Trial Outcomes & Findings for Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (NCT NCT03198728)
NCT ID: NCT03198728
Last Updated: 2023-06-28
Results Overview
Efficacy assessment includes T Cavg calculated from NaF/EDTA plasma testosterone. The T Cavg is calculated as the 24-hour area under the curve (AUC), divided by 24, at Day 90, based on a fifteen blood samples (PK samples) taken over the 24-hours. The T concentration in each sample is measured using a validated LC-MS/MS method. The use of NaF/EDTA plasma tubes chilled after sample collection provides the most accurate values, as the prodrug TU may degrade post-sample collection, artificially inflating testosterone values.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
314 participants
Primary outcome timeframe
90 days
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
SOV2012-F1-Treated
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-Gel™ Treated
100 patients treated with AndroGel, according to label, using samples on Days 14 and 42 with dose adjustment on Days 28 and 56.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
100
|
|
Overall Study
COMPLETED
|
162
|
76
|
|
Overall Study
NOT COMPLETED
|
52
|
24
|
Reasons for withdrawal
| Measure |
SOV2012-F1-Treated
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-Gel™ Treated
100 patients treated with AndroGel, according to label, using samples on Days 14 and 42 with dose adjustment on Days 28 and 56.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
5
|
|
Overall Study
Lost to Follow-up
|
21
|
7
|
|
Overall Study
Physician Decision
|
7
|
2
|
|
Overall Study
Withdrawal by Subject
|
14
|
10
|
Baseline Characteristics
Data not collected for participants in the Androgel Treated Arm
Baseline characteristics by cohort
| Measure |
SOV2012-F1-Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-Gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 56.
AndroGel: topical testosterone gel, 1.62%
|
Total
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 9.15 • n=214 Participants
|
50.7 years
STANDARD_DEVIATION 9.30 • n=100 Participants
|
49.7 years
STANDARD_DEVIATION 9.21 • n=314 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=214 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=314 Participants
|
|
Sex: Female, Male
Male
|
214 Participants
n=214 Participants
|
100 Participants
n=100 Participants
|
314 Participants
n=314 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=214 Participants
|
27 Participants
n=100 Participants
|
82 Participants
n=314 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=214 Participants
|
73 Participants
n=100 Participants
|
232 Participants
n=314 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=214 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=314 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=214 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=314 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=214 Participants
|
2 Participants
n=100 Participants
|
3 Participants
n=314 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=214 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=314 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=214 Participants
|
11 Participants
n=100 Participants
|
45 Participants
n=314 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=214 Participants
|
86 Participants
n=100 Participants
|
257 Participants
n=314 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=214 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=314 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=214 Participants
|
1 Participants
n=100 Participants
|
8 Participants
n=314 Participants
|
|
Weight at Baseline
|
108.48 kg
STANDARD_DEVIATION 22.827 • n=214 Participants
|
108.97 kg
STANDARD_DEVIATION 24.544 • n=100 Participants
|
108.63 kg
STANDARD_DEVIATION 23.349 • n=314 Participants
|
|
Body Mass Index (BMI)
|
34.12 kg/m^2
STANDARD_DEVIATION 7.056 • n=214 Participants
|
34.33 kg/m^2
STANDARD_DEVIATION 6.486 • n=100 Participants
|
34.19 kg/m^2
STANDARD_DEVIATION 6.870 • n=314 Participants
|
|
Assigned breakfast diet
Low-fat Breakfast
|
27 Participants
n=214 Participants • Data not collected for participants in the Androgel Treated Arm
|
—
|
27 Participants
n=214 Participants • Data not collected for participants in the Androgel Treated Arm
|
|
Assigned breakfast diet
Normal-fat Breakfast
|
54 Participants
n=214 Participants • Data not collected for participants in the Androgel Treated Arm
|
—
|
54 Participants
n=214 Participants • Data not collected for participants in the Androgel Treated Arm
|
|
Assigned breakfast diet
High-fat Breakfast
|
130 Participants
n=214 Participants • Data not collected for participants in the Androgel Treated Arm
|
—
|
130 Participants
n=214 Participants • Data not collected for participants in the Androgel Treated Arm
|
|
Assigned breakfast diet
Missing
|
3 Participants
n=214 Participants • Data not collected for participants in the Androgel Treated Arm
|
—
|
3 Participants
n=214 Participants • Data not collected for participants in the Androgel Treated Arm
|
|
Diabetic Status
With Diabetes Mellitus
|
31 Participants
n=214 Participants
|
13 Participants
n=100 Participants
|
44 Participants
n=314 Participants
|
|
Diabetic Status
Without Diabetes Mellitus
|
183 Participants
n=214 Participants
|
87 Participants
n=100 Participants
|
270 Participants
n=314 Participants
|
|
Hypertensive Status
Hypertensive
|
127 Participants
n=214 Participants
|
60 Participants
n=100 Participants
|
187 Participants
n=314 Participants
|
|
Hypertensive Status
Not Hypertensive
|
87 Participants
n=214 Participants
|
40 Participants
n=100 Participants
|
127 Participants
n=314 Participants
|
|
Hypertensive Treatment Status
With Antihypertensive Therapy at Visit 3 (Day 1)
|
67 Participants
n=214 Participants
|
43 Participants
n=100 Participants
|
110 Participants
n=314 Participants
|
|
Hypertensive Treatment Status
Without Antihypertensive Therapy at Visit 3 (Day 1)
|
147 Participants
n=214 Participants
|
57 Participants
n=100 Participants
|
204 Participants
n=314 Participants
|
|
Hypogonadal Status
Primary
|
8 Participants
n=214 Participants
|
3 Participants
n=100 Participants
|
11 Participants
n=314 Participants
|
|
Hypogonadal Status
Secondary
|
206 Participants
n=214 Participants
|
97 Participants
n=100 Participants
|
303 Participants
n=314 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Efficacy Set
Efficacy assessment includes T Cavg calculated from NaF/EDTA plasma testosterone. The T Cavg is calculated as the 24-hour area under the curve (AUC), divided by 24, at Day 90, based on a fifteen blood samples (PK samples) taken over the 24-hours. The T concentration in each sample is measured using a validated LC-MS/MS method. The use of NaF/EDTA plasma tubes chilled after sample collection provides the most accurate values, as the prodrug TU may degrade post-sample collection, artificially inflating testosterone values.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=185 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1.
