Trial Outcomes & Findings for TEAM: Testosterone Supplementation and Exercise in Elderly Men (NCT NCT00112151)
NCT ID: NCT00112151
Last Updated: 2020-09-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
167 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2020-09-02
Participant Flow
Recruitment from January 2005 through August 2009 of community dwelling men \>=60 years of age in the Denver metropolitan area with active attempts to recruit men from all ethnic populations.
see eligibility criteria
Participant milestones
| Measure |
LowT+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
|
LowT+No 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
|
HighT+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
|
HighT+No 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
|
Placebo+Resistance Training
Placebo Group applies two 2.5 gm placebo packets
1 year standard Progressive Resistance Training(PRT) program
|
Placebo+No Resistance Training
Placebo group applies two 2.5 gm placebo packets
No exercise program
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
28
|
27
|
28
|
28
|
|
Overall Study
COMPLETED
|
24
|
23
|
25
|
24
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
3
|
3
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TEAM: Testosterone Supplementation and Exercise in Elderly Men
Baseline characteristics by cohort
| Measure |
LowT+Resistance Training
n=28 Participants
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
|
LowT+No Resistance Training
n=28 Participants
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
|
HighT+Resistance Training
n=28 Participants
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
|
HighT+No Resistance Training
n=27 Participants
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
|
Placebo+Resistance Training
n=28 Participants
Placebo Group applies two 2.5 gm placebo packets
1 year standard Progressive Resistance Training(PRT) program
|
Placebo+No Resistance Training
n=28 Participants
Placebo group applies two 2.5 gm placebo packets
No exercise program
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
12 Participants
n=30 Participants
|
82 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
85 Participants
n=3 Participants
|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
65.6 years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
64.3 years
STANDARD_DEVIATION 4.6 • n=206 Participants
|
65.3 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 4.5 • n=31 Participants
|
66.6 years
STANDARD_DEVIATION 5.4 • n=30 Participants
|
65.7 years
STANDARD_DEVIATION 5.5 • n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
167 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
28 participants
n=107 Participants
|
28 participants
n=206 Participants
|
27 participants
n=7 Participants
|
28 participants
n=31 Participants
|
28 participants
n=30 Participants
|
167 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsContinuous-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.
Outcome measures
| Measure |
Placebo + No PRT
n=25 Participants
Placebo gel; no exercise
|
Placebo + PRT
n=22 Participants
Placebo gel plus progressive resistance training
|
Any T + No PRT
n=47 Participants
T gel supplementation (lower or higher-range); no exercise
|
Any T + PRT
n=49 Participants
T gel supplementation (lower or higher-range) plus progressive resistance training
|
|---|---|---|---|---|
|
Physical Function (CS-PFP Total Score)
|
3.1 units on a scale
Standard Deviation 6.7
|
3.6 units on a scale
Standard Deviation 8.0
|
0.8 units on a scale
Standard Deviation 7.3
|
3.3 units on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe 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.
Outcome measures
| Measure |
Placebo + No PRT
n=25 Participants
Placebo gel; no exercise
|
Placebo + PRT
n=22 Participants
Placebo gel plus progressive resistance training
|
Any T + No PRT
n=47 Participants
T gel supplementation (lower or higher-range); no exercise
|
Any T + PRT
n=49 Participants
T gel supplementation (lower or higher-range) plus progressive resistance training
|
|---|---|---|---|---|
|
Upper Body Muscle Strength (1-RM, kg)
|
4.3 kg
Standard Deviation 7.7
|
25.5 kg
Standard Deviation 11.3
|
7.8 kg
Standard Deviation 6.9
|
24.3 kg
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe 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.
Outcome measures
| Measure |
Placebo + No PRT
n=25 Participants
Placebo gel; no exercise
|
Placebo + PRT
n=22 Participants
Placebo gel plus progressive resistance training
|
Any T + No PRT
n=47 Participants
T gel supplementation (lower or higher-range); no exercise
|
Any T + PRT
n=49 Participants
T gel supplementation (lower or higher-range) plus progressive resistance training
|
|---|---|---|---|---|
|
Lower Body Muscle Strength (1-RM, kg)
|
9.4 kg
Standard Deviation 11.6
|
27.0 kg
Standard Deviation 17.0
|
10.5 kg
Standard Deviation 10.9
|
28.0 kg
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsLeg extensor power was evaluated using a Nottingham leg extensor power rig (watts).
