Trial Outcomes & Findings for Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents (NCT NCT02679274)
NCT ID: NCT02679274
Last Updated: 2019-02-18
Results Overview
Fat-free Mass (kg) calculated from total weight (kg) and percent body fat (%) obtained during bioelectric impedance analysis (BIA).
TERMINATED
EARLY_PHASE1
3 participants
0 to 10 Weeks
2019-02-18
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
Testosterone
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
Testosterone
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents
Baseline characteristics by cohort
| Measure |
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
83 years
n=99 Participants
|
65 years
n=107 Participants
|
74 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Weight
|
65 kg
n=99 Participants
|
96 kg
n=107 Participants
|
80 kg
n=206 Participants
|
|
Fat Mass
|
31 Percent Body Mass
n=99 Participants
|
51 Percent Body Mass
n=107 Participants
|
41 Percent Body Mass
n=206 Participants
|
|
BMI
|
27 kg/m^2
n=99 Participants
|
43 kg/m^2
n=107 Participants
|
35 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 to 10 WeeksFat-free Mass (kg) calculated from total weight (kg) and percent body fat (%) obtained during bioelectric impedance analysis (BIA).
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)
|
2.5 kg
|
0.8 kg
|
SECONDARY outcome
Timeframe: 0 to 10 WeeksMeasured using a handgrip dynamometer
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Change in Handgrip Strength
|
5.0 kg
|
-5.0 kg
|
SECONDARY outcome
Timeframe: 0 to 10 WeeksCollected using a manual muscle tester (MMT).
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Change in Knee Extension Strength (Seated)
|
5.9 kg
|
1.7 kg
|
SECONDARY outcome
Timeframe: 0 to 10 WeeksCollected using a manual muscle tester (MMT).
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Change in Hip Abduction Strength (Supine)
|
2.6 kg
|
0.9 kg
|
SECONDARY outcome
Timeframe: baselineDuring the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
|
10 seconds
|
0 seconds
|
SECONDARY outcome
Timeframe: 10 WeeksDuring the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
|
10 seconds
|
10 seconds
|
SECONDARY outcome
Timeframe: baselineDuring the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
|
0 seconds
|
0 seconds
|
SECONDARY outcome
Timeframe: 10 WeeksDuring the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks.
|
10 seconds
|
10 seconds
|
SECONDARY outcome
Timeframe: baselineDuring the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline
|
0 seconds
|
0 seconds
|
SECONDARY outcome
Timeframe: 10 WeeksDuring the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
|
2.6 seconds
|
0 seconds
|
SECONDARY outcome
Timeframe: 0 to 10 WeeksDuring the gait speed section of the Short Physical Performance Battery (SPPB) subjects are timed while walking a predefined 4 meter course. Data is shown as change in speed (meters/second) from baseline (0 weeks) to 10 weeks. A increase in speed indicates a better outcome.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Change in Gait Speed as Measured by Short Physical Performance Battery (SPPB).
|
0.48 meters/second
|
0.10 meters/second
|
SECONDARY outcome
Timeframe: baselineDuring the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their faster time.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Chair Raise as Measured by Short Physical Performance Battery (SPPB) at Baseline
|
2.02 seconds
|
1.08 seconds
|
SECONDARY outcome
Timeframe: 10 WeeksDuring the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their best time.
Outcome measures
| Measure |
Testosterone
n=1 Participants
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Testosterone: Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
|
Placebo
n=1 Participants
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Placebo: Intermittent intramuscular injections of saline (males and females).
|
|---|---|---|
|
Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks
|
1.01 seconds
|
1.08 seconds
|
Adverse Events
Placebo
Testosterone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place