|
166 Participants
|
—
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Full Analysis Set
To determine the percentage of treated subjects with maximum plasma testosterone concentration (T Cmax) values (a) \< 1.5X Upper Limit of Normal (ULN); (b) 1.8X to 2.5X ULN; and (c) \> 2.5X ULN. For NaF/EDTA plasma, thresholds are 1200, 1440 and 2000 ng/dL of T. For serum, thresholds are 1500, 1800 and 2500 ng/dL of T. Note that the endpoint concerns only the investigational treatment SOV2012-F1 and the AndroGel results are reported for completeness. The reported percentages do not sum to 100% as the FDA criteria do not specify the percentage of subjects in the window of ≥ 1.5X and ≤ 1.8X the ULN.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=186 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=90 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Percentages of Participants in Each Category for Maximum Plasma Concentration
T Cmax < 1200 ng/dL for SOV2012-F1; T Cmax < 1500 ng/dL for Andro-gel after 90 days
|
76.9 percentage of actual number of subjects
|
92.2 percentage of actual number of subjects
|
|
Percentages of Participants in Each Category for Maximum Plasma Concentration
T Cmax 1440 to 2000 ng/dL for SOV2012-F1; T Cmax 1800 to 2500 ng/dL for Andro-gel after 90 days
|
7.5 percentage of actual number of subjects
|
2.2 percentage of actual number of subjects
|
|
Percentages of Participants in Each Category for Maximum Plasma Concentration
T Cmax > 2000 ng/dL for SOV2012-F1; T Cmax > 2500 ng/dL for Andro-gel after 90days
|
3.2 percentage of actual number of subjects
|
1.1 percentage of actual number of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment) to 90 days and 365 daysPopulation: Full Analysis Set
Patient reported outcomes will be assessed by the International Prostate Symptom Score (I-PSS) Reporting a score on a scale 0 to 35 (asymptomatic to very symptomatic). Mean change from baseline is reported and is the difference between the score at Baseline (pre-treatment) and at Day 90 and Day 365. Thus, a positive value at Day 90 or Day 365 represents an increase in the score from baseline.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in the IPSS
Baseline
|
4.4 score on a scale
Standard Deviation 4.12
|
5.4 score on a scale
Standard Deviation 4.94
|
|
Change From Baseline in the IPSS
Change from baseline (Visit 8 - Day 90)
|
0.2 score on a scale
Standard Deviation 3.56
|
0.7 score on a scale
Standard Deviation 3.72
|
|
Change From Baseline in the IPSS
Change from baseline (Visit Day 365)
|
0.6 score on a scale
Standard Deviation 3.99
|
1.0 score on a scale
Standard Deviation 3.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment) to 90 days and 365 daysPopulation: Full Analysis Set
Patient reported outcomes are 7-day average score at baseline, and average change from baseline (CfB) at Day 90 and Day 365. Weekly daily average scores calculated for diaries completed at least 3 of 7 days. The three domains are: Sexual desire subscale 0=None, 1=very low to 7=Very High. Sexual enjoyment with/without partner subscale 0=None to 7=Very high enjoyment/pleasure. Partner availability not used in scoring. Positive CfB desirable. Positive and negative mood subscales 0=Not at all true to 7=Very true (Likert 7-point scale, 7-day average reported). Positive mood (sum of 4 questions) score range = 0 to 28; positive changes from baseline desirable. Negative mood (sum of 5 questions) score range = 0 to 35; negative CfB desirable. Weekly sexual activity subscale score is 7\*(# of activities per week / # of days reported). Percent full erection uses scale of 0-100% (10% steps). Satisfaction with erection 0=not satisfactory to 7=very satisfactory. Positive CfB desirable.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Overall Level of sexual desire Visit 3 - Day 1 (baseline)
|
1.990 score on a scale
Standard Deviation 1.4195
|
2.039 score on a scale
Standard Deviation 1.5659
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Overall Level of sexual desire Visit 8 - Day 90
|
1.674 score on a scale
Standard Deviation 1.6851
|
1.256 score on a scale
Standard Deviation 1.5583
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Overall Level of sexual desire Visit Day 365
|
1.552 score on a scale
Standard Deviation 1.7596
|
1.372 score on a scale
Standard Deviation 1.6968
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Without a Partner Visit 3 - Day 1 (baseline)
|
0.754 score on a scale
Standard Deviation 0.9640
|
0.875 score on a scale
Standard Deviation 1.1397
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Without a Partner Visit 8 - Day 90
|
0.742 score on a scale
Standard Deviation 1.6478
|
0.498 score on a scale
Standard Deviation 1.2075
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Without a Partner Visit Day 365
|
0.920 score on a scale
Standard Deviation 1.5566
|
0.769 score on a scale
Standard Deviation 1.5840
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
With a Partner Visit 3 - Day 1 (baseline)
|
0.954 score on a scale
Standard Deviation 1.2033
|
0.840 score on a scale
Standard Deviation 1.2928
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
With a Partner Visit 8 - Day 90
|
1.168 score on a scale
Standard Deviation 1.7335
|
0.594 score on a scale
Standard Deviation 1.7373
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
