Trial Outcomes & Findings for The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NCT NCT04134091)
NCT ID: NCT04134091
Last Updated: 2023-12-14
Results Overview
The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2023-12-14
Participant Flow
Participant milestones
| Measure |
Treatment A
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
19
|
|
Overall Study
Completed Week 12
|
18
|
19
|
18
|
|
Overall Study
COMPLETED
|
18
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Treatment A
n=18 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=19 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=19 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 8.66 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 10.68 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 10.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo.
Outcome measures
| Measure |
Treatment A
n=18 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=19 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=19 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
|
-7.68 Percentage of liver fat
Interval -9.82 to -5.54
|
-9.17 Percentage of liver fat
Interval -11.26 to -7.08
|
-1.54 Percentage of liver fat
Interval -3.65 to 0.58
|
SECONDARY outcome
Timeframe: Baseline and week 12Requirement for inclusion in analysis was having a baseline hepatic fat fraction ≥ 5% based on MRI-PDFF.
Outcome measures
| Measure |
Treatment A
n=17 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=17 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=18 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Relative Change in MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
|
-39.94 Percentage change
Interval -50.76 to -29.11
|
-46.84 Percentage change
Interval -57.3 to -36.38
|
-9.34 Percentage change
Interval -20.2 to 1.53
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: Number of participants reflect the participants who had NASH at baseline, as confirmed by a biopsy, and a second biopsy at week 36.
Resolution of nonalcoholic steatohepatitis (NASH) is defined as the nonalcoholic fatty liver disease activity score (NAS) score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. These data are based on the NASH-clinical research network (CRN) histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8.
Outcome measures
| Measure |
Treatment A
n=13 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=13 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=11 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Number of Participants With Resolution of NASH on Overall Histopathological Reading in LPCN 1144 Treated Subjects Compared to Placebo
|
7 Participants
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: Overall number of participants reflect the participants who had NASH at baseline, as confirmed by a biopsy, and a second biopsy at week 36.
Resolution of NASH is defined as NAS score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8. No worsening was defined as a score in fibrosis equal to, or lower, than baseline.
Outcome measures
| Measure |
Treatment A
n=13 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=13 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=11 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Number of Subjects Achieving Resolution of NASH on Overall Histopathological Reading and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.
|
6 Participants
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 36Population: Overall number of participants are based on those with a baseline and week 36 biopsy
Paired biopsies are randomly assigned A or B and are scored by a blinded pathologist as better, worse or same for change in fibrosis, steatosis, inflammation, and ballooning. Improvement in NASH requires no worsening of fibrosis, an improvement in ballooning or inflammation, and no worsening of ballooning or inflammation. Assessment of better or same is considered as no worsening.
Outcome measures
| Measure |
Treatment A
n=15 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=14 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=15 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Number of Subjects With Improvement in NASH Evaluated by Paired Biopsies Analysis and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.
|
9 Participants
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: Overall number of participants are based on those with a baseline and week 36 biopsy.
These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8.
Outcome measures
| Measure |
Treatment A
n=15 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=14 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=15 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Change in the Mean Score of NAS Components at Baseline and After 36 Weeks of Treatment in LPCN 1144 Treated Subjects Compared to Placebo.
Hepatocyte ballooning score
|
-0.7 NAS score
Interval -1.1 to -0.3
|
-0.9 NAS score
Interval -1.3 to -0.5
|
-0.2 NAS score
Interval -0.6 to 0.2
|
|
Change in the Mean Score of NAS Components at Baseline and After 36 Weeks of Treatment in LPCN 1144 Treated Subjects Compared to Placebo.
Lobular inflammation score
|
-0.2 NAS score
Interval -0.5 to 0.1
|
-0.5 NAS score
Interval -0.8 to -0.1
|
-0.1 NAS score
Interval -0.4 to 0.2
|
|
Change in the Mean Score of NAS Components at Baseline and After 36 Weeks of Treatment in LPCN 1144 Treated Subjects Compared to Placebo.
