Trial Outcomes & Findings for Efficacy of an Intranasal Testosterone Product (NCT NCT01252745)
NCT ID: NCT01252745
Last Updated: 2018-05-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
24 hours
Results posted on
2018-05-23
Participant Flow
Participant milestones
| Measure |
10.0 mg Testosterone t.i.d.
TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
|
13.5 mg Testosterone b.i.d.
TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
|
11.25 mg Testosterone t.i.d.
TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of an Intranasal Testosterone Product
Baseline characteristics by cohort
| Measure |
10.0 mg Testosterone t.i.d.
n=8 Participants
TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
|
13.5 mg Testosterone b.i.d.
n=7 Participants
TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
|
11.25 mg Testosterone t.i.d.
n=7 Participants
TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.38 years
STANDARD_DEVIATION 12.55 • n=93 Participants
|
53.86 years
STANDARD_DEVIATION 11.04 • n=4 Participants
|
51.57 years
STANDARD_DEVIATION 9.90 • n=27 Participants
|
52.59 years
STANDARD_DEVIATION 10.78 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
10.0 mg Testosterone t.i.d.
n=8 Participants
TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
|
13.5 mg Testosterone b.i.d.
n=7 Participants
TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
|
11.25 mg Testosterone t.i.d.
n=7 Participants
TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
|
|---|---|---|---|
|
Cmax of Serum Testosterone
|
830 ng/dL
Standard Deviation 188
|
1050 ng/dL
Standard Deviation 463
|
883 ng/dL
Standard Deviation 346
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
10.0 mg Testosterone t.i.d.
n=8 Participants
TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
|
13.5 mg Testosterone b.i.d.
n=7 Participants
TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
|
11.25 mg Testosterone t.i.d.
n=7 Participants
TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
|
|---|---|---|---|
|
Cavg of Serum Testosterone
|
413 ng/dL
Standard Deviation 138
|
408 ng/dL
Standard Deviation 147
|
396 ng/dL
Standard Deviation 110
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
10.0 mg Testosterone t.i.d.
n=8 Participants
TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
|
13.5 mg Testosterone b.i.d.
n=7 Participants
TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
|
11.25 mg Testosterone t.i.d.
n=7 Participants
TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
|
|---|---|---|---|
|
AUC0-t of Serum Testosterone
|
9920.07 ng.h/dL
Standard Deviation 3300.65
|
9781.39 ng.h/dL
Standard Deviation 3532.43
|
9505.03 ng.h/dL
Standard Deviation 2650.59
|
Adverse Events
10.0 mg Testosterone t.i.d.
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
13.5 mg Testosterone b.i.d.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
11.25 mg Testosterone t.i.d.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10.0 mg Testosterone t.i.d.
n=8 participants at risk
TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
|
13.5 mg Testosterone b.i.d.
n=7 participants at risk
TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
|
11.25 mg Testosterone t.i.d.
n=7 participants at risk
TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 2 • 1 month
|
0.00%
0/7 • 1 month
|
0.00%
0/7 • 1 month
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
12.5%
1/8 • Number of events 1 • 1 month
|
0.00%
0/7 • 1 month
|
0.00%
0/7 • 1 month
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
12.5%
1/8 • Number of events 1 • 1 month
|
0.00%
0/7 • 1 month
|
0.00%
0/7 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/8 • 1 month
|
14.3%
1/7 • Number of events 1 • 1 month
|
0.00%
0/7 • 1 month
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • 1 month
|
14.3%
1/7 • Number of events 1 • 1 month
|
0.00%
0/7 • 1 month
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 1 • 1 month
|
0.00%
0/7 • 1 month
|
0.00%
0/7 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60