With a Partner Visit Day 365
|
1.106 score on a scale
Standard Deviation 1.6670
|
0.760 score on a scale
Standard Deviation 1.8284
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Negative Mood Visit 3 - Day 1 (baseline)
|
9.258 score on a scale
Standard Deviation 5.8557
|
9.847 score on a scale
Standard Deviation 5.0938
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Negative Mood Visit 8 - Day 90
|
-2.205 score on a scale
Standard Deviation 5.6199
|
-1.886 score on a scale
Standard Deviation 5.5670
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Negative Mood Visit Day 365
|
-3.011 score on a scale
Standard Deviation 5.3399
|
-1.435 score on a scale
Standard Deviation 5.7065
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Positive mood - Visit 3 - Day 1 (baseline)
|
16.799 score on a scale
Standard Deviation 5.1778
|
15.742 score on a scale
Standard Deviation 5.5015
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Positive mood - Visit 8 - Day 90
|
2.513 score on a scale
Standard Deviation 5.0149
|
3.347 score on a scale
Standard Deviation 5.2716
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Positive mood - Day 365
|
3.407 score on a scale
Standard Deviation 5.1065
|
2.817 score on a scale
Standard Deviation 5.1714
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Sexual Activity Score Visit 3 - Day 1 (baseline)
|
15.314 score on a scale
Standard Deviation 13.8521
|
12.581 score on a scale
Standard Deviation 12.0706
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Sexual Activity Score Visit 8 - Day 90
|
12.284 score on a scale
Standard Deviation 15.9338
|
10.951 score on a scale
Standard Deviation 17.4041
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Sexual Activity Score Day 365
|
12.009 score on a scale
Standard Deviation 16.5438
|
12.591 score on a scale
Standard Deviation 17.7272
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Erection Grade, Visit 3 - Day 1 (baseline)
|
32.145 score on a scale
Standard Deviation 22.9941
|
30.652 score on a scale
Standard Deviation 23.9078
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Erection Grade, Visit 8 - Day 90
|
17.494 score on a scale
Standard Deviation 25.0678
|
12.619 score on a scale
Standard Deviation 22.6952
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Erection Grade, Day 365
|
14.235 score on a scale
Standard Deviation 28.9806
|
17.584 score on a scale
Standard Deviation 23.1670
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Erection Duration, Visit 3 - Day 1 (baseline)
|
1.985 score on a scale
Standard Deviation 1.4894
|
1.814 score on a scale
Standard Deviation 1.5321
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Erection Duration, Visit 8 - Day 90
|
1.480 score on a scale
Standard Deviation 1.7137
|
1.012 score on a scale
Standard Deviation 1.7166
|
|
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Erection Duration, Day 365
|
1.300 score on a scale
Standard Deviation 1.8420
|
1.501 score on a scale
Standard Deviation 1.6751
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT)Population: Full Analysis Set
Patient reported outcomes assessed by the Short-Form Survey (SF-36). This scale assesses 8 health concepts: 1. limitations in physical activities because of health problems 2. limitations in social activities because of physical or emotional problems 3. limitations in usual role activities because of physical health problems 4. bodily pain 5. general mental health (psychological distress and well-being) 6. limitations in usual role activities because of emotional problems 7. vitality (energy and fatigue) 8. general health perceptions. Each domain is scored from 0-100 with a score of 0 = maximum disability and a score of 100 = no disability. End of Treatment (EOT) occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure towards less disability. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and EOT scores.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in the SF-36
Emotional Well-being (Baseline)
|
72.4 score on a scale
Standard Deviation 17.55
|
68.0 score on a scale
Standard Deviation 18.98
|
|
Change From Baseline in the SF-36
Emotional Well-being (End of Treatment)
|
7.1 score on a scale
Standard Deviation 15.44
|
5.6 score on a scale
Standard Deviation 15.37
|
|
Change From Baseline in the SF-36
Energy/Fatigue (Baseline)
|
61.0 score on a scale
Standard Deviation 20.22
|
53.0 score on a scale
Standard Deviation 21.91
|
|
Change From Baseline in the SF-36
Energy/Fatigue (End of Treatment)
|
16.6 score on a scale
Standard Deviation 21.00
|
15.5 score on a scale
Standard Deviation 21.12
|
|
Change From Baseline in the SF-36
General Health (Baseline)
|
69.0 score on a scale
Standard Deviation 17.09
|
67.0 score on a scale
Standard Deviation 18.33
|
|
Change From Baseline in the SF-36
General Health (End of Treatment)
|
3.5 score on a scale
Standard Deviation 16.87
|
6.9 score on a scale
Standard Deviation 15.46
|
|
Change From Baseline in the SF-36
Health Change (Baseline)
|
65.2 score on a scale
Standard Deviation 20.66
|
59.6 score on a scale
Standard Deviation 18.66
|
|
Change From Baseline in the SF-36
Health Change (End of Treatment)
|
14.6 score on a scale
Standard Deviation 26.81
|
7.0 score on a scale
Standard Deviation 24.16
|
|
Change From Baseline in the SF-36
Pain (Baseline)
|
77.17 score on a scale
Standard Deviation 21.103
|
70.57 score on a scale
