Trial Outcomes & Findings for A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel (NCT NCT01665599)
NCT ID: NCT01665599
Last Updated: 2017-10-26
Results Overview
The data were presented using descriptive statistics. No statistical analysis was performed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
180 participants
Primary outcome timeframe
Day 90
Results posted on
2017-10-26
Participant Flow
Subjects were recruited from 19 study centers (17 in the US and 2 in Canada).
Of the 656 screened subjects, 180 subjects were enrolled into the study.
Participant milestones
| Measure |
Testosterone Gel (FE 999303)
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Overall Study
STARTED
|
180
|
|
Overall Study
COMPLETED
|
172
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Testosterone Gel (FE 999303)
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Consent Withdrawn
|
1
|
|
Overall Study
Investigator/Sponsor decision
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Participant Left for More Than 3 Months
|
1
|
|
Overall Study
Could Not Continue Due to Time Constrain
|
1
|
Baseline Characteristics
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
Baseline characteristics by cohort
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
145 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
157 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Height, Continuous
|
70.3 Inches
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Weight, Continuous
|
211.3 pounds
STANDARD_DEVIATION 30.1 • n=5 Participants
|
|
BMI, Continuous
|
30 kg/m^2
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Total International Index of Erectile Function (IIEF) Score
|
31.9 units on a scale
STANDARD_DEVIATION 18.4 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Severity domain
|
11.9 units on a scale
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Distress domain
|
4.9 units on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Degree of interference domain
|
48.9 units on a scale
STANDARD_DEVIATION 24.3 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Timing domain
|
12.8 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Global Fatigue Index (GFI)
|
27.2 units on a scale
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Short Form -12 (SF-12) Health survey
Physical Component Summary
|
47.5 units on a scale
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Short Form -12 (SF-12) Health survey
Mental Component Summary
|
43.0 units on a scale
STANDARD_DEVIATION 10.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: Full Analysis set (FAS) population was used which comprised of subjects who had any available pharmacokinetic (PK) data for testosterone on Day 90.
The data were presented using descriptive statistics. No statistical analysis was performed.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=172 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
23 mg
|
2.9 percentage of participants
|
|
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
46 mg
|
4.7 percentage of participants
|
|
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
69 mg
|
77.9 percentage of participants
|
|
The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Overall
|
85.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1Population: FAS population was used which comprised of subjects who had any available PK data for testosterone on Day 90.
The data were presented using descriptive statistics. No statistical analysis was performed.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=172 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
|
51.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Day 1; 46 mg (n=180)
|
7,616 ng*hr/dL
Standard Deviation 2,242
|
|
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Day 90; 23 mg (n=5)
|
12,433 ng*hr/dL
Standard Deviation 3,100
|
|
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Day 90; 46 mg (n=12)
|
9,835 ng*hr/dL
Standard Deviation 3,831
|
|
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Day 90; 69 mg (n=155)
|
11,967 ng*hr/dL
Standard Deviation 4,439
|
|
Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)
Day 90; all doses (n=172)
|
11,825 ng*hr/dL
Standard Deviation 4,382
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Day 1; 46 mg (n=180)
|
4 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Day 90; 23 mg (n=5)
|
4 hour
Interval 1.75 to 18.0
|
|
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Day 90; 46 mg (n=12)
|
2.01 hour
Interval 0.0 to 8.0
|
|
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Day 90; 69 mg (n=155)
|
2.03 hour
Interval 0.0 to 17.5
|
|
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)
Day 90; all doses (n=172)
|
2.03 hour
Interval 0.0 to 18.0
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Day 1; 46 mg (n=180)
|
490 ng/dL
Standard Deviation 234
|
|
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Day 90; 23 mg (n=5)
|
944 ng/dL
Standard Deviation 253
|
|
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Day 90; 46 mg (n=12)
|
916 ng/dL
Standard Deviation 514
|
|
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Day 90; 69 mg (n=155)
|
1,432 ng/dL
Standard Deviation 1,050
|
|
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)
Day 90; all doses (n=172)
|
1,382 ng/dL
Standard Deviation 1,017
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Day 1; 46 mg (n=180)
|
316 ng/dL
Standard Deviation 92
|
|
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Day 90; 23 mg (n=5)
|
515 ng/dL
Standard Deviation 132
|
|
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Day 90; 46 mg (n=12)
|
407 ng/dL
Standard Deviation 160
|
|
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Day 90; 69 mg (n=155)
|
495 ng/dL
Standard Deviation 184
|
|
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)
Day 90; all doses (n=172)
|
489 ng/dL
Standard Deviation 182