Steatosis score
|
-0.9 NAS score
Interval -1.3 to -0.6
|
-1.2 NAS score
Interval -1.6 to -0.8
|
-0.1 NAS score
Interval -0.5 to 0.2
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: Overall number of participants are based on those with a baseline and week 36 biopsy.
These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, and fibrosis stage 0-4. Improvement in liver fibrosis was defined as an improvement in fibrosis greater than or equal to one stage using the NASH CRN fibrosis score with no worsening of ballooning, inflammation, or steatosis.
Outcome measures
| Measure |
Treatment A
n=15 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=14 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=15 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Number of Subjects With an Improvement in Liver Fibrosis Greater Than or Equal to One Stage and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo.
|
4 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 36Population: Overall number of participants are based on those with a baseline and week 36 biopsy.
Paired biopsies are randomly assigned A or B and are scored by a blinded pathologist as better, worse or same for change in fibrosis, steatosis, inflammation, and ballooning. Improvement in fibrosis requires a better score in fibrosis and no worsening of ballooning or inflammation. Assessment of better or same is considered as no worsening.
Outcome measures
| Measure |
Treatment A
n=15 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=14 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=15 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Number of Subjects With Improvement in Fibrosis Evaluated by Paired Biopsies Analysis and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo
|
6 Participants
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 36Population: Overall number of participants are based on those with a baseline and week 36 biopsy.
Improvement in Fibrosis is defined as improvement in parenchymal tissue normalized phenotypic fibrosis composite value compared to baseline. FibroNest is an image analysis system for the assessment of the severity and progression of fibrosis in NASH, produced by PharmaNest LLC.
Outcome measures
| Measure |
Treatment A
n=15 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=14 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=15 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Number of Subjects With Improvement in Fibrosis Evaluated Via FibroNest Scores
|
12 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and 36 weeksRelative change in appendicular lean muscle mass measured by dual-energy absorptiometry (DXA) in LPCN 1144 treated subjects compared to Placebo. Data were last observation carried forward.
Outcome measures
| Measure |
Treatment A
n=13 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=13 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=14 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Relative Change in Appendicular Lean Muscle Mass
|
2.75 Percentage change
Interval -0.04 to 5.54
|
1.90 Percentage change
Interval -0.87 to 4.67
|
-1.42 Percentage change
Interval -4.12 to 1.28
|
SECONDARY outcome
Timeframe: Baseline and week 36Relative change in whole body fat mass measured by dual-energy absorptiometry (DXA) in LPCN 1144 treated subjects compared to Placebo. Data were last observation carried forward.
Outcome measures
| Measure |
Treatment A
n=13 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=13 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=14 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Relative Change in Whole Body Fat Mass
|
-3.68 Percentage change
Interval -9.6 to 2.24
|
-7.33 Percentage change
Interval -13.35 to -1.31
|
1.78 Percentage change
Interval -4.01 to 7.57
|
SECONDARY outcome
Timeframe: Baseline and Week 36Liver enzymes analyzed were aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT)
Outcome measures
| Measure |
Treatment A
n=18 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=17 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=17 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Mean Change From Baseline in Liver Enzymes in LPCN 1144 Treated Subjects Compared to Placebo.
Alanine transaminase (ALT)
|
-11.4 U/L
Interval -23.1 to 0.3
|
-22.9 U/L
Interval -34.5 to -11.2
|
0.6 U/L
Interval -11.3 to 12.4
|
|
Mean Change From Baseline in Liver Enzymes in LPCN 1144 Treated Subjects Compared to Placebo.
Alkaline phosphatase (ALP)
|
-6.1 U/L
Interval -11.4 to -0.9
|
-8.5 U/L
Interval -13.7 to -3.3
|
0.1 U/L
Interval -5.1 to 5.4
|
|
Mean Change From Baseline in Liver Enzymes in LPCN 1144 Treated Subjects Compared to Placebo.
