Trial Outcomes & Findings for Efficacy and Tolerability of an Intra-Nasal Testosterone Product (NCT NCT00975650)
NCT ID: NCT00975650
Last Updated: 2018-08-13
Results Overview
The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.
COMPLETED
PHASE2
57 participants
0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.
2018-08-13
Participant Flow
Participant milestones
| Measure |
Sequence 1
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days;
|
Sequence 2
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Sequence 3
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
Sequence 4
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
|---|---|---|---|---|
|
Period 1
STARTED
|
13
|
16
|
14
|
14
|
|
Period 1
COMPLETED
|
13
|
16
|
14
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
13
|
16
|
14
|
14
|
|
Period 2
COMPLETED
|
12
|
14
|
14
|
14
|
|
Period 2
NOT COMPLETED
|
1
|
2
|
0
|
0
|
|
Period 3
STARTED
|
12
|
14
|
14
|
14
|
|
Period 3
COMPLETED
|
12
|
14
|
14
|
14
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
12
|
14
|
14
|
14
|
|
Period 4
COMPLETED
|
12
|
14
|
14
|
14
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
Baseline characteristics by cohort
| Measure |
All Subjects
n=57 Participants
All Subjects who were dosed.
|
|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 12.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.
The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment B
n=55 Participants
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment C
n=52 Participants
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment D
n=54 Participants
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
|---|---|---|---|---|
|
Serum Testosterone Ln-Cmax
|
6.25 ng/dL
Standard Deviation 0.37
|
6.41 ng/dL
Standard Deviation 0.35
|
6.54 ng/dL
Standard Deviation 0.36
|
6.36 ng/dL
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment B
n=55 Participants
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment C
n=52 Participants
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment D
n=54 Participants
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
|---|---|---|---|---|
|
Serum Testosterone Ln-AUCt
|
8.80 ng.h/dL
Standard Deviation 0.26
|
8.90 ng.h/dL
Standard Deviation 0.27
|
8.95 ng.h/dL
Standard Deviation 0.29
|
9.09 ng.h/dL
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment B
n=55 Participants
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment C
n=52 Participants
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment D
n=54 Participants
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
|---|---|---|---|---|
|
Serum Testosterone Cavg
|
287.10 ng/dL
Standard Deviation 76.42
|
316.64 ng/dL
Standard Deviation 88.93
|
336.11 ng/dL
Standard Deviation 100.76
|
384.62 ng/dL
Standard Deviation 102.97
|
PRIMARY outcome
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment B
n=55 Participants
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment C
n=52 Participants
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment D
n=54 Participants
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
|---|---|---|---|---|
|
Serum Dihydrotestosterone Ln-Cmax
|
3.54 ng/dL
Standard Deviation 0.38
|
3.67 ng/dL
Standard Deviation 0.44
|
3.80 ng/dL
Standard Deviation 0.41
|
3.44 ng/dL
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment B
n=55 Participants
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment C
n=52 Participants
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment D
n=54 Participants
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
|---|---|---|---|---|
|
Serum Dihydrotestosterone Ln-AUCt
|
6.34 ng.h/dL
Standard Deviation 0.38
|
6.47 ng.h/dL
Standard Deviation 0.41
|
6.52 ng.h/dL
Standard Deviation 0.45
|
6.33 ng.h/dL
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: 0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.Population: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment B
n=55 Participants
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment C
n=52 Participants
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment D
n=54 Participants
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
|---|---|---|---|---|
|
Serum Dihydrotestosterone Cavg
|
25.24 ng/dL
Standard Deviation 8.51
|
28.97 ng/dL
Standard Deviation 11.41
|
30.79 ng/dL
Standard Deviation 12.50
|
24.69 ng/dL
Standard Deviation 8.46
|
PRIMARY outcome
Timeframe: Each period is 7 daysPopulation: Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.
The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment B
n=55 Participants
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment C
n=52 Participants
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment D
n=54 Participants
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
|---|---|---|---|---|
|
Percentage of Subjects With Cavg Within the Reference Range
Dihydrotestosterone
|
24 Participants
|
31 Participants
|
34 Participants
|
22 Participants
|
|
Percentage of Subjects With Cavg Within the Reference Range
Testosterone
|
19 Participants
|
27 Participants
|
27 Participants
|
42 Participants
|
Adverse Events
Treatment A
Treatment B
Treatment C
Treatment D
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=57 participants at risk
Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment B
n=56 participants at risk
Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment C
n=54 participants at risk
Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days
|
Treatment D
n=55 participants at risk
Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
1.8%
1/57
|
5.4%
3/56
|
0.00%
0/54
|
0.00%
0/55
|
|
Gastrointestinal disorders
Nausea
|
3.5%
2/57
|
0.00%
0/56
|
0.00%
0/54
|
1.8%
1/55
|
|
General disorders
Application Site Rash
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
3.6%
2/55
|
|
Nervous system disorders
Headache
|
1.8%
1/57
|
3.6%
2/56
|
0.00%
0/54
|
1.8%
1/55
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/57
|
1.8%
1/56
|
0.00%
0/54
|
3.6%
2/55
|
Additional Information
Dr. Nathan Bryson, Vice President, Scientific Affairs
Acerus Pharmaceuticals Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place