Standard Deviation 22.619
|
|
Change From Baseline in the SF-36
Pain (End of Treatment)
|
4.16 score on a scale
Standard Deviation 21,778
|
1.43 score on a scale
Standard Deviation 21.834
|
|
Change From Baseline in the SF-36
Physical Functioning (Baseline)
|
85.5 score on a scale
Standard Deviation 19.03
|
83.3 score on a scale
Standard Deviation 19.05
|
|
Change From Baseline in the SF-36
Physical Functioning (End of Treatment)
|
3.6 score on a scale
Standard Deviation 17.57
|
6.8 score on a scale
Standard Deviation 19.82
|
|
Change From Baseline in the SF-36
Role Limitations due to Emotional Problems (Baseline)
|
85.317 score on a scale
Standard Deviation 30.2358
|
79.116 score on a scale
Standard Deviation 34.4177
|
|
Change From Baseline in the SF-36
Role Limitations due to Emotional Problems (End of Treatment)
|
12.081 score on a scale
Standard Deviation 39.3671
|
5.778 score on a scale
Standard Deviation 35.2483
|
|
Change From Baseline in the SF-36
Role Limitations due to Physical Health (Baseline)
|
82.1 score on a scale
Standard Deviation 31.09
|
75.0 score on a scale
Standard Deviation 35.14
|
|
Change From Baseline in the SF-36
Role Limitations due to Physical Health (End of Treatment)
|
12.4 score on a scale
Standard Deviation 41.06
|
14.3 score on a scale
Standard Deviation 39.67
|
|
Change From Baseline in the SF-36
Social Functioning (Baseline)
|
84.75 score on a scale
Standard Deviation 18.527
|
83.73 score on a scale
Standard Deviation 18.799
|
|
Change From Baseline in the SF-36
Social Functioning (End of Treatment)
|
9.31 score on a scale
Standard Deviation 22.140
|
6.83 score on a scale
Standard Deviation 22.161
|
|
Change From Baseline in the SF-36
Mental Health Composite (Baseline)
|
51.885 score on a scale
Standard Deviation 8.6492
|
49.025 score on a scale
Standard Deviation 10.5313
|
|
Change From Baseline in the SF-36
Mental Health Composite (End of Treatment)
|
5.478 score on a scale
Standard Deviation 9.8093
|
3.515 score on a scale
Standard Deviation 9.1373
|
|
Change From Baseline in the SF-36
Physical Health Composite (Baseline)
|
49.229 score on a scale
Standard Deviation 8.3286
|
48.002 score on a scale
Standard Deviation 8.7737
|
|
Change From Baseline in the SF-36
Physical Health Composite (End of Treatment)
|
1.558 score on a scale
Standard Deviation 7.5381
|
2.968 score on a scale
Standard Deviation 8.1428
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT)Population: Full Analysis Set
Patient reported outcomes are assessed by the International Index of Erectile Function (IIEF). A score of 0-5 (higher score indicating improvement) is awarded to each of the 15 questions that examine overall satisfaction (2 questions, total possible score=10), and the 4 main domains of male sexual function: erectile function (6 questions, total possible score=30), orgasmic function (2 questions, total possible score=10), sexual desire (2 questions, total possible score=10), and intercourse satisfaction (3 questions, total possible score=15). The IIEF results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment (EOT). EOT occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and End of Treatment scores.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in the IIEF
Erectile Function (Baseline)
|
19.8 score on a scale
Standard Deviation 8.99
|
17.1 score on a scale
Standard Deviation 9.62
|
|
Change From Baseline in the IIEF
Erectile Function (End of Treatment)
|
5.1 score on a scale
Standard Deviation 8.30
|
4.1 score on a scale
Standard Deviation 8.35
|
|
Change From Baseline in the IIEF
Intercourse Satisfaction (Baseline)
|
8.4 score on a scale
Standard Deviation 5.17
|
6.8 score on a scale
Standard Deviation 5.55
|
|
Change From Baseline in the IIEF
Intercourse Satisfaction (End of Treatment)
|
2.4 score on a scale
Standard Deviation 4.56
|
2.4 score on a scale
Standard Deviation 4.81
|
|
Change From Baseline in the IIEF
Orgasmic Function (Baseline)
|
7.3 score on a scale
Standard Deviation 3.45
|
6.7 score on a scale
Standard Deviation 3.42
|
|
Change From Baseline in the IIEF
Orgasmic Function (End of Treatment)
|
1.5 score on a scale
Standard Deviation 3.61
|
2.4 score on a scale
Standard Deviation 4.81
|
|
Change From Baseline in the IIEF
Sexual Desire (Baseline)
|
3.6 score on a scale
Standard Deviation 1.12
|
3.7 score on a scale
Standard Deviation 1.10
|
|
Change From Baseline in the IIEF
Sexual Desire (End of Treatment)
|
0.7 score on a scale
Standard Deviation 1.25
|
0.9 score on a scale
Standard Deviation 1.10
|
|
Change From Baseline in the IIEF
Overall Satisfaction (Baseline)
|
4.8 score on a scale
Standard Deviation 2.31
|
4.1 score on a scale
Standard Deviation 2.27
|
|
Change From Baseline in the IIEF
Overall Satisfaction Visit Day 365
|
2.3 score on a scale
Standard Deviation 2.55
|
1.6 score on a scale
Standard Deviation 2.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.Population: Safety Set
The measured value is the FSG concentration reported as mg/dL. The FSG results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in Fasting Serum Glucose (FSG) Concentration
Baseline
|
108.6 mg/dL
Standard Deviation 31.19
|
110.3 mg/dL
Standard Deviation 26.01
|
|
Change From Baseline in Fasting Serum Glucose (FSG) Concentration
Visit 8 - Day 90
|
4.2 mg/dL
Standard Deviation 24.84
|
3.0 mg/dL
Standard Deviation 23.51
|
|
