Trial Outcomes & Findings for Subcutaneous vs. Intramuscular Testosterone (NCT NCT03091348)
NCT ID: NCT03091348
Last Updated: 2019-10-08
Results Overview
Blood samples measured by Beckman assays and equipment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"
Results posted on
2019-10-08
Participant Flow
Participant milestones
| Measure |
SQ - IM
Subcutaneous testosterone injection followed by intramuscular testosterone injection
Testosterone: Testosterone cypionate injection
|
IM - SQ
Intramuscular testosterone injection followed by subcutaneous testosterone injection
Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
SQ - IM
Subcutaneous testosterone injection followed by intramuscular testosterone injection
Testosterone: Testosterone cypionate injection
|
IM - SQ
Intramuscular testosterone injection followed by subcutaneous testosterone injection
Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
loss to follow up
Baseline characteristics by cohort
| Measure |
SQ-IM
Subcutaneous testosterone injection followed by intramuscular testosterone injection
Testosterone: Testosterone cypionate injection
|
IM-SQ
n=1 Participants
Intramuscular testosterone injection followed by subcutaneous testosterone injection
Testosterone: Testosterone cypionate injection
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
44 years
STANDARD_DEVIATION 0 • n=7 Participants • loss to follow up
|
44 years
STANDARD_DEVIATION 0 • n=5 Participants • loss to follow up
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants • loss to follow up caused only 1 subject to be analyzed
|
0 Participants
n=7 Participants • loss to follow up caused only 1 subject to be analyzed
|
0 Participants
n=5 Participants • loss to follow up caused only 1 subject to be analyzed
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • loss to follow up caused only 1 subject to be analyzed
|
1 Participants
n=7 Participants • loss to follow up caused only 1 subject to be analyzed
|
1 Participants
n=5 Participants • loss to follow up caused only 1 subject to be analyzed
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants • loss to follow up
|
0 Participants
n=5 Participants • loss to follow up
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants • loss to follow up
|
0 Participants
n=5 Participants • loss to follow up
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants • loss to follow up
|
0 Participants
n=5 Participants • loss to follow up
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants • loss to follow up
|
0 Participants
n=5 Participants • loss to follow up
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=7 Participants • loss to follow up
|
1 Participants
n=5 Participants • loss to follow up
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants • loss to follow up
|
0 Participants
n=5 Participants • loss to follow up
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants • loss to follow up
|
0 Participants
n=5 Participants • loss to follow up
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Estradiol (E2)
|
—
|
24.5 pg/ml
n=7 Participants • loss to follow up
|
24.5 pg/ml
n=5 Participants • loss to follow up
|
|
Human Follicle Stimulating Hormone (hFSH)
|
—
|
3.5 miu/ml
n=7 Participants • loss to follow up
|
3.5 miu/ml
n=5 Participants • loss to follow up
|
|
Hemophagocytic lymphohistiocytosis(hLH)
|
—
|
3 miu/ml
n=7 Participants • loss to follow up
|
3 miu/ml
n=5 Participants • loss to follow up
|
|
Sex hormone binding globulin(SHBG)
|
—
|
27.3 nmol/l
n=7 Participants • loss to follow up
|
27.3 nmol/l
n=5 Participants • loss to follow up
|
|
Testosterone
|
—
|
317.1 ng/dl
n=7 Participants • loss to follow up
|
317.1 ng/dl
n=5 Participants • loss to follow up
|
PRIMARY outcome
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"Population: loss to follow up
Blood samples measured by Beckman assays and equipment.
Outcome measures
| Measure |
"SQ"
n=1 Participants
Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
|
"IM"
n=1 Participants
Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Change in Levels of Serum Total Testosterone Concentration
visit 2
|
NA ng/dl
design of the study is cross over, with only 1 subjects
|
1043.6 ng/dl
|
|
Change in Levels of Serum Total Testosterone Concentration
visit 3
|
NA ng/dl
design of the study is cross over, with only 1 subjects
|
785.7 ng/dl
|
|
Change in Levels of Serum Total Testosterone Concentration
visit 4
|
203.5 ng/dl
|
NA ng/dl
design of the study is cross over, with only 1 subjects
|
|
Change in Levels of Serum Total Testosterone Concentration
vist 5
|
1367.9 ng/dl
|
NA ng/dl
design of the study is cross over, with only 1 subjects
|
|
Change in Levels of Serum Total Testosterone Concentration
visit 6
|
980.8 ng/dl
|
NA ng/dl
design of the study is cross over, with only 1 subjects
|
|
Change in Levels of Serum Total Testosterone Concentration
visit 7
|
144.7 ng/dl
|
NA ng/dl
design of the study is cross over, with only 1 subjects
|
PRIMARY outcome
Timeframe: "Last visit ( Visit 7)"Population: loss to follow up
Blood samples measured by Beckman assays and equipment.
Outcome measures
| Measure |
"SQ"
n=1 Participants
Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
|
"IM"
n=1 Participants
Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Change in Levels of Serum Calculated Free T Concentration
|
0.84 ng/dL
|
14.74 ng/dL
|
SECONDARY outcome
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"Population: loss to follow up
Blood samples measured by Beckman assays and equipment.
