Trial Outcomes & Findings for A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males (NCT NCT02149264)
NCT ID: NCT02149264
Last Updated: 2017-10-26
Results Overview
The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
160 participants
Primary outcome timeframe
At Day 90
Results posted on
2017-10-26
Participant Flow
Subjects were recruited from 23 study sites in the United States.
Of the 940 screened subjects, 160 subjects were eligible to be enrolled into the study.
Participant milestones
| Measure |
Testosterone Gel (FE 999303)
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
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Overall Study
STARTED
|
159
|
|
Overall Study
COMPLETED
|
139
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Testosterone Gel (FE 999303)
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
Baseline characteristics by cohort
| Measure |
Testosterone Gel (FE 999303)
n=159 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
138 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
159 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Height
|
69.8 inches
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Weight
|
213.2 lbs
STANDARD_DEVIATION 28.2 • n=5 Participants
|
|
BMI
|
30.7 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Total International Index of Erectile Function Score - All Domains
|
36.3 units on a scale
STANDARD_DEVIATION 18.7 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Severity domain
|
12.0 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Distress domain
|
5.1 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Degree of interference domain
|
47.7 units on a scale
STANDARD_DEVIATION 22.9 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Timing domain
|
13.0 units on a scale
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Multidimensional Assessment of Fatigue
Global Fatigue Index (GFI)
|
27.5 units on a scale
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Short Form -12 (SF-12) Health survey
Physical Component Summary
|
48.4 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Short Form -12 (SF-12) Health survey
Mental Component Summary
|
43.7 units on a scale
STANDARD_DEVIATION 11.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 90Population: Full Analysis Set (FAS) population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.
The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=155 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
|
76.1 percentage of subjects
Interval 69.4 to 82.8
|
SECONDARY outcome
Timeframe: At 14, 35 and 56Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.
The data were presented using descriptive statistics. No statistical analysis was performed.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=155 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
Day 14
|
29.1 percentage of subjects
|
|
The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
Day 35
|
58.2 percentage of subjects
|
|
The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL
Day 56
|
71.2 percentage of subjects
|
SECONDARY outcome
Timeframe: At Days 35 and 90Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.
Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were: 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=155 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Change From Baseline in International Index of Erectile Function (IIEF) Score
Day 35
|
8.4 units on a scale
Standard Deviation 13.2
|
|
Change From Baseline in International Index of Erectile Function (IIEF) Score
Day 90
|
14.4 units on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: At Days 35 and 90Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.
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 (categorical in nature) are scored from 1-4. The scores are 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. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue).
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=155 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Severity domain score at Day 35
|
-3.6 units on a scale
Standard Deviation 4.8
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Distress domain score at Day 35
|
-1.7 units on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Degree of interference domain score at Day 35
|
-13.6 units on a scale
Standard Deviation 24.1
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Timing domain score at Day 35
|
-2.6 units on a scale
Standard Deviation 3.3
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
GFI score at Day 35
|
-8.3 units on a scale
Standard Deviation 10.1
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Severity domain score at Day 90
|
-5.2 units on a scale
Standard Deviation 4.9
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Distress domain score at Day 90
|
-2.2 units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Degree of interference domain score at Day 90
|
-16.7 units on a scale
Standard Deviation 24.5
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
Timing domain score at Day 90
|
-3.0 units on a scale
Standard Deviation 3.4
|
|
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score
GFI score at Day 90
|
-12.0 units on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: At Days 35 and 90Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.
Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains: PCS: 1. Physical Functioning (2 items, questions 2-3) 2. Role-Physical (2 items, questions 4-5) 3. Bodily Pain (1 item, question 8) 4. General Health (1 item, question 1) MCS: 1. Vitality (1 item, question 10) 2. Social Functioning (1 item, question 12) 3. Role-Emotional (2 items, questions 6-7) 4. Mental Health (2 items, questions 9 and 11) PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=155 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
PCS Day 35
|
1.2 units on a scale
Standard Deviation 7.0
|
|
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
PCS Day 90
|
1.8 units on a scale
Standard Deviation 7.1
|
|
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
MCS Day 35
|
6.3 units on a scale
Standard Deviation 9.5
|
|
Change From Baseline in Short Form-12 Health Survey (SF-12) Score
MCS Day 90
|
6.5 units on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point.
