Trial Outcomes & Findings for Efficacy, Pharmacokinetics and Safety of Testosterone (NCT NCT01370369)
NCT ID: NCT01370369
Last Updated: 2017-09-13
Results Overview
Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From Baseline to Day 43
Results posted on
2017-09-13
Participant Flow
The study was conducted at one study site in the US. Out of 42 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 low testosterone (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
For single dose pharmacokinetics (PKs), a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the shoulder/upper arm.
After the last 24 hour PK sampling from the shoulder/upper arm, three ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (one stroke, two strokes and three strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments.
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|---|---|
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Overall Study
STARTED
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20
|
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Overall Study
COMPLETED
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20
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Pharmacokinetics and Safety of Testosterone
Baseline characteristics by cohort
| Measure |
Testosterone Topical
n=20 Participants
For single dose PKs, a single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the inner thigh followed by a 7-day washout period. After this washout period, the second single application of 2.50 mL (two strokes) of the testosterone gel 2% was applied to the abdomen followed by another 7-day washout period. After this washout period, the third single application of 2.50 mL (2 strokes) of the testosterone gel 2% was applied to the shoulder/upper arm.
After the last 24 hour PK sampling from the shoulder/upper arm, 3 ascending doses of testosterone gel 2%, 1.25, 2.50 and 3.75 mL (1 stroke, 2 strokes and 3 strokes, respectively), were sequentially applied once daily for 10 consecutive days to the shoulder/upper arm. Steady-state PK evaluations were performed starting on the morning of the last administered dose. There was no washout between each of the 10-day treatments.
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|---|---|
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Age, Continuous
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47.9 year
STANDARD_DEVIATION 9.9 • n=5 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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|
Body Mass Index (BMI)
|
28.3 Kg/m^2
STANDARD_DEVIATION 2.3 • n=5 Participants
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Height
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69.7 Inch
STANDARD_DEVIATION 3.2 • n=5 Participants
|
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Weight
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196.2 lbs
STANDARD_DEVIATION 23.3 • n=5 Participants
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PRIMARY outcome
Timeframe: From Baseline to Day 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
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|---|---|---|---|
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Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.
Cave
|
73.7 percentage of subjects
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77.7 percentage of subjects
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75.0 percentage of subjects
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|
Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.
Cmin
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20.0 percentage of subjects
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40.0 percentage of subjects
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55.0 percentage of subjects
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
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|---|---|---|---|
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Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.
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519 ng/dL
Standard Deviation 171
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451 ng/dL
Standard Deviation 157
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926 ng/dL
Standard Deviation 737
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
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|---|---|---|---|
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Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.
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24.0 hour
Interval 0.0 to 24.8
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9.0 hour
Interval 2.0 to 24.0
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11.0 hour
Interval 4.0 to 24.7
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 hr.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=19 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
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|---|---|---|---|
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Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.
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9472 ng*hour/dL
Standard Deviation 2306
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8918 ng*hour/dL
Standard Deviation 2924
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13368 ng*hour/dL
Standard Deviation 7163
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
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|---|---|---|---|
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Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
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586 ng/dL
Standard Deviation 290
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907 ng/dL
Standard Deviation 783
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1258 ng/dL
Standard Deviation 774
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
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|---|---|---|---|
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Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
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6.0 hour
Interval 0.0 to 24.0
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4.0 hour
Interval 0.0 to 24.9
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6.0 hour
Interval 0.0 to 24.0
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=19 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=18 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
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|---|---|---|---|
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Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
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9229 ng*hour/dL
Standard Deviation 2946
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12148 ng*hour/dL
Standard Deviation 6300
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17625 ng*hour/dL
Standard Deviation 9250
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
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|---|---|---|---|
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Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
|
134 pg/mL
Standard Deviation 90
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229 pg/mL
Standard Deviation 273
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382 pg/mL
Standard Deviation 342
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
|---|---|---|---|
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Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
|
6.0 hour
Interval 0.0 to 24.3
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7.0 hour
Interval 0.0 to 24.9
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6.0 hour
Interval 0.0 to 24.0
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SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=18 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=14 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=17 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
|---|---|---|---|
|
Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
|
1765 pg*hour/mL
Standard Deviation 781
|
2655 pg*hour/mL
Standard Deviation 2078
|
4663 pg*hour/mL
Standard Deviation 3517
|
SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
|---|---|---|---|
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Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
|
64.4 ng/dL
Standard Deviation 32.2
|
93.3 ng/dL
Standard Deviation 51.9
|
120 ng/dL
Standard Deviation 60
|
SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
|---|---|---|---|
|
Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
|
6.0 hour
Interval 0.0 to 24.4
|
4.0 hour
Interval 0.0 to 24.9
|
6.0 hour
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43Population: ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=14 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=16 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=18 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
|---|---|---|---|
|
Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.
|
1063 ng*hour/dL
Standard Deviation 479
|
1458 ng*hour/dL
Standard Deviation 726
|
1974 ng*hour/dL
Standard Deviation 890
|
SECONDARY outcome
Timeframe: From Baseline to Day 43Population: Safety Analysis Set population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.
The data were presented using descriptive statistics for this outcome.
Outcome measures
| Measure |
Testosterone 1.25
n=20 Participants
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 Participants
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 Participants
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
|---|---|---|---|
|
Frequency of Adverse Events (AEs)
|
1 number of event
|
2 number of event
|
2 number of event
|
Adverse Events
Testosterone 1.25
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Testosterone 2.50
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Testosterone 3.75
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone 1.25
n=20 participants at risk
Subjects received testosterone gel 2% at dose of 1.25 mL (1 stroke - equivalent to 23 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 2.50
n=20 participants at risk
Subjects received testosterone gel 2% at dose of 2.50 mL (2 strokes - equivalent to 46 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
Testosterone 3.75
n=20 participants at risk
Subjects received testosterone gel 2% at dose of 3.75 mL (3 strokes - equivalent to 70 mg of testosterone) applied once daily for 10 consecutive days to the shoulder/upper arm.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
5.0%
1/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
0.00%
0/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
|
Investigations
Liver function test abnormal
|
5.0%
1/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
0.00%
0/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
0.00%
0/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
0.00%
0/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
10.0%
2/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
5.0%
1/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were presented.
|
0.00%
0/20 • Overall Treatment Period (43 days)
The treatment-emergent adverse event (TEAE), defined as any AE occurring after start of IMP administration and within the time of residual drug effect (5 days) (including PK assessment periods), or a pretreatment AE or preexisting medical condition that worsens in intensity after start of IMP, were 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