Official Title: “Testosterone Supplementation and Exercise in Elderly Men”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Testosterone Gel
  • 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.
• Behavioral: Exercise - Progressive Resistance Training (PRT)
  • Weight training 45-60 minutes 3 times per week
• Drug: Placebo Gel
  • 2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: LD/PRT
  • 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 PRT program
• Experimental: LD
  • 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
• Experimental: HD/PRT
  • 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 PRT program
• Experimental: HD
  • 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
• Active Comparator: P/PRT
  • Placebo Group applies two 2.5 gm placebo packets 1 year standard PRT program
• Placebo Comparator: P
  • Placebo group applies two 2.5 gm placebo packets No exercise program

Primary Measures

• Muscle Strength & Power, Physical Function, Body Composition, Vascular Health
  • Time Frame: Baseline, 6 and 12 months
    Safety Issue?: No

Secondary Measures

• Blood chemistries
  • Time Frame: Baseline, 6 and 12 months
    Safety Issue?: Yes
• Transrectal ultrasound
  • Time Frame: Baseline and 12 months
    Safety Issue?: Yes
• Digital rectal exam
  • Time Frame: Baseline, 6 and 12 months
    Safety Issue?: Yes
• Obstructive sleep apnea
  • Time Frame: Baseline, 6 and 12 months
    Safety Issue?: Yes
• Maximal oxygen volume uptake
  • Time Frame: Baseline and 12 months
    Safety Issue?: Yes
• Benign prostatic hyperplasia
  • Time Frame: Baseline, 6 and 12 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Aging (NIA)

Overall Clinical Trial Officials and Contacts

Robert S. Schwartz, MD Principal Investigator University of Colorado at Denver and Health Sciences Center  

Overall Contact: Bethany Kelsey 720-848-6399 bethany.kelsey@ucdenver.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00112151

Study ID Number: AG0020

ClinicalTrials.gov Identifier: NCT00112151

Health Authority: United States: Federal Government