NCT00112151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for phase_2 healthy

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2005

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

January 20, 2016

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

5.8 years

First QC Date

May 27, 2005

Results QC Date

November 4, 2015

Last Update Submit

August 19, 2020

Conditions

Healthy

Keywords

andropausehypogonadismAndroGelexercisePRTTestosteroneT supplementation

Outcome Measures

Primary Outcomes (1)

  • Physical Function (CS-PFP Total Score)

    Continuous-scale physical function performance test (CS-PFP) which comprises 15 everyday tasks requiring upper and lower body strength and flexibility, balance, coordination and endurance. The CS-PFP was developed to measure performance in higher functioning adults with minimal floor or ceiling effects, and is valid, reliable and sensitive to change. Total and domain scores are scaled from 0 to 100, with higher scores indicating better function.

    Baseline and 12 months

Secondary Outcomes (5)

  • Upper Body Muscle Strength (1-RM, kg)

    Baseline and 12 months

  • Lower Body Muscle Strength (1-RM, kg)

    Baseline and 12 months

  • Power (Power Rig, Watts)

    Baseline and 12 months

  • Fat Mass (kg)

    Baseline and 12 months

  • Fat Free Mass (kg)

    Baseline and 12 months

Study Arms (6)

LowT+Resistance Training

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 Progressive Resistance Training(PRT) program

Drug: LowTBehavioral: Resistance Training

LowT+No Resistance training

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: LowT

HighT+Resistance Training

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 Progressive Resistance Training(PRT) program

Behavioral: Resistance TrainingDrug: HighT

HighT+No Resistance Training

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: HighT

Placebo+Resistance Training

ACTIVE COMPARATOR

Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program

Behavioral: Resistance TrainingDrug: Placebo

Placebo+No Resistance Training

PLACEBO COMPARATOR

Placebo group applies two 2.5 gm placebo packets No exercise program

Drug: Placebo

Interventions

LowTDRUG

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)during the first 12 weeks. Total exposure duration is 52 weeks.

Also known as: Androgel
LowT+No Resistance trainingLowT+Resistance Training
Resistance TrainingBEHAVIORAL

Weight training 45-60 minutes 3 times per week

Also known as: PRT, Progressive resistance training
HighT+Resistance TrainingLowT+Resistance TrainingPlacebo+Resistance Training
PlaceboDRUG

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

Placebo+No Resistance TrainingPlacebo+Resistance Training
HighTDRUG

High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)during the first 12 weeks. Total exposure duration is 52 weeks.

Also known as: Androgel
HighT+No Resistance TrainingHighT+Resistance Training

Eligibility Criteria

Age60 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy, untrained men 60 years or older with low-normal testosterone levels (200-350ng/dL)
  • Must reside in the Denver metro area

You may not qualify if:

  • Prostate/breast cancer
  • Unable to exercise safely
  • severe obesity (\>34 body mass index \[BMI\])
  • Polycythemia
  • Diabetes
  • Use of drugs that could affect T levels
  • Cognitive dysfunction (MMSE less than 24)
  • PSA above the age-adjusted normal level or AUA greater than 19
  • Unable to pass stress test due to active CAD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Related Publications (6)

  • 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. doi: 10.1093/geronj/45.6.m181.

    PMID: 2229940BACKGROUND

  • 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. doi: 10.1111/j.1600-0838.1995.tb00026.x.

    PMID: 7552755BACKGROUND

  • 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. doi: 10.2165/00002512-199507060-00006.

    PMID: 8601053BACKGROUND

  • 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. doi: 10.1210/jcem-57-1-71.

    PMID: 6602143BACKGROUND

  • Vitiello MV. Sleep disorders and aging: understanding the causes. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M189-91. doi: 10.1093/gerona/52a.4.m189. No abstract available.

    PMID: 9224429BACKGROUND

  • 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. doi: 10.1016/0149-7634(95)00018-6.

    PMID: 8684716BACKGROUND

MeSH Terms

Conditions

HypogonadismMotor Activity

Interventions

TestosteroneResistance Training

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Robert S. Schwartz, Head, Division of Geriatric Medicine
Organization
Univeristy of Colorado at Denver
robert.schwartz@ucdenver.edu
303-724-1919

Study Officials

  • Robert S. Schwartz, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2005

First Posted

May 30, 2005

Study Start

January 1, 2005

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 2, 2020

Results First Posted

January 20, 2016

Record last verified: 2020-08

Locations

US(1)