Trial Outcomes & Findings for PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women (NCT NCT01364623)
NCT ID: NCT01364623
Last Updated: 2019-10-16
Results Overview
Area under the concentration time curve from time zero to the last measurable concentration time point (AUC0-t) for single dose and AUCtau shown for multiple dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing
Results posted on
2019-10-16
Participant Flow
Participant milestones
| Measure |
Low Dose TBS-2 Single Dose
Low dose testosterone nasal gel: Single dose administration
|
Medium Dose TBS-2 Single Dose
Medium dose testosterone nasal gel: Single dose administration
|
High Dose TBS-2 Single Dose
High dose testosterone nasal gel: single dose administration
|
Medium Dose TBS-2 Multiple-Dose
High dose testosterone nasal gel: multiple dose administration
|
|---|---|---|---|---|
|
Single Dose
STARTED
|
8
|
8
|
8
|
0
|
|
Single Dose
COMPLETED
|
8
|
8
|
8
|
0
|
|
Single Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Multiple Dose
STARTED
|
0
|
0
|
0
|
8
|
|
Multiple Dose
COMPLETED
|
0
|
0
|
0
|
8
|
|
Multiple Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
Baseline characteristics by cohort
| Measure |
Low Dose TBS-2
n=8 Participants
Low dose testosterone nasal gel: Single dose administration
|
Medium Dose TBS-2
n=8 Participants
Medium dose testosterone nasal gel: Single dose administration
Medium dose testosterone nasal gel: Multiple dose administration
|
High Dose TBS-2
n=8 Participants
High dose testosterone nasal gel: Single dose administration
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 5.73 • n=93 Participants
|
29.8 years
STANDARD_DEVIATION 4.43 • n=4 Participants
|
27.0 years
STANDARD_DEVIATION 6.57 • n=27 Participants
|
29.8 years
STANDARD_DEVIATION 5.86 • n=483 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
13 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
|
1 Participants
n=27 Participants
|
1 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
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
19 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
|
PRIMARY outcome
Timeframe: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosingArea under the concentration time curve from time zero to the last measurable concentration time point (AUC0-t) for single dose and AUCtau shown for multiple dose.
Outcome measures
| Measure |
Low Dose TBS-2 Single Dose
n=8 Participants
Low dose testosterone nasal gel: Single dose administration
|
Medium Dose TBS-2 Single Dose
n=8 Participants
Medium dose testosterone nasal gel: Single dose administration
|
High Dose TBS-2 Single Dose
n=8 Participants
High dose testosterone nasal gel: single dose administration
|
Medium Dose TBS-2 Multiple-Dose
n=8 Participants
Medium dose testosterone nasal gel: Multiple dose administration
|
|---|---|---|---|---|
|
Bioavailability (AUC0-t) of Total Testosterone Through Pharmacokinetic (PK) Profiles
|
223.981 ng*h/dL
Geometric Coefficient of Variation 39
|
328.002 ng*h/dL
Geometric Coefficient of Variation 35.8
|
834.391 ng*h/dL
Geometric Coefficient of Variation 49.7
|
553.325 ng*h/dL
Geometric Coefficient of Variation 41.4
|
PRIMARY outcome
Timeframe: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosingCmax - maximum concentration of total testosterone observed after dosing of TBS-2
Outcome measures
| Measure |
Low Dose TBS-2 Single Dose
n=8 Participants
Low dose testosterone nasal gel: Single dose administration
|
Medium Dose TBS-2 Single Dose
n=8 Participants
Medium dose testosterone nasal gel: Single dose administration
|
High Dose TBS-2 Single Dose
n=8 Participants
High dose testosterone nasal gel: single dose administration
|
Medium Dose TBS-2 Multiple-Dose
n=8 Participants
Medium dose testosterone nasal gel: Multiple dose administration
|
|---|---|---|---|---|
|
Bioavailability (Cmax) of Total Testosterone Through Pharmacokinetic Profiles
|
34.058 ng/dL
Geometric Coefficient of Variation 61.1
|
62.880 ng/dL
Geometric Coefficient of Variation 48.6
|
113.912 ng/dL
Geometric Coefficient of Variation 44.3
|
137.555 ng/dL
Geometric Coefficient of Variation 41.5
|
PRIMARY outcome
Timeframe: -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48h after Day 3 dosingOutcome measures
| Measure |
Low Dose TBS-2 Single Dose
n=8 Participants
Low dose testosterone nasal gel: Single dose administration
|
Medium Dose TBS-2 Single Dose
Medium dose testosterone nasal gel: Single dose administration
|
High Dose TBS-2 Single Dose
High dose testosterone nasal gel: single dose administration
|
Medium Dose TBS-2 Multiple-Dose
Medium dose testosterone nasal gel: Multiple dose administration
|
|---|---|---|---|---|
|
Medium Dose TBS-2 Multiple Dose Average Steady-state Concentration (Cavg) of Total Testosterone
|
0.944 ng/dL
Standard Deviation 0.408
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosingAUCt shown for single dose and AUCtau for multiple dose.