Outcome measures
| Measure |
"SQ"
n=1 Participants
Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
|
"IM"
n=1 Participants
Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Change in Levels of Serum Estradiol
visit 2
|
NA pg/mL
cross over study design
|
70.03 pg/mL
|
|
Change in Levels of Serum Estradiol
visit 3
|
NA pg/mL
cross over study design
|
52.00 pg/mL
|
|
Change in Levels of Serum Estradiol
visit 4
|
30.06 pg/mL
|
NA pg/mL
cross over study design
|
|
Change in Levels of Serum Estradiol
visit 5
|
45.12 pg/mL
|
NA pg/mL
cross over study design
|
|
Change in Levels of Serum Estradiol
visit 6
|
64.74 pg/mL
|
NA pg/mL
cross over study design
|
|
Change in Levels of Serum Estradiol
visit 7
|
25.99 pg/mL
|
NA pg/mL
cross over study design
|
SECONDARY outcome
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"Population: loss to follow up
Blood samples measured by Beckman assays and equipment.
Outcome measures
| Measure |
"SQ"
n=1 Participants
Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
|
"IM"
n=1 Participants
Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Change in Levels of Serum LH
visit 4
|
0.2 miu/ml
|
NA miu/ml
cross over study design
|
|
Change in Levels of Serum LH
visit 5
|
0.04 miu/ml
|
NA miu/ml
cross over study design
|
|
Change in Levels of Serum LH
visit 2
|
NA miu/ml
cross over study design
|
0.4 miu/ml
|
|
Change in Levels of Serum LH
visit 3
|
NA miu/ml
cross over study design
|
0.3 miu/ml
|
|
Change in Levels of Serum LH
visit 6
|
0.1 miu/ml
|
NA miu/ml
cross over study design
|
|
Change in Levels of Serum LH
visit 7
|
0.4 miu/ml
|
NA miu/ml
cross over study design
|
SECONDARY outcome
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"Population: loss to follow up
Blood samples measured by Beckman assays and equipment.
Outcome measures
| Measure |
"SQ"
n=1 Participants
Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
|
"IM"
n=1 Participants
Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Change in Levels of Serum FSH
visit 2
|
NA miu/ml
cross over study design
|
1.3 miu/ml
|
|
Change in Levels of Serum FSH
visit 3
|
NA miu/ml
cross over study design
|
0.4 miu/ml
|
|
Change in Levels of Serum FSH
visit 4
|
0.2 miu/ml
|
NA miu/ml
cross over study design
|
|
Change in Levels of Serum FSH
visit 5
|
0.1 miu/ml
|
NA miu/ml
cross over study design
|
|
Change in Levels of Serum FSH
visit 6
|
0.05 miu/ml
|
NA miu/ml
cross over study design
|
|
Change in Levels of Serum FSH
visit 7
|
0.3 miu/ml
|
NA miu/ml
cross over study design
|
SECONDARY outcome
Timeframe: "Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"Population: loss to follow up
Blood samples measured by Beckman assays and equipment.
Outcome measures
| Measure |
"SQ"
n=1 Participants
Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
|
"IM"
n=1 Participants
Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Change in Levels of Serum SHBG
visit 2
|
NA nmol/l
cross over study design
|
25.5 nmol/l
|
|
Change in Levels of Serum SHBG
visit 3
|
NA nmol/l
cross over study design
|
22 nmol/l
|
|
Change in Levels of Serum SHBG
visit 4
|
27.8 nmol/l
|
NA nmol/l
cross over study design
|
|
Change in Levels of Serum SHBG
visit 5
|
24.8 nmol/l
|
NA nmol/l
cross over study design
|
|
Change in Levels of Serum SHBG
visit 6
|
22.9 nmol/l
|
NA nmol/l
cross over study design
|
|
Change in Levels of Serum SHBG
visit 7
|
20.7 nmol/l
|
NA nmol/l
cross over study design
|
SECONDARY outcome
Timeframe: "Last visit (Visit 7)"Population: loss to follow up
Blood samples measured by Beckman assays and equipment.
Outcome measures
| Measure |
"SQ"
n=1 Participants
Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
|
"IM"
n=1 Participants
Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Change in Level of Serum PSA
|
0.25 ng/mL
|
0.02 ng/mL
|
SECONDARY outcome
Timeframe: "Last visit (Visit 7)"Population: loss to follow up
Blood samples measured by Quest assays and equipment.
Outcome measures
| Measure |
"SQ"
n=1 Participants
Subcutaneous testosterone injection Testosterone: Testosterone cypionate injection
|
"IM"
n=1 Participants
Intramuscular testosterone injection Testosterone: Testosterone cypionate injection
|
|---|---|---|
|
Change in Levels of Whole Blood Hematocrit
|
NA g/dL
insufficient number of participants with event/measures.
|
1.9 g/dL
|
SECONDARY outcome
Timeframe: after last vist #7Population: loss to follow up
Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale is 1-5 (strongly disagree to strongly agree) Lower scores are better
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after last vist #7Population: loss to follow up
Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale 0-35, from Mild to Severe Lower score is better
Outcome measures
Outcome data not reported
Adverse Events
SQ Testosterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IM Testosterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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