TEAM: Testosterone Supplementation and Exercise in Elderly Men

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00112151
First received: May 27, 2005
Last updated: October 10, 2012
Last verified: October 2012
  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: Progressive Resistance Training
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testosterone Supplementation and Exercise in Elderly Men

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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 ]

Enrollment: 167
Study Start Date: January 2005
Estimated Study Completion Date: August 2014
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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 Name: Androgel
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

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 Name: Androgel
Behavioral: Progressive Resistance Training
Weight training 45-60 minutes 3 times per week
Other Name: PRT
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

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 Name: Androgel
Active Comparator: Placebo+Progressive Resistance Training

Placebo Group applies two 2.5 gm placebo packets

1 year standard Progressive Resistance Training(PRT) program

Behavioral: Progressive Resistance Training
Weight training 45-60 minutes 3 times per week
Other Name: PRT
Drug: Placebo
2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
Placebo Comparator: Placebo+No Progressive Resistance Training

Placebo group applies two 2.5 gm placebo packets

No exercise program

Drug: Placebo
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.

Please see link below for updated version of full protocol.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Robert S. Schwartz, MD University of Colorado, Denver
  More Information

Additional Information:
Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00112151     History of Changes
Other Study ID Numbers: 02-1056, R01AG019339
Study First Received: May 27, 2005
Last Updated: October 10, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
andropause
hypogonadism
AndroGel
exercise
PRT
Testosterone
T supplementation

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

ClinicalTrials.gov processed this record on July 24, 2014