Change From Baseline in Fasting Serum Glucose (FSG) Concentration
Visit 10 - Day 180
|
1.4 mg/dL
Standard Deviation 24.54
|
2.4 mg/dL
Standard Deviation 21.48
|
|
Change From Baseline in Fasting Serum Glucose (FSG) Concentration
Visit 12 - Day 270
|
1.4 mg/dL
Standard Deviation 21.82
|
6.2 mg/dL
Standard Deviation 31.97
|
|
Change From Baseline in Fasting Serum Glucose (FSG) Concentration
End of Treatment
|
-4.7 mg/dL
Standard Deviation 20.41
|
-0.8 mg/dL
Standard Deviation 21.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.Population: Safety Set
The measured value is the insulin concentration reported as in units of uU/mL. The insulin results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in Fasting Insulin Concentration
Baseline
|
27.30 uU/mL
Standard Deviation 38.030
|
24.83 uU/mL
Standard Deviation 18.555
|
|
Change From Baseline in Fasting Insulin Concentration
Visit 8 - Day 90
|
3.59 uU/mL
Standard Deviation 56.110
|
2.43 uU/mL
Standard Deviation 19.328
|
|
Change From Baseline in Fasting Insulin Concentration
Visit 10 - Day 180
|
2.77 uU/mL
Standard Deviation 54.045
|
5.12 uU/mL
Standard Deviation 46.035
|
|
Change From Baseline in Fasting Insulin Concentration
Visit 12 - Day 270
|
5.12 uU/mL
Standard Deviation 63.889
|
0.54 uU/mL
Standard Deviation 20.026
|
|
Change From Baseline in Fasting Insulin Concentration
End of Treatment
|
-5.24 uU/mL
Standard Deviation 43.047
|
-2.58 uU/mL
Standard Deviation 14.967
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.Population: Safety Set
Changes from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), as mmHg. The blood pressure results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the measured SBP or DBP.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Clinic systolic BP - Baseline
|
125.8 mmHg
Standard Deviation 9.122
|
125.95 mmHg
Standard Deviation 10.130
|
|
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Clinic systolic BP - 90 day
|
2.16 mmHg
Standard Deviation 10.400
|
3.07 mmHg
Standard Deviation 9.797
|
|
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Clinic systolic BP - 180 day
|
1.89 mmHg
Standard Deviation 10.174
|
1.91 mmHg
Standard Deviation 9.044
|
|
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Clinic systolic BP - 365 day
|
2.75 mmHg
Standard Deviation 9.501
|
3.38 mmHg
Standard Deviation 10.492
|
|
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Clinic diastolic BP - Baseline
|
78.88 mmHg
Standard Deviation 6.340
|
79.19 mmHg
Standard Deviation 6.624
|
|
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Clinic diastolic BP - 90 day
|
0.58 mmHg
Standard Deviation 6.800
|
1.10 mmHg
Standard Deviation 8.262
|
|
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Clinic diastolic BP - 180 day
|
0.67 mmHg
Standard Deviation 6.014
|
2.60 mmHg
Standard Deviation 6.826
|
|
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Clinic diastolic BP - 365 day
|
1.14 mmHg
Standard Deviation 6.119
|
1.75 mmHg
Standard Deviation 7.213
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.Population: Safety set
Liver function tests (ALT, AST, total bilirubin, alkaline phosphatase). The liver function test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the liver function test value
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in Liver Function Tests
Alkaline Phosphatase (Baseline)
|
72.8 U/L
Standard Deviation 18.79
|
74.0 U/L
Standard Deviation 20.19
|
|
Change From Baseline in Liver Function Tests
Alkaline Phosphatase (Visit 8 - Day 90)
|
-6.0 U/L
Standard Deviation 11.03
|
-1.2 U/L
Standard Deviation 8.90
|
|
Change From Baseline in Liver Function Tests
Alkaline Phosphatase (Visit 10 - Day 180)
|
-4.2 U/L
Standard Deviation 12.14
|
-1.6 U/L
Standard Deviation 10.13
|
|
Change From Baseline in Liver Function Tests
Alkaline Phosphatase (Visit 12 - Day 270)
|
-5.5 U/L
Standard Deviation 10.57
|
-2.1 U/L
Standard Deviation 9.96
|
|
Change From Baseline in Liver Function Tests
Alkaline Phosphatase (Visit Day 365)
|
-4.5 U/L
Standard Deviation 11.42
|
-1.5 U/L
Standard Deviation 10.38
|
|
Change From Baseline in Liver Function Tests
Alkaline Phosphatase (End of Treatment)
|
-4.0 U/L
Standard Deviation 11.31
|
-1.5 U/L
Standard Deviation 10.37
|
|
Change From Baseline in Liver Function Tests
Alanine Aminotransferase (ALT) - Baseline
|
30.5 U/L
Standard Deviation 13.59
|
31.0 U/L
Standard Deviation 12.64
|
|
Change From Baseline in Liver Function Tests
Alanine Aminotransferase (ALT), Visit 8 - Day 90
|
-2.6 U/L
Standard Deviation 14.28
|
-0.0 U/L
Standard Deviation 13.30
|
|
Change From Baseline in Liver Function Tests
Alanine Aminotransferase (ALT), Visit 10 - Day 180
|
-2.9 U/L
Standard Deviation 11.44
|
0.9 U/L
Standard Deviation 16.64
|
|
Change From Baseline in Liver Function Tests
Alanine Aminotransferase (ALT), Visit 12 - Day 270
|
-2.2 U/L
Standard Deviation 12.76
|
0.7 U/L
Standard Deviation 17.25
|
|
Change From Baseline in Liver Function Tests
Alanine Aminotransferase (ALT), Visit Day 365
|
-1.4 U/L
Standard Deviation 12.89
|
1.3 U/L
Standard Deviation 14.55
|
|
Change From Baseline in Liver Function Tests
Alanine Aminotransferase (ALT) - End of Treatment
|
-0.4 U/L
Standard Deviation 19.84
|
0.9 U/L
Standard Deviation 14.64
|
|
Change From Baseline in Liver Function Tests
Aspartate Aminotransferase (AST) - Baseline
|
23.8 U/L
Standard Deviation 8.83
|
23.4 U/L
Standard Deviation 8.04
|