Outcome measures
| Measure |
Low Dose TBS-2 Single Dose
n=8 Participants
Low dose testosterone nasal gel: Single dose administration
|
Medium Dose TBS-2 Single Dose
n=8 Participants
Medium dose testosterone nasal gel: Single dose administration
|
High Dose TBS-2 Single Dose
n=8 Participants
High dose testosterone nasal gel: single dose administration
|
Medium Dose TBS-2 Multiple-Dose
n=8 Participants
Medium dose testosterone nasal gel: Multiple dose administration
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) for Dihydrotestosterone Following TBS-2
|
23.515 ng*h/dL
Geometric Coefficient of Variation 74.9
|
38.457 ng*h/dL
Geometric Coefficient of Variation 49.1
|
85.180 ng*h/dL
Geometric Coefficient of Variation 64.2
|
122.194 ng*h/dL
Geometric Coefficient of Variation 40.0
|
SECONDARY outcome
Timeframe: Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosingAUCt shown for single dose and AUCtau for multiple dose.
Outcome measures
| Measure |
Low Dose TBS-2 Single Dose
n=8 Participants
Low dose testosterone nasal gel: Single dose administration
|
Medium Dose TBS-2 Single Dose
n=8 Participants
Medium dose testosterone nasal gel: Single dose administration
|
High Dose TBS-2 Single Dose
n=8 Participants
High dose testosterone nasal gel: single dose administration
|
Medium Dose TBS-2 Multiple-Dose
n=8 Participants
Medium dose testosterone nasal gel: Multiple dose administration
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) for Estradiol Following TBS-2
|
105.763 pg*h/mL
Geometric Coefficient of Variation 118.7
|
75.97 pg*h/mL
Geometric Coefficient of Variation 82.2
|
43.97 pg*h/mL
Geometric Coefficient of Variation 197.9
|
400.264 pg*h/mL
Geometric Coefficient of Variation 54.0
|
Adverse Events
Low Dose TBS-2 Single Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Medium Dose TBS-2 Single Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
High Dose TBS-2 Single Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medium Dose TBS-2 Multiple Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose TBS-2 Single Dose
n=8 participants at risk
Low dose testosterone nasal gel: Single dose administration
|
Medium Dose TBS-2 Single Dose
n=8 participants at risk
Medium dose testosterone nasal gel: Single dose Administration
|
High Dose TBS-2 Single Dose
n=8 participants at risk
High dose testosterone nasal gel: single dose Administration
|
Medium Dose TBS-2 Multiple Dose
n=8 participants at risk
Medium dose testosterone nasal gel: multiple dose administration
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
General disorders
Catheter site erythema
|
12.5%
1/8 • 36 days
|
12.5%
1/8 • 36 days
|
12.5%
1/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
General disorders
Catheter site hemorrhage
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
25.0%
2/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
General disorders
Catheter site inflammation
|
25.0%
2/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
|
Infections and infestations
Vulvitis
|
12.5%
1/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
12.5%
1/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • 36 days
|
25.0%
2/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
12.5%
1/8 • 36 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
12.5%
1/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
0.00%
0/8 • 36 days
|
12.5%
1/8 • 36 days
|
Additional Information
Dr. Nathan Bryson, Vice President, Scientific Affairs
Acerus Pharmaceuticals Corporation
Phone: 1-416-679-0776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place