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Day 1; 46 mg (n=180)
|
201 ng/dL
Standard Deviation 65
|
|
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Day 90; 23 mg (n=5)
|
317 ng/dL
Standard Deviation 112
|
|
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Day 90; 46 mg (n=12)
|
219 ng/dL
Standard Deviation 76
|
|
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Day 90; 69 mg (n=155)
|
222 ng/dL
Standard Deviation 89
|
|
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)
Day 90; all doses (n=172)
|
225 ng/dL
Standard Deviation 90
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of total testosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Day 1; 46 mg (n=180)
|
0 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Day 90; 23 mg (n=5)
|
8.00 hour
Interval 0.0 to 18.0
|
|
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Day 90; 46 mg (n=12)
|
12.1 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Day 90; 69 mg (n=155)
|
12.0 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)
Day 90; all doses (n=172)
|
12.0 hour
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of DHT.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Day 1; 46 mg (n=180)
|
982 ng*hr/dL
Standard Deviation 588
|
|
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Day 90; 23 mg (n=5)
|
1,537 ng*hr/dL
Standard Deviation 263
|
|
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Day 90; 46 mg (n=12)
|
1,329 ng*hr/dL
Standard Deviation 593
|
|
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Day 90; 69 mg (n=155)
|
1,604 ng*hr/dL
Standard Deviation 698
|
|
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ
Day 90; all doses (n=172)
|
1,582 ng*hr/dL
Standard Deviation 683
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of DHT.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of DHT Measuring Tmax
Day 90; 69 mg (n=155)
|
3.98 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of DHT Measuring Tmax
Day 90; all doses (n=172)
|
3.97 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of DHT Measuring Tmax
Day 1; 46 mg (n=180)
|
6 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of DHT Measuring Tmax
Day 90; 23 mg (n=5)
|
4.08 hour
Interval 2.0 to 18.0
|
|
Pharmacokinetics of DHT Measuring Tmax
Day 90; 46 mg (n=12)
|
2.11 hour
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of DHT.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of DHT Measuring Cmax
Day 1; 46 mg (n=180)
|
58.7 ng/dL
Standard Deviation 40.1
|
|
Pharmacokinetics of DHT Measuring Cmax
Day 90; 23 mg (n=5)
|
92.1 ng/dL
Standard Deviation 21.9
|
|
Pharmacokinetics of DHT Measuring Cmax
Day 90; 46 mg (n=12)
|
82.5 ng/dL
Standard Deviation 37.7
|
|
Pharmacokinetics of DHT Measuring Cmax
Day 90; 69 mg (n=155)
|
108 ng/dL
Standard Deviation 51.0
|
|
Pharmacokinetics of DHT Measuring Cmax
Day 90; all doses (n=172)
|
106 ng/dL
Standard Deviation 50
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of DHT.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of DHT Measuring Cave
Day 1; 46 mg (n=180)
|
40.8 ng/dL
Standard Deviation 24.5
|
|
Pharmacokinetics of DHT Measuring Cave
Day 90; 23 mg (n=5)
|
63.7 ng/dL
Standard Deviation 11.3
|
|
Pharmacokinetics of DHT Measuring Cave
Day 90; 46 mg (n=12)
|
55.1 ng/dL
Standard Deviation 24.7
|
|
Pharmacokinetics of DHT Measuring Cave
Day 90; 69 mg (n=155)
|
66.3 ng/dL
Standard Deviation 29.0
|
|
Pharmacokinetics of DHT Measuring Cave
Day 90; all doses (n=172)
|
65.4 ng/dL
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of DHT.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of DHT Measuring Cmin
Day 1; 46 mg (n=180)
|
18.0 ng/dL
Standard Deviation 9.9
|
|
Pharmacokinetics of DHT Measuring Cmin
Day 90; 23 mg (n=5)
|
45.4 ng/dL
Standard Deviation 10.8
|
|
Pharmacokinetics of DHT Measuring Cmin
Day 90; 46 mg (n=12)
|
35.7 ng/dL
Standard Deviation 14.0
|
|
Pharmacokinetics of DHT Measuring Cmin
Day 90; 69 mg (n=155)
|
42.8 ng/dL
Standard Deviation 22.0
|
|
Pharmacokinetics of DHT Measuring Cmin
Day 90; all doses (n=172)
|
42.4 ng/dL
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: Day 1; Day 90Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
A validated LC/MS/MS method was used to determine the levels of DHT.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Pharmacokinetics of DHT Measuring Tmin
Day 1; 46 mg (n=180)
|
0 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of DHT Measuring Tmin
Day 90; 23 mg (n=5)
|
8.00 hour
Interval 0.0 to 18.0
|
|
Pharmacokinetics of DHT Measuring Tmin
Day 90; 46 mg (n=12)
|
16.0 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of DHT Measuring Tmin
Day 90; 69 mg (n=155)
|
12.0 hour
Interval 0.0 to 24.0
|
|
Pharmacokinetics of DHT Measuring Tmin
Day 90; all doses (n=172)
|
12.0 hour
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 91Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are: 1. Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30) 2. Orgasmic function (2 items, questions 9-10) (Score range: 0-10) 3. Sexual desire (2 items, questions 11-12) (Score range: 2-10) 4. Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15) 5. Overall satisfaction (2 items, questions 13-14) (Score range: 2-10) A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire
|
13.8 units on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: Day 91Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
The MAF contains four sub-domains: 1. Severity (2 items, questions 1-2) (Score range: 2-20) 2. Distress (1 item, question 3) (Score range: 1-10) 3. Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110) 4. Timing (2 items, questions 15-16) (Score range: 5-20) A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue. To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue). The data were presented using descriptive statistics.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