|
Change From Baseline in Liver Function Tests
Aspartate Aminotransferase (AST) - Visit 8, Day 90
|
0.8 U/L
Standard Deviation 10.96
|
1.2 U/L
Standard Deviation 8.34
|
|
Change From Baseline in Liver Function Tests
Aspartate Aminotransferase (AST) - Visit 10, Day 180
|
0.1 U/L
Standard Deviation 8.04
|
1.7 U/L
Standard Deviation 12.24
|
|
Change From Baseline in Liver Function Tests
Aspartate Aminotransferase (AST) - Visit 12, Day 270
|
0.0 U/L
Standard Deviation 9.03
|
0.3 U/L
Standard Deviation 11.27
|
|
Change From Baseline in Liver Function Tests
Aspartate Aminotransferase (AST) - Visit Day 365
|
2.2 U/L
Standard Deviation 27.18
|
1.2 U/L
Standard Deviation 9.64
|
|
Change From Baseline in Liver Function Tests
Aspartate Aminotransferase (AST) - End of Treatment
|
2.4 U/L
Standard Deviation 27.18
|
1.0 U/L
Standard Deviation 9.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.Population: Safety set
Change in bilirubin from Baseline The bilirubin test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the bilirubin value.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change in Bilirubin
Bilirubin - Baseline
|
0.491 mg/dL
Standard Deviation 0.2437
|
0.465 mg/dL
Standard Deviation 0.2561
|
|
Change in Bilirubin
Bilirubin, Visit 8 - Day 90
|
-0.088 mg/dL
Standard Deviation 0.2024
|
-0.058 mg/dL
Standard Deviation 0.2231
|
|
Change in Bilirubin
Bilirubin, Visit 10 - Day 180
|
-0.007 mg/dL
Standard Deviation 0.2350
|
-0.004 mg/dL
Standard Deviation 0.2106
|
|
Change in Bilirubin
Bilirubin, Visit 12 - Day 270
|
0.013 mg/dL
Standard Deviation 0.2254
|
0.029 mg/dL
Standard Deviation 0.2171
|
|
Change in Bilirubin
Bilirubin, Visit Day 365
|
-0.027 mg/dL
Standard Deviation 0.2155
|
0.038 mg/dL
Standard Deviation 0.2245
|
|
Change in Bilirubin
Bilirubin, End of Treatment
|
-0.032 mg/dL
Standard Deviation 0.2157
|
0.026 mg/dL
Standard Deviation 0.2117
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at the End of TreatmentPopulation: Safety Set
Hematology parameters (HbA1c) with diabetes mellitus and Without diabetes mellitus. The HbA1c test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value at End of Treatment is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the End of Treatment value. Normal range for HbA1c is 4 to 5.6%, pre-diabetic is 5.7 to 6.4%, and diabetic is equal to or greater than 6.5%.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in Hematology Parameters
HbA1c with diabetes mellitus (baseline)
|
7.20 percentage of HbA1c
Standard Deviation 0.515
|
7.07 percentage of HbA1c
Standard Deviation 0.340
|
|
Change From Baseline in Hematology Parameters
HbA1c with diabetes mellitus end of treatment
|
0.04 percentage of HbA1c
Standard Deviation 0.975
|
0.73 percentage of HbA1c
Standard Deviation 0.608
|
|
Change From Baseline in Hematology Parameters
HbA1c without diabetes mellitus (baseline)
|
5.63 percentage of HbA1c
Standard Deviation 0.432
|
5.65 percentage of HbA1c
Standard Deviation 0.469
|
|
Change From Baseline in Hematology Parameters
HbA1c without diabetes mellitus end of treatment
|
0.11 percentage of HbA1c
Standard Deviation 0.369
|
0.00 percentage of HbA1c
Standard Deviation 0.326
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of TreatmentPopulation: Safety set
Hormone levels (luteinizing hormone \[LH\], follicle-stimulating hormone \[FSH\], sex hormone-binding globulin \[SHBG\], TSH). The hormone level test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the hormone level.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in Hormone Levels
Follicle Stimulating Hormone (FSH) - Baseline
|
5.46 mIU/mL
Standard Deviation 5.496
|
5.03 mIU/mL
Standard Deviation 3.283
|
|
Change From Baseline in Hormone Levels
Follicle Stimulating Hormone (FSH) - Visit 8 - Day 90
|
-3.35 mIU/mL
Standard Deviation 4.423
|
-3.28 mIU/mL
Standard Deviation 2.888
|
|
Change From Baseline in Hormone Levels
Follicle Stimulating Hormone (FSH) - Visit Day 365
|
-2.72 mIU/mL
Standard Deviation 4.209
|
-1.82 mIU/mL
Standard Deviation 6.708
|
|
Change From Baseline in Hormone Levels
Follicle Stimulating Hormone (FSH) - Visit Day 365 End of Treatment
|
-2.45 mIU/mL
Standard Deviation 4.162
|
-1.77 mIU/mL
Standard Deviation 6.230
|
|
Change From Baseline in Hormone Levels
Luteinizing Hormone (LH) - Baseline
|
4.82 mIU/mL
Standard Deviation 3.755
|
4.58 mIU/mL
Standard Deviation 2.494
|
|
Change From Baseline in Hormone Levels
Luteinizing Hormone (LH) - Visit 8 - Day 90
|
-3.25 mIU/mL
Standard Deviation 3.805
|
-3.28 mIU/mL
Standard Deviation 2.472
|
|
Change From Baseline in Hormone Levels
Luteinizing Hormone (LH) - Visit Day 365
|
-2.53 mIU/mL
Standard Deviation 3.487
|
-1.67 mIU/mL
Standard Deviation 4.484
|
|
Change From Baseline in Hormone Levels
Luteinizing Visit Day Hormone (LH) - End of Treatment
|
-2.18 mIU/mL
Standard Deviation 3.582
|
-1.60 mIU/mL
Standard Deviation 4.272
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of TreatmentPopulation: Safety Set
Change in hormone Sex Hormone Binding Globulin (SHBG). The hormone level test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the hormone level.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change in Hormone SHBG
SHBG - Baseline
|
27.08 nmol/L
Standard Deviation 11.958
|
24.52 nmol/L
Standard Deviation 10.210
|
|
Change in Hormone SHBG
SHBG - Day 90
|
-8.99 nmol/L
Standard Deviation 8.167
|
0.26 nmol/L
