate the possible side effects, has not been studied in older men. This one-year study will enroll 150 men with low-normal to slightly below normal serum total T levels. Participants will be randomized into one of 6 treatment groups to receive T supplementation (AndroGel) of 25mg/day, 50 mg/day or a placebo crossed with progressive resistance training (PRT) exercise 3 times a week versus none. At the end of the study, participants in the exercise-control group will be offered PRT. Please see link below for updated version of full protocol.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.