Severity domain score
|
-5.3 units on a scale
Standard Deviation 5.3
|
|
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
Distress domain score
|
-2.0 units on a scale
Standard Deviation 2.7
|
|
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
Degree of interference domain score
|
-18.9 units on a scale
Standard Deviation 22.0
|
|
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
Timing domain score
|
-2.8 units on a scale
Standard Deviation 3.5
|
|
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire
GFI score
|
-11.4 units on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Day 91Population: ITT population was used which comprised of all participants who received at least one dose of IMP.
Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains: PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item) MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item) The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and standard deviation of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The data were presented using descriptive statistics.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=180 Participants
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Change From Baseline in the SF-12 Health Questionnaire
Physical Component Summary (PCS)
|
3.7 units on a scale
Standard Deviation 7.1
|
|
Change From Baseline in the SF-12 Health Questionnaire
Mental Component Summary (MCS)
|
7.9 units on a scale
Standard Deviation 10.4
|
Adverse Events
Testosterone Gel (FE 999303)
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone Gel (FE 999303)
n=180 participants at risk
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.56%
1/180 • Number of events 1 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.56%
1/180 • Number of events 1 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Injury, poisoning and procedural complications
Compression fracture lumbar spine
|
0.56%
1/180 • Number of events 1 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
Other adverse events
| Measure |
Testosterone Gel (FE 999303)
n=180 participants at risk
Subjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations \[69 mg\] or single actuation \[23 mg\], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Gastrointestinal disorders
Constipation
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Gastrointestinal disorders
Toothache
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
General disorders
Chest pain
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
General disorders
Inflammation
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
General disorders
Pyrexia
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Bronchitis
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Diverticulitis
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Folliculitis
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Gastroenteritis viral
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
2/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Periumbilical abscess
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Pneumonia
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Respiratory tract infection
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Sinusitis
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Tooth abscess
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
6/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Infections and infestations
Urinary tract infection
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Investigations
Blood pressure increased
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Investigations
Blood triglycerides increased
|
2.2%
4/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.1%
2/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Investigations
Haematocrit increased
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Investigations
Haemoglobin increased
|
1.1%
2/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Investigations
Heart rate irregular
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Investigations
Prostatic specific antigen increased
|
1.7%
3/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Nervous system disorders
Dizziness
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Nervous system disorders
Headache
|
1.1%
2/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Nervous system disorders
Sciatica
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Psychiatric disorders
Depression
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Psychiatric disorders
Insomnia
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Renal and urinary disorders
Calculus bladder
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Renal and urinary disorders
Renal cyst
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Reproductive system and breast disorders
Ejaculation failure
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Reproductive system and breast disorders
Scrotal cyst
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
2/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
3/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.1%
2/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Surgical and medical procedures
Cataract operation
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Surgical and medical procedures
Dental operation
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Vascular disorders
Hypertension
|
1.7%
3/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
|
Vascular disorders
Phlebitis
|
0.56%
1/180 • Overall study period (From Day -45 [screening] to Day 91 [last visit])
The treatment-emergent adverse event, defined as any adverse event occurring after start of IMP administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and within the time of residual drug effect, were presented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER