TEAM: Testosterone Supplementation and Exercise in Elderly Men - Full Text View

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:

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Robert S. Schwartz, MD

University of Colorado at Denver and Health Sciences Center

More Information

Publications:

Schwartz RS, Shuman WP, Bradbury VL, Cain KC, Fellingham GW, Beard JC, Kahn SE, Stratton JR, Cerqueira MD, Abrass IB. Body fat distribution in healthy young and older men. J Gerontol. 1990 Nov;45(6):M181-5.

Porter MM, Vandervoort AA, Lexell J. Aging of human muscle: structure, function and adaptability. Scand J Med Sci Sports. 1995 Jun;5(3):129-42. Review.

Jolles J, Verhey FR, Riedel WJ, Houx PJ. Cognitive impairment in elderly people. Predisposing factors and implications for experimental drug studies. Drugs Aging. 1995 Dec;7(6):459-79. Review.

Davidson JM, Chen JJ, Crapo L, Gray GD, Greenleaf WJ, Catania JA. Hormonal changes and sexual function in aging men. J Clin Endocrinol Metab. 1983 Jul;57(1):71-7.

Vitiello MV. Sleep disorders and aging: understanding the causes. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M189-91. Review. No abstract available.

Myers BL, Badia P. Changes in circadian rhythms and sleep quality with aging: mechanisms and interventions. Neurosci Biobehav Rev. 1995 Winter;19(4):553-71. Review. Erratum in: Neurosci Biobehav Rev 1996 Summer;20(2):I-IV.

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