A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=155 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 69 mg dose
|
77.7 ng/dL
Standard Deviation 39.7
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 14 at 23 mg dose
|
268 ng/dL
Standard Deviation 80
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 23 mg dose
|
359 ng/dL
Standard Deviation 116
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 46 mg dose
|
361 ng/dL
Standard Deviation 152
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 23 mg dose
|
278 ng/dL
Standard Deviation 73
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 46 mg dose
|
429 ng/dL
Standard Deviation 127
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 69 mg dose
|
464 ng/dL
Standard Deviation 271
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 23 mg dose
|
368 ng/dL
Standard Deviation 121
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 46 mg dose
|
506 ng/dL
Standard Deviation 207
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 69 mg dose
|
438 ng/dL
Standard Deviation 164
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 14 at 23 mg dose
|
40.9 ng/dL
Standard Deviation 18.8
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 23 mg dose
|
56.3 ng/dL
Standard Deviation 18.0
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 46 mg dose
|
63.1 ng/dL
Standard Deviation 29.9
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 23 mg dose
|
44.2 ng/dL
Standard Deviation 11.1
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 46 mg dose
|
78.7 ng/dL
Standard Deviation 32.8
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 69 mg dose
|
75.2 ng/dL
Standard Deviation 43.3
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 23 mg dose
|
65.9 ng/dL
Standard Deviation 24.1
|
|
Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 46 mg dose
|
91.2 ng/dL
Standard Deviation 38.9
|
SECONDARY outcome
Timeframe: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point.
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=155 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 14 at 23 mg dose
|
6431 ng*hr/dL
Standard Deviation 1938
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 23 mg dose
|
8552 ng*hr/dL
Standard Deviation 2800
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 46 mg dose
|
8665 ng*hr/dL
Standard Deviation 3664
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 23 mg dose
|
6624 ng*hr/dL
Standard Deviation 1765
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 46 mg dose
|
10320 ng*hr/dL
Standard Deviation 3042
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 69 mg dose
|
11152 ng*hr/dL
Standard Deviation 6507
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 23 mg dose
|
8831 ng*hr/dL
Standard Deviation 2829
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 46 mg dose
|
12245 ng*hr/dL
Standard Deviation 5010
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 69 mg dose
|
10590 ng*hr/dL
Standard Deviation 3979
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 14 at 23 mg dose
|
980 ng*hr/dL
Standard Deviation 452
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 23 mg dose
|
1343 ng*hr/dL
Standard Deviation 435
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 46 mg dose
|
1515 ng*hr/dL
Standard Deviation 719
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 23 mg dose
|
1057 ng*hr/dL
Standard Deviation 270
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 46 mg dose
|
1893 ng*hr/dL
Standard Deviation 797
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 69 mg dose
|
1811 ng*hr/dL
Standard Deviation 1046
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 23 mg dose
|
1579 ng*hr/dL
Standard Deviation 560
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 46 mg dose
|
2210 ng*hr/dL
Standard Deviation 956
|
|
Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 69 mg dose
|
1876 ng*hr/dL
Standard Deviation 956
|
SECONDARY outcome
Timeframe: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to adverse event after Day 14 visit and not included in the analysis.
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=154 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 46 mg dose
|
2.08 hr
Interval 0.0 to 24.5
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 69 mg dose
|
3.87 hr
Interval 0.0 to 24.8
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 23 mg dose
|
4.12 hr
Interval 0.0 to 23.5
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 14 at 23 mg dose
|
2.04 hr
Interval 0.0 to 24.9
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 23 mg dose
|
2.15 hr
Interval 0.0 to 23.8
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 46 mg dose
|
2.00 hr
Interval 0.0 to 24.9
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 23 mg dose
|
2.00 hr
Interval 1.75 to 4.05
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 46 mg dose
|
2.08 hr
Interval 0.0 to 24.3
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 69 mg dose
|
2.00 hr
Interval 0.0 to 24.1
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 23 mg dose
|
4.02 hr
Interval 2.0 to 6.0
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 46 mg dose
|
2.02 hr
Interval 1.75 to 25.4
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 69 mg dose
|
2.08 hr
Interval 0.0 to 24.8
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 14 at 23 mg dose
|
3.97 hr
Interval 0.0 to 24.6
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 23 mg dose
|
3.04 hr
Interval 0.0 to 7.97
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 46 mg dose
|
2.94 hr
Interval 0.0 to 25.1
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 23 mg dose
|
2.00 hr
Interval 1.75 to 4.17
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 46 mg dose
|
3.75 hr
Interval 0.0 to 25.4
|
|
Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 69 mg dose
|
3.95 hr
Interval 0.0 to 24.9
|
SECONDARY outcome
Timeframe: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis.
