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TEAM: Testosterone Supplementation and Exercise in Elderly Men
This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), September 2009
First Received: May 27, 2005   Last Updated: September 29, 2009   History of Changes
Sponsor: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00112151
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Testosterone Gel
Behavioral: Exercise - Progressive Resistance Training (PRT)
Drug: Placebo Gel
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Testosterone Supplementation and Exercise in Elderly Men

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Muscle Strength & Power, Physical Function, Body Composition, Vascular Health [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood chemistries [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Transrectal ultrasound [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
  • Digital rectal exam [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Obstructive sleep apnea [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Maximal oxygen volume uptake [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]
  • Benign prostatic hyperplasia [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2005
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LD/PRT: 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 PRT program

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.
LD: 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

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.
HD/PRT: 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 PRT program

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
HD: 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

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.
P/PRT: Active Comparator

Placebo Group applies two 2.5 gm placebo packets

1 year standard PRT program

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.
P: Placebo Comparator

Placebo group applies two 2.5 gm placebo packets

No exercise program

Drug: Placebo Gel
2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.

Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112151

Contacts
Contact: Bethany Kelsey 720-848-6399 bethany.kelsey@ucdenver.edu
Contact: Suzanne Bell 720-848-6470 suzanne.bell@ucdenver.edu

Locations
United States, Colorado
University of Colorado Health Sciences Center Recruiting
Denver, Colorado, United States, 80262
Principal Investigator: Wendy Kohrt, PhD            
Sub-Investigator: Daniel Barry, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Robert S. Schwartz, MD University of Colorado at Denver and Health Sciences Center
  More Information

Publications:
Responsible Party: University of Colorado Health Sciences Center ( Robert S. Schwartz, MD, Medicine/Geriatrics Head )
Study ID Numbers: AG0020, AG19339
Study First Received: May 27, 2005
Last Updated: September 29, 2009
ClinicalTrials.gov Identifier: NCT00112151     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
andropause
hypogonadism
AndroGel
exercise
PRT
Testosterone
T supplementation

Additional relevant MeSH terms:
Anabolic Agents
Testosterone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions
Androgens
Testosterone 17 beta-cypionate

ClinicalTrials.gov processed this record on November 05, 2009