Standard Deviation 4.341
|
|
Change in Hormone SHBG
SHBG - Day 365
|
-7.00 nmol/L
Standard Deviation 9.326
|
1.60 nmol/L
Standard Deviation 8.126
|
|
Change in Hormone SHBG
SHBG - End of Treatment
|
-6.25 nmol/L
Standard Deviation 9.637
|
1.39 nmol/L
Standard Deviation 7.595
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of TreatmentPopulation: Safety Set
Change from Baseline in Thyroid stimulating Hormone (TSH). The TSH test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the TSH level.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change in TSH (Thyrotropin)
Thyrotropin - Baseline
|
2.212 mU/L
Standard Deviation 1.1941
|
2.407 mU/L
Standard Deviation 1.2624
|
|
Change in TSH (Thyrotropin)
Thyrotropin - Day 90
|
0.293 mU/L
Standard Deviation 1.0140
|
0.343 mU/L
Standard Deviation 1.0773
|
|
Change in TSH (Thyrotropin)
Thyrotropin - Day 365
|
0.195 mU/L
Standard Deviation 1.1494
|
0.122 mU/L
Standard Deviation 1.0080
|
|
Change in TSH (Thyrotropin)
Thyrotropin - End of Treatment
|
0.209 mU/L
Standard Deviation 1.1204
|
0.081 mU/L
Standard Deviation 1.0571
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of TreatmentPopulation: Safety Set LDL Cholesterol, Baseline = number of subjects with non-missing results
Lipid profiles (high and low-density lipoproteins, total cholesterol, triglycerides). The lipid test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment. End of Treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the lipid value.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in Lipid Profiles
Cholesterol, Baseline
|
190.5 mg/dL
Standard Deviation 38.55
|
191.1 mg/dL
Standard Deviation 39.12
|
|
Change From Baseline in Lipid Profiles
Cholesterol, Visit 8 Day 90
|
-8.6 mg/dL
Standard Deviation 29.86
|
-6.1 mg/dL
Standard Deviation 26.36
|
|
Change From Baseline in Lipid Profiles
Cholesterol, Visit 10 Day 180
|
-10.7 mg/dL
Standard Deviation 29.56
|
-5.7 mg/dL
Standard Deviation 25.07
|
|
Change From Baseline in Lipid Profiles
Cholesterol, Visit 12 Day 270
|
-14.3 mg/dL
Standard Deviation 32.28
|
-8.2 mg/dL
Standard Deviation 31.83
|
|
Change From Baseline in Lipid Profiles
Cholesterol, Visit Day 365
|
-14.0 mg/dL
Standard Deviation 28.72
|
-5.5 mg/dL
Standard Deviation 38.41
|
|
Change From Baseline in Lipid Profiles
Cholesterol, End of Treatment
|
-11.6 mg/dL
Standard Deviation 30.56
|
-6.0 mg/dL
Standard Deviation 36.24
|
|
Change From Baseline in Lipid Profiles
HDL Cholesterol, Baseline
|
46.8 mg/dL
Standard Deviation 11.84
|
45.2 mg/dL
Standard Deviation 11.33
|
|
Change From Baseline in Lipid Profiles
HDL Cholesterol, Visit 8, Day 90
|
-7.5 mg/dL
Standard Deviation 8.45
|
-1.5 mg/dL
Standard Deviation 6.79
|
|
Change From Baseline in Lipid Profiles
HDL Cholesterol, Visit 10, Day 180
|
-6.9 mg/dL
Standard Deviation 9.96
|
-1.9 mg/dL
Standard Deviation 6.94
|
|
Change From Baseline in Lipid Profiles
HDL Cholesterol, Visit 12, Day 270
|
-6.7 mg/dL
Standard Deviation 9.53
|
-1.6 mg/dL
Standard Deviation 7.62
|
|
Change From Baseline in Lipid Profiles
HDL Cholesterol, Visit Day 365
|
-7.9 mg/dL
Standard Deviation 9.83
|
-2.8 mg/dL
Standard Deviation 7.12
|
|
Change From Baseline in Lipid Profiles
HDL Cholesterol, End of Treatment
|
-7.1 mg/dL
Standard Deviation 9.87
|
-2.8 mg/dL
Standard Deviation 7.05
|
|
Change From Baseline in Lipid Profiles
LDL Cholesterol, Baseline 1
|
110.8 mg/dL
Standard Deviation 34.72
|
108.9 mg/dL
Standard Deviation 34.39
|
|
Change From Baseline in Lipid Profiles
LDL Cholesterol, Visit 8 - Day 90
|
-0.3 mg/dL
Standard Deviation 26.13
|
-4.3 mg/dL
Standard Deviation 22.91
|
|
Change From Baseline in Lipid Profiles
LDL Cholesterol, Visit 10 - Day 180
|
-3.1 mg/dL
Standard Deviation 25.79
|
-5.4 mg/dL
Standard Deviation 21.92
|
|
Change From Baseline in Lipid Profiles
LDL Cholesterol, Visit 12 - Day 270
|
-6.1 mg/dL
Standard Deviation 27.90
|
-5.4 mg/dL
Standard Deviation 26.84
|
|
Change From Baseline in Lipid Profiles
LDL Cholesterol, Visit Day 365
|
-4.8 mg/dL
Standard Deviation 25.06
|
-5.4 mg/dL
Standard Deviation 30.42
|
|
Change From Baseline in Lipid Profiles
LDL Cholesterol, End of Treatment
|
-3.8 mg/dL
Standard Deviation 25.92
|
-5.5 mg/dL
Standard Deviation 29.41
|
|
Change From Baseline in Lipid Profiles
Triglycerides, Baseline
|
167.6 mg/dL
Standard Deviation 86.30
|
184.6 mg/dL
Standard Deviation 86.79
|
|
Change From Baseline in Lipid Profiles
Triglycerides, Visit 8 - Day 90
|
-2.5 mg/dL
Standard Deviation 86.21
|
9.4 mg/dL
Standard Deviation 100.18
|
|
Change From Baseline in Lipid Profiles
Triglycerides, Visit 10 - Day 180
|
-3.2 mg/dL
Standard Deviation 75.75
|
19.0 mg/dL
Standard Deviation 99.18
|
|
Change From Baseline in Lipid Profiles
Triglycerides, Visit 12 - Day 270
|
-8.0 mg/dL
Standard Deviation 88.60
|
15.4 mg/dL
Standard Deviation 126.56
|
|
Change From Baseline in Lipid Profiles
Triglycerides, Visit Day 365
|
-7.0 mg/dL
Standard Deviation 73.84
|
26.0 mg/dL
Standard Deviation 144.41
|
|
Change From Baseline in Lipid Profiles
Triglycerides, End of Treatment
|
-4.8 mg/dL
Standard Deviation 77.97
|
25.9 mg/dL
Standard Deviation 136.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of TreatmentPopulation: Safety Set
Serum prostate-specific antigen (PSA). The PSA results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment. End of Treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the PSA value.