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=154 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 46 mg dose
|
91.5 ng/dL
Standard Deviation 43.3
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 23 mg dose
|
68.6 ng/dL
Standard Deviation 19.0
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 46 mg dose
|
113 ng/dL
Standard Deviation 62
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 14 at 23 mg dose
|
435 ng/dL
Standard Deviation 195
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 23 mg dose
|
642 ng/dL
Standard Deviation 238
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 46 mg dose
|
732 ng/dL
Standard Deviation 387
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 23 mg dose
|
637 ng/dL
Standard Deviation 300
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 46 mg dose
|
890 ng/dL
Standard Deviation 424
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 69 mg dose
|
987 ng/dL
Standard Deviation 652
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 23 mg dose
|
721 ng/dL
Standard Deviation 254
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 46 mg dose
|
1228 ng/dL
Standard Deviation 640
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 69 mg dose
|
1099 ng/dL
Standard Deviation 595
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 14 at 23 mg dose
|
56.5 ng/dL
Standard Deviation 26.9
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 23 mg dose
|
79.2 ng/dL
Standard Deviation 26.0
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 69 mg dose
|
106 ng/dL
Standard Deviation 57
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 23 mg dose
|
91.4 ng/dL
Standard Deviation 34.8
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 46 mg dose
|
138 ng/dL
Standard Deviation 66
|
|
Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 69 mg dose
|
118 ng/dL
Standard Deviation 55
|
SECONDARY outcome
Timeframe: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90Population: FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis.
A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.
Outcome measures
| Measure |
Testosterone Gel (FE 999303)
n=154 Participants
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 46 mg dose
|
277 ng/dL
Standard Deviation 140
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 14 at 23 mg dose
|
194 ng/dL
Standard Deviation 64
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 23 mg dose
|
203 ng/dL
Standard Deviation 74
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 35 at 46 mg dose
|
216 ng/dL
Standard Deviation 93
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 23 mg dose
|
175 ng/dL
Standard Deviation 49
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 46 mg dose
|
262 ng/dL
Standard Deviation 115
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 56 at 69 mg dose
|
261 ng/dL
Standard Deviation 200
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 23 mg dose
|
191 ng/dL
Standard Deviation 49
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Total testosterone on Day 90 at 69 mg dose
|
229 ng/dL
Standard Deviation 82
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 14 at 23 mg dose
|
30.7 ng/dL
Standard Deviation 15.6
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 23 mg dose
|
41.0 ng/dL
Standard Deviation 12.7
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 35 at 46 mg dose
|
43.9 ng/dL
Standard Deviation 24.7
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 23 mg dose
|
33.2 ng/dL
Standard Deviation 9.6
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 46 mg dose
|
58.0 ng/dL
Standard Deviation 26.7
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 56 at 69 mg dose
|
52.9 ng/dL
Standard Deviation 32.3
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 23 mg dose
|
45.1 ng/dL
Standard Deviation 21.0
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 46 mg dose
|
62.5 ng/dL
Standard Deviation 26.4
|
|
Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone
Dihydrotestosterone on Day 90 at 69 mg dose
|
53.1 ng/dL
Standard Deviation 29.7
|
Adverse Events
Testosterone Gel (FE 999303)
Serious events: 5 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Testosterone Gel (FE 999303)
n=159 participants at risk
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.63%
1/159 • Number of events 1 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.63%
1/159 • Number of events 1 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Cardiac disorders
Angina unstable
|
0.63%
1/159 • Number of events 1 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Cardiac disorders
Myocardial infarction
|
0.63%
1/159 • Number of events 1 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
1/159 • Number of events 1 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
Other adverse events
| Measure |
Testosterone Gel (FE 999303)
n=159 participants at risk
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (up to three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
|
|---|---|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Gastrointestinal disorders
Toothache
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Application site dermatitis
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Application site erythema
|
2.5%
4/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Application site pruritus
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Application site rash
|
1.9%
3/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Cyst
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Fatigue
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Influenza like illness
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Oedema peripheral
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Pain
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Pyrexia
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
General disorders
Sluggishness
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Bronchitis
|
3.1%
5/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Cellulitis
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Gangrene
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Hordeolum
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
4/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Perineal abscess
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Sinusitis
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Tinea infection
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
5/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Infections and infestations
Viral infection
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Injury, poisoning and procedural complications
Wound
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Alanine aminotransferase increased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Blood cholesterol increased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Blood creatinine increased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Blood glucose increased
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Blood pressure increased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Blood triglycerides increased
|
1.9%
3/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Gamma-glutamyl transferase increased
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Haematocrit decreased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Haemoglobin decreased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Prostatic specific antigen increased
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Investigations
Weight increased
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Nervous system disorders
Hyposmia
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Psychiatric disorders
Anxiety
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Psychiatric disorders
Insomnia
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Renal and urinary disorders
Dysuria
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Epididymitis
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Reproductive system and breast disorders
Testicular atrophy
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
5/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Vascular disorders
Hot flush
|
0.63%
1/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
|
Vascular disorders
Hypertension
|
1.3%
2/159 • Overall study period (From Day 1 to Day 120 [last visit])
Adverse event occurring after start of study drug administration and within the time of residual drug effect (5 days), or a pre-treatment adverse event or pre-existing medical condition that worsened in intensity after treatment with the study drug and within the time of residual drug effect, are presented for the safety analysis set.
|
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