TEAM: Testosterone Supplementation and Exercise in Elderly Men | RxWiki

TEAM: Testosterone Supplementation and Exercise in Elderly Men

Overview[ - collapse ][ - ]

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	Healthy
Intervention	Drug: Testosterone Gel Behavioral: Progressive Resistance Training Drug: Placebo
Phase	Phase 2
Sponsor	University of Colorado, Denver
Responsible Party	University of Colorado, Denver
ClinicalTrials.gov Identifier	NCT00112151
First Received	May 27, 2005
Last Updated	October 10, 2012
Last verified	October 2012

Tracking Information[ + expand ][ + ]

First Received Date	May 27, 2005
Last Updated Date	October 10, 2012
Start Date	January 2005
Estimated Primary Completion Date	August 2014
Current Primary Outcome Measures	Muscle Strength & Power, Physical Function, Body Composition, Vascular Health [Time Frame: Baseline, 6 and 12 months] [Designated as safety issue: No]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	TEAM: Testosterone Supplementation and Exercise in Elderly Men
Official Title	Testosterone Supplementation and Exercise in Elderly Men
Brief 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.
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. Please see link below for updated version of full protocol.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Healthy
Intervention	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. Other Names: AndrogelBehavioral: Progressive Resistance Training Weight training 45-60 minutes 3 times per week Other Names: PRTDrug: Placebo 2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
Study Arm (s)	Experimental: LowT+Progressive Resistance Training 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 Experimental: LowT+No Progressive resistance training 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: HighT+Progressive Resistance Training 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 Experimental: HighT+No Progressive Resistance Training 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: Placebo+Progressive Resistance Training Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program Placebo Comparator: Placebo+No Progressive Resistance Training Placebo group applies two 2.5 gm placebo packets No exercise program

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	167
Estimated Completion Date	August 2014
Estimated Primary Completion Date	November 2010
Eligibility 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
Gender	Male
Ages	60 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00112151
Other Study ID Numbers	02-1056
Has Data Monitoring Committee	Yes
Information Provided By	University of Colorado, Denver
Study Sponsor	University of Colorado, Denver
Collaborators	National Institute on Aging (NIA)
Investigators	Principal Investigator: Robert S. Schwartz, MD University of Colorado, Denver
Verification Date	October 2012

Locations[ + expand ][ + ]