Trial Outcomes & Findings for A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator (NCT NCT01464879)
NCT ID: NCT01464879
Last Updated: 2017-09-13
Results Overview
Descriptive statistics was used to present the outcome results.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Days 15-21, Days 22-28 & Days 29-35
Results posted on
2017-09-13
Participant Flow
The study was conducted at one study site in the US. Out of 78 subjects screened, 20 subjects were enrolled in the study.
Apart from having history of hypogonadism, the study subjects were required to present with one or more symptoms of testosterone deficiency (i.e. fatigue, decreased muscle mass, reduced libido, reduced sexual functioning of a non-mechanical nature). The study subjects needed to be in good health despite exhibiting hypogonadism.
Participant milestones
| Measure |
Testosterone Topical
Initially subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
Hand Application (2.50 mL)
|
20
|
|
Overall Study
Washout Period
|
20
|
|
Overall Study
Applicator Application (1.25 mL)
|
19
|
|
Overall Study
Applicator Application (2.50 mL)
|
18
|
|
Overall Study
Applicator Application (3.75 mL)
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Testosterone Topical
Initially subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Non-compliance
|
1
|
Baseline Characteristics
A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
Baseline characteristics by cohort
| Measure |
Testosterone Topical
n=20 Participants
Initially study subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, study subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.
|
|---|---|
|
Age, Continuous
|
52.1 Year
STANDARD_DEVIATION 8.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 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
|
2 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
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 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
|
20 subjects
n=99 Participants
|
|
Height
|
69.2 inch
STANDARD_DEVIATION 2.7 • n=99 Participants
|
|
Weight
|
203.7 lbs
STANDARD_DEVIATION 29.9 • n=99 Participants
|
|
Body Mass Index (BMI)
|
29.8 kg/m^2
STANDARD_DEVIATION 3.1 • n=99 Participants
|
PRIMARY outcome
Timeframe: Days 15-21, Days 22-28 & Days 29-35Population: Full Analysis Set (FAS) population was used for this analysis, which comprised of all subjects who had any available Pharmacokinetic (PK) data.
Descriptive statistics was used to present the outcome results.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.
|
16.7 percentage of subjects
|
50.0 percentage of subjects
|
77.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Days 1-7Population: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=20 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.
|
50 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicatorPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=19 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)
Testosterone
|
5768 ng*hr/dL
Standard Deviation 1228
|
7686 ng*hr/dL
Standard Deviation 2648
|
10295 ng*hr/dL
Standard Deviation 3764
|
|
Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)
DHT
|
688 ng*hr/dL
Standard Deviation 349
|
974 ng*hr/dL
Standard Deviation 674
|
1223 ng*hr/dL
Standard Deviation 666
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicatorPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=19 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)
Testosterone
|
3.77 hr
Interval 0.0 to 24.0
|
3.77 hr
Interval 1.75 to 7.77
|
3.77 hr
Interval 1.77 to 9.92
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)
DHT
|
3.75 hr
Interval 0.0 to 24.0
|
3.78 hr
Interval 0.0 to 7.77
|
3.86 hr
Interval 1.78 to 24.0
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicatorPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=19 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)
Testosterone
|
396 ng/dL
Standard Deviation 137
|
641 ng/dL
Standard Deviation 319
|
1024 ng/dL
Standard Deviation 700
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)
DHT
|
37.6 ng/dL
Standard Deviation 20.3
|
57.7 ng/dL
Standard Deviation 39.0
|
78.9 ng/dL
Standard Deviation 58.3
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicatorPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=19 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
Testosterone
|
240 ng/dL
Standard Deviation 51
|
320 ng/dL
Standard Deviation 110
|
429 ng/dL
Standard Deviation 157
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
DHT
|
28.7 ng/dL
Standard Deviation 14.5
|
40.6 ng/dL
Standard Deviation 28.2
|
51.0 ng/dL
Standard Deviation 27.7
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicatorPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=19 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)
Testosterone
|
173 ng/dL
Standard Deviation 47
|
213 ng/dL
Standard Deviation 69
|
250 ng/dL
Standard Deviation 116
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)
DHT
|
21.1 ng/dL
Standard Deviation 9.0
|
29.9 ng/dL
Standard Deviation 21.9
|
37.3 ng/dL
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicatorPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=19 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
n=18 Participants
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)
Testosterone
|
7.78 hr
Interval 0.0 to 24.0
|
10.81 hr
Interval 0.0 to 24.0
|
4.76 hr
Interval 0.0 to 24.0
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)
DHT
|
9.83 hr
Interval 0.0 to 11.8
|
11.0 hr
Interval 0.0 to 24.0
|
9.79 hr
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through handPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=20 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ
Testosterone
|
7809 ng*hr/dL
Standard Deviation 2609
|
—
|
—
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ
DHT
|
1143 ng*hr/dL
Standard Deviation 740
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through handPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=20 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Tmax
Testosterone
|
1.86 hr
Interval 0.0 to 11.8
|
—
|
—
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Tmax
DHT
|
1.86 hr
Interval 0.0 to 7.77
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through handPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=20 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Cmax
Testosterone
|
517 ng/dL
Standard Deviation 381
|
—
|
—
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Cmax
DHT
|
69.1 ng/dL
Standard Deviation 58.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through handPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=20 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
Testosterone
|
325 ng/dL
Standard Deviation 109
|
—
|
—
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg
DHT
|
47.6 ng/dL
Standard Deviation 30.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through handPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=20 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Cmin
Testosterone
|
234 ng/dL
Standard Deviation 62
|
—
|
—
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Cmin
DHT
|
35.4 ng/dL
Standard Deviation 19.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through handPopulation: FAS population was used for this analysis, which comprised of all subjects who had any available PK data.
Outcome measures
| Measure |
Testosterone 1.25 mL (Applicator)
n=20 Participants
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Tmin
Testosterone
|
8.84 hr
Interval 0.0 to 24.0
|
—
|
—
|
|
Pharmacokinetics of Total Testosterone and DHT Measuring Tmin
DHT
|
11.8 hr
Interval 0.0 to 24.0
|
—
|
—
|
Adverse Events
Testosterone 2.50 mL (Hand)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testosterone 1.25 mL (Applicator)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testosterone 2.50 mL (Applicator)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testosterone 3.75 mL (Applicator)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone 2.50 mL (Hand)
n=20 participants at risk
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 1.25 mL (Applicator)
n=20 participants at risk
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm everyday for seven days.
|
Testosterone 2.50 mL (Applicator)
n=20 participants at risk
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm everyday for seven days.
|
Testosterone 3.75 mL (Applicator)
n=20 participants at risk
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, everyday for seven days.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Overall Treatment Period (36 Days)
Adverse events with onset after start of the first IMP administration were considered treatment-emergent and are presented.
|
0.00%
0/20 • Overall Treatment Period (36 Days)
Adverse events with onset after start of the first IMP administration were considered treatment-emergent and are presented.
|
0.00%
0/20 • Overall Treatment Period (36 Days)
Adverse events with onset after start of the first IMP administration were considered treatment-emergent and are presented.
|
5.0%
1/20 • Overall Treatment Period (36 Days)
Adverse events with onset after start of the first IMP administration were considered treatment-emergent and are presented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is a restriction on joint publications prepared in collaboration between investigator and sponsor as Ferring reserves the right to be involved in this decision. In the event of any disagreement in the content of any publication both investigator's and Ferring´s opinion will be fairly and sufficiently represented in the publication.
- Publication restrictions are in place
Restriction type: OTHER