Outcome measures
| Measure |
Placebo + No PRT
n=25 Participants
Placebo gel; no exercise
|
Placebo + PRT
n=22 Participants
Placebo gel plus progressive resistance training
|
Any T + No PRT
n=47 Participants
T gel supplementation (lower or higher-range); no exercise
|
Any T + PRT
n=49 Participants
T gel supplementation (lower or higher-range) plus progressive resistance training
|
|---|---|---|---|---|
|
Power (Power Rig, Watts)
|
4.5 Watts
Standard Deviation 34.6
|
24.3 Watts
Standard Deviation 62.0
|
0.8 Watts
Standard Deviation 36.9
|
5.1 Watts
Standard Deviation 51.1
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsTotal change in Fat mass (kg) as evaluated by DXA
Outcome measures
| Measure |
Placebo + No PRT
n=25 Participants
Placebo gel; no exercise
|
Placebo + PRT
n=22 Participants
Placebo gel plus progressive resistance training
|
Any T + No PRT
n=47 Participants
T gel supplementation (lower or higher-range); no exercise
|
Any T + PRT
n=49 Participants
T gel supplementation (lower or higher-range) plus progressive resistance training
|
|---|---|---|---|---|
|
Fat Mass (kg)
|
0.7 kg
Standard Deviation 2.3
|
-0.6 kg
Standard Deviation 1.7
|
-1.0 kg
Standard Deviation 2.3
|
-1.8 kg
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsTotal change in Fat free mass (kg) as evaluated by DXA
Outcome measures
| Measure |
Placebo + No PRT
n=25 Participants
Placebo gel; no exercise
|
Placebo + PRT
n=22 Participants
Placebo gel plus progressive resistance training
|
Any T + No PRT
n=47 Participants
T gel supplementation (lower or higher-range); no exercise
|
Any T + PRT
n=49 Participants
T gel supplementation (lower or higher-range) plus progressive resistance training
|
|---|---|---|---|---|
|
Fat Free Mass (kg)
|
0.1 kg
Standard Deviation 1.7
|
0.4 kg
Standard Deviation 2.1
|
1.0 kg
Standard Deviation 2.2
|
2.1 kg
Standard Deviation 2.4
|
Adverse Events
Placebo
Serious events: 30 serious events
Other events: 23 other events
Deaths: 0 deaths
Lower-range T
Serious events: 33 serious events
Other events: 14 other events
Deaths: 0 deaths
Higher-range T
Serious events: 38 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo gel with or without progressive resistance training
|
Lower-range T
n=47 participants at risk
T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training
|
Higher-range T
n=49 participants at risk
T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training
|
|---|---|---|---|
|
Cardiac disorders
Total serious cardiovascular adverse events
|
21.3%
10/47 • Number of events 11 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
4.3%
2/47 • Number of events 3 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
2.0%
1/49 • Number of events 1 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
|
General disorders
Other noncardiovascular serious adverse events
|
42.6%
20/47 • Number of events 53 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
66.0%
31/47 • Number of events 55 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
75.5%
37/49 • Number of events 64 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo gel with or without progressive resistance training
|
Lower-range T
n=47 participants at risk
T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training
|
Higher-range T
n=49 participants at risk
T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Persistently elevated HCT >= 54%
|
6.4%
3/47 • Number of events 3 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
4.3%
2/47 • Number of events 4 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
22.4%
11/49 • Number of events 13 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
|
Renal and urinary disorders
Persistently elevated PSA
|
19.1%
9/47 • Number of events 14 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
10.6%
5/47 • Number of events 9 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
14.3%
7/49 • Number of events 13 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
|
Renal and urinary disorders
Elevated AUA
|
4.3%
2/47 • Number of events 2 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
2.1%
1/47 • Number of events 1 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
0.00%
0/49 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
|
Hepatobiliary disorders
Persistently elevated liver function tests
|
0.00%
0/47 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
0.00%
0/47 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
0.00%
0/49 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
|
Respiratory, thoracic and mediastinal disorders
Daytime somnolence/hypoxia
|
0.00%
0/47 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
0.00%
0/47 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
0.00%
0/49 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
|
General disorders
Other nonserious adverse events
|
19.1%
9/47 • Number of events 12 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
12.8%
6/47 • Number of events 6 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
14.3%
7/49 • Number of events 7 • 1 year
Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
|
Additional Information
Dr. Robert S. Schwartz, Head, Division of Geriatric Medicine
Univeristy of Colorado at Denver
Phone: 303-724-1919
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place