HealthyPhase 2NCT00112151

TEAM: Testosterone Supplementation and Exercise in Elderly Men

A Phase 2 study testing LowT, Resistance Training and HighT in people with Healthy, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 60 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LowT, Resistance Training and HighT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 167 participants
Where: 1 siteUnited States
Study dates: Jan 2005to Nov 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Prostate/breast cancer
Unable to exercise safely
severe obesity (>34 body mass index [BMI])
Polycythemia
Diabetes
Use of drugs that could affect T levels

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Health Sciences Center
Denver, Colorado, 80262

Other trials in United States

About this study

Official title: Testosterone Supplementation and Exercise in Elderly Men

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.

Read the 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.

Conditions: Healthy
Being tested: LowT, Resistance Training, Placebo, HighT
Keywords: andropause, hypogonadism, AndroGel, exercise, PRT, Testosterone, T supplementation
Medical subject headings: Hypogonadism, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LowTDrug
Also called Androgel
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.
Resistance TrainingBehavioural
Also called PRT, Progressive resistance training
Weight training 45-60 minutes 3 times per week
PlaceboDrug
2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.
HighTDrug
Also called Androgel
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.

Study groups in NCT00112151
Study group	Role	What they receive
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 Receives: Drug: LowT; Behavioral: 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 Receives: 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 Receives: Behavioral: Resistance Training; Drug: 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 Receives: Drug: HighT
Placebo+Resistance Training	Active comparator	Placebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program Receives: Behavioral: Resistance Training; Drug: Placebo
Placebo+No Resistance Training	Placebo comparator	Placebo group applies two 2.5 gm placebo packets No exercise program Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 12 months

Secondary outcomes (5)

Upper Body Muscle Strength (1-RM, kg)
The maximal weight a participant could lift once (1-repetition maximum, 1-RM) was assessed at baseline and 12 months. The average of the difference from baseline in 4 upper-body 1-RM measures (bench press,incline press, overhead pull-down, and seated row) are represented.
Measured: Baseline and 12 months
Lower Body Muscle Strength (1-RM, kg)
The maximal weight a participant could lift once [1-repetition maximum, 1-RM] was assessed at baseline and 12 months. The average of the difference from baseline in 3 lower-body 1-RM measures (knee extension, knee flexion, and seated leg press)) are represented.
Measured: Baseline and 12 months
Power (Power Rig, Watts)
Leg extensor power was evaluated using a Nottingham leg extensor power rig (watts).
Measured: Baseline and 12 months
Fat Mass (kg)
Total change in Fat mass (kg) as evaluated by DXA
Measured: Baseline and 12 months
Fat Free Mass (kg)
Total change in Fat free mass (kg) as evaluated by DXA
Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Nov 2010

First posted30 May 2005 (estimated)
Study startJan 2005
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00112151
Sponsor's protocol ID: 02-1056
Other IDs: R01AG019339
Status last verified: Aug 2020
First submitted: 27 May 2005
Last updated: 2 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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. doi: 10.1093/geronj/45.6.m181.
PubMed 2229940
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.
PubMed 7552755
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.
PubMed 8601053
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.
PubMed 6602143
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.
PubMed 9224429
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.
PubMed 8684716

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testosterone Supplementation and Exercise in Elderly Men
ClinicalTrials.gov ID: NCT00112151
Acronym / sponsor ID: 02-1056
Conditions: Healthy
Keywords: andropause, hypogonadism, AndroGel, exercise, PRT, Testosterone, T supplementation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Jan 2005
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 30 May 2005 (estimated)
Results: Posted 20 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Please see link below for updated version of full protocol.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
LowT+Resistance Training	Experimental	Drug: LowT, Behavioral: Resistance TrainingLow 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
LowT+No Resistance training	Experimental	Drug: LowTLow 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
HighT+Resistance Training	Experimental	Behavioral: Resistance Training, Drug: HighTHigh 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
HighT+No Resistance Training	Experimental	Drug: HighTHigh Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml) No exercise program
Placebo+Resistance Training	Active comparator	Behavioral: Resistance Training, Drug: PlaceboPlacebo Group applies two 2.5 gm placebo packets 1 year standard Progressive Resistance Training(PRT) program
Placebo+No Resistance Training	Placebo comparator	Drug: PlaceboPlacebo group applies two 2.5 gm placebo packets No exercise program

Who may qualify

Ages: 60 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (9 listed)

Prostate/breast cancer
Unable to exercise safely
severe obesity (>34 body mass index [BMI])
Polycythemia
Diabetes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LowTAlso: AndrogelLow 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.	Drug	LowT+No Resistance training, LowT+Resistance Training
Resistance TrainingAlso: PRT, Progressive resistance trainingWeight training 45-60 minutes 3 times per week	Behavioural	HighT+Resistance Training, LowT+Resistance Training, Placebo+Resistance Training
Placebo2.5 gm gel packets applied once daily. Sham adjustments made during the first 12 weeks. Duration is 52 weeks.	Drug	Placebo+No Resistance Training, Placebo+Resistance Training
HighTAlso: AndrogelHigh 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.	Drug	HighT+No Resistance Training, HighT+Resistance Training

Primary outcome

Physical Function (CS-PFP Total Score)
Time frame: Baseline and 12 months
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.

5 secondary outcomes

Upper Body Muscle Strength (1-RM, kg)
Time frame: Baseline and 12 months
Lower Body Muscle Strength (1-RM, kg)
Time frame: Baseline and 12 months
Power (Power Rig, Watts)
Time frame: Baseline and 12 months
Fat Mass (kg)
Time frame: Baseline and 12 months
Fat Free Mass (kg)
Time frame: Baseline and 12 months

Results and safety

Results posted to the registry on 20 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LowT+Resistance Training	28	24
LowT+No Resistance Training	28	23
HighT+Resistance Training	28	25
HighT+No Resistance Training	27	24
Placebo+Resistance Training	28	22
Placebo+No Resistance Training	28	25

Primary outcome: Physical Function (CS-PFP Total Score)

Time frame: Baseline and 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo + No PRT n = 25	Placebo + PRT n = 22	Any T + No PRT n = 47	Any T + PRT n = 49
Value	3.1 (6.7)	3.6 (8.0)	0.8 (7.3)	3.3 (7.4)

Placebo + PRT vs Any T + PRT: p <0.025, Regression, Linear
Placebo + No PRT vs Any T + No PRT: p <0.025, Regression, Linear

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	30 of 47 (63.8%)	23 of 47 (48.9%)	Not reported
Lower-range T	33 of 47 (70.2%)	14 of 47 (29.8%)	Not reported
Higher-range T	38 of 49 (77.6%)	25 of 49 (51%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 2229940Schwartz 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.
Background: PubMed 7552755Porter 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.
Background: PubMed 8601053Jolles 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.
Background: PubMed 6602143Davidson 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.
Background: PubMed 9224429Vitiello 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.
Background: PubMed 8684716Myers 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert S. Schwartz, MD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LowT, Resistance Training and HighT in people with Healthy, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Function (CS-PFP Total Score) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00112151, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.