Outcome measures
| Measure |
SOV2012-F1 Treated
n=214 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=100 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Change From Baseline in PSA
Prostate Specific Antigen, Baseline
|
0.87 ng/mL
Standard Deviation 0.549
|
0.78 ng/mL
Standard Deviation 0.506
|
|
Change From Baseline in PSA
Prostate Specific Antigen, Visit 8 - Day 90
|
0.18 ng/mL
Standard Deviation 0.452
|
0.18 ng/mL
Standard Deviation 0.435
|
|
Change From Baseline in PSA
Prostate Specific Antigen, Visit 10 - Day 180
|
0.20 ng/mL
Standard Deviation 0.472
|
0.22 ng/mL
Standard Deviation 0.533
|
|
Change From Baseline in PSA
Prostate Specific Antigen, Visit 12 - Day 270
|
0.25 ng/mL
Standard Deviation 0.586
|
0.29 ng/mL
Standard Deviation 0.650
|
|
Change From Baseline in PSA
Prostate Specific Antigen, Visit Day 365
|
0.23 ng/mL
Standard Deviation 0.525
|
0.27 ng/mL
Standard Deviation 0.756
|
|
Change From Baseline in PSA
Prostate Specific Antigen, End of Treatment
|
0.23 ng/mL
Standard Deviation 0.523
|
0.41 ng/mL
Standard Deviation 1.688
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 52 weeksPopulation: ACTH Completers Set
To determine the effect of SOV2012-F1 on adrenal cortical function as assessed by measuring the cortisol response to synthetic ACTH at baseline and after 52 weeks of treatment in a subset of SOV2012-F1 subjects. . The sample size was calculated based on a assumed common Standard Deviation of 93 nmol/L to yield a half-width of not more than 60 nmol/L; hence a sample size of 30 was targeted for the investigational (SOV2012-F1) arm, and 15 for the safety control arm (AndroGel).
Outcome measures
| Measure |
SOV2012-F1 Treated
n=29 Participants
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to (Days 28 and 56) up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-gel™ Treated
n=13 Participants
100 patients treated with AndroGel, according to label, using sampling on Days 14 and 42 with dose adjustment on Days 28 and 65.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Effect of SOV2012-F1 on Adrenal Cortical Function as Assessed by Measuring the Cortisol Response to Synthetic ACTH at Baseline in Subjects
Maximum Serum Cortisol (Day 1 - Baseline)
|
23.75 nmol/L
Standard Deviation 3.584
|
25.68 nmol/L
Standard Deviation 2.373
|
|
Effect of SOV2012-F1 on Adrenal Cortical Function as Assessed by Measuring the Cortisol Response to Synthetic ACTH at Baseline in Subjects
Maximum Serum Cortisol (Day 365 - End of Study)
|
25.22 nmol/L
Standard Deviation 4.561
|
27.05 nmol/L
Standard Deviation 3.267
|
Adverse Events
SOV2012-F1-Treated
Serious events: 9 serious events
Other events: 53 other events
Deaths: 1 deaths
Andro-Gel Treated
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOV2012-F1-Treated
n=214 participants at risk
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-Gel Treated
n=100 participants at risk
100 patients treated with AndroGel, according to label, using samples on Days 14 and 42 with dose adjustment on Days 28 and 56.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial infarction
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Cardiac disorders
Myocardial infarction
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Gastrointestinal disorders
Colitis
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.47%
1/214 • Number of events 2 • 365 days
|
1.0%
1/100 • Number of events 1 • 365 days
|
|
General disorders
Chest pain
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Infections and infestations
Cellulitis
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
|
Surgical and medical procedures
Finger amputation
|
0.47%
1/214 • Number of events 1 • 365 days
|
0.00%
0/100 • 365 days
|
Other adverse events
| Measure |
SOV2012-F1-Treated
n=214 participants at risk
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
SOV2012-F1: oral preparation of testosterone undecanoate (TU)
|
Andro-Gel Treated
n=100 participants at risk
100 patients treated with AndroGel, according to label, using samples on Days 14 and 42 with dose adjustment on Days 28 and 56.
AndroGel: topical testosterone gel, 1.62%
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.7%
8/214 • Number of events 9 • 365 days
|
4.0%
4/100 • Number of events 4 • 365 days
|
|
Vascular disorders
Hypertension
|
7.9%
17/214 • Number of events 19 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Vascular disorders
Flushing
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea syndrome
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/214 • 365 days
|
2.0%
2/100 • Number of events 4 • 365 days
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/214 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
General disorders
Oedema peripheral
|
2.3%
5/214 • Number of events 6 • 365 days
|
0.00%
0/100 • 365 days
|
|
General disorders
Chills
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.9%
4/214 • Number of events 4 • 365 days
|
2.0%
2/100 • Number of events 3 • 365 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.47%
1/214 • Number of events 1 • 365 days
|
3.0%
3/100 • Number of events 3 • 365 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/214 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Psychiatric disorders
Anxiety
|
2.3%
5/214 • Number of events 6 • 365 days
|
0.00%
0/100 • 365 days
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/214 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/214 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/214 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
15/214 • Number of events 20 • 365 days
|
12.0%
12/100 • Number of events 16 • 365 days
|
|
Infections and infestations
Influenza
|
4.7%
10/214 • Number of events 10 • 365 days
|
4.0%
4/100 • Number of events 4 • 365 days
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.3%
7/214 • Number of events 10 • 365 days
|
5.0%
5/100 • Number of events 6 • 365 days
|
|
Infections and infestations
Sinusitis
|
2.3%
5/214 • Number of events 5 • 365 days
|
4.0%
4/100 • Number of events 4 • 365 days
|
|
Infections and infestations
Urinary tract infection
|
0.93%
2/214 • Number of events 2 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Infections and infestations
Acute sinusitis
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Infections and infestations
Gastroenteritis
|
0.47%
1/214 • Number of events 1 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Investigations
Blood pressure increased
|
3.3%
7/214 • Number of events 9 • 365 days
|
3.0%
3/100 • Number of events 3 • 365 days
|
|
Investigations
Prostatic specific antigen increased
|
2.3%
5/214 • Number of events 5 • 365 days
|
5.0%
5/100 • Number of events 5 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
6/214 • Number of events 9 • 365 days
|
6.0%
6/100 • Number of events 7 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
6/214 • Number of events 7 • 365 days
|
1.0%
1/100 • Number of events 1 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.93%
2/214 • Number of events 2 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
1/214 • Number of events 1 • 365 days
|
3.0%
3/100 • Number of events 3 • 365 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/214 • 365 days
|
3.0%
3/100 • Number of events 5 • 365 days
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
6/214 • Number of events 6 • 365 days
|
2.0%
2/100 • Number of events 2 • 365 days
|
|
Gastrointestinal disorders
Constipation
|
2.3%
5/214 • Number of events 5 • 365 days
|
0.00%
0/100 • 365 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place