Gamma-glutamyltransferase (GGT)
|
-2.9 U/L
Interval -11.4 to 5.6
|
-13.4 U/L
Interval -22.0 to -4.9
|
0.7 U/L
Interval -8.0 to 9.4
|
|
Mean Change From Baseline in Liver Enzymes in LPCN 1144 Treated Subjects Compared to Placebo.
Aspartate transaminase (AST)
|
-8.0 U/L
Interval -14.9 to -1.0
|
-12.0 U/L
Interval -18.9 to -5.1
|
1.3 U/L
Interval -5.8 to 8.3
|
SECONDARY outcome
Timeframe: Baseline and Week 36Lipid profile parameters included total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides.
Outcome measures
| Measure |
Treatment A
n=18 Participants
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=17 Participants
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=16 Participants
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Mean Changes in Serum Lipid Profile Parameters in LPCN 1144 Treated Subjects Compared to Placebo.
Total Cholesterol
|
-1.7 mg/dL
Interval -17.7 to 14.2
|
7.3 mg/dL
Interval -8.8 to 23.4
|
1.1 mg/dL
Interval -15.4 to 17.7
|
|
Mean Changes in Serum Lipid Profile Parameters in LPCN 1144 Treated Subjects Compared to Placebo.
LDL
|
1.8 mg/dL
Interval -11.4 to 15.1
|
8.7 mg/dL
Interval -3.6 to 21.1
|
-6.0 mg/dL
Interval -20.0 to 7.9
|
|
Mean Changes in Serum Lipid Profile Parameters in LPCN 1144 Treated Subjects Compared to Placebo.
HDL
|
-3.3 mg/dL
Interval -5.8 to -0.7
|
-2.0 mg/dL
Interval -4.6 to 0.6
|
-0.0 mg/dL
Interval -2.7 to 2.7
|
|
Mean Changes in Serum Lipid Profile Parameters in LPCN 1144 Treated Subjects Compared to Placebo.
Triglycerides
|
-11.5 mg/dL
Interval -78.6 to 55.6
|
-3.9 mg/dL
Interval -70.8 to 63.0
|
67.3 mg/dL
Interval -0.2 to 134.9
|
Adverse Events
Treatment A
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Treatment B
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment C
Serious events: 1 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment A
n=18 participants at risk
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=19 participants at risk
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=19 participants at risk
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Infections and infestations
Corona virus infection
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Blood and lymphatic system disorders
Polycythemia
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Cardiac disorders
Acute myocardial infarction
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Cardiac disorders
Coronary artery disease
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Endocrine disorders
Hyperprolactinemia
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
Other adverse events
| Measure |
Treatment A
n=18 participants at risk
LPCN 1144 Formulation A
LPCN 1144 Formulation A: Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
|
Treatment B
n=19 participants at risk
LPCN 1144 Formulation B
LPCN 1144 Formulation B: Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as BID (225 mg testosterone undecanoate + 238 mg d-alpha tocopherol per dose)
|
Treatment C
n=19 participants at risk
Placebo
Placebo: Oral matching placebo capsule administered as BID
|
|---|---|---|---|
|
Infections and infestations
Corona virus infection
|
11.1%
2/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
10.5%
2/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
10.5%
2/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
10.5%
2/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Infections and infestations
Influenza
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
10.5%
2/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
10.5%
2/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Gastrointestinal disorders
Oral muscosal blistering
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Investigations
Coronavirus test postive
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Investigations
Cortisol decreased
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Investigations
Glycosylated hemoglobin increased
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Investigations
Hematocrit increased
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Investigations
Prostatic specific antigen increased
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
10.5%
2/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Nervous system disorders
Sciatica
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Vascular disorders
Hypertension
|
16.7%
3/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
General disorders
Edema peripheral
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
10.5%
2/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
10.5%
2/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Cardiac disorders
Bradycardia
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalized
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Eye disorders
Retinal tear
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
5.3%
1/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
|
Endocrine disorders
Hyperprolactinemia
|
5.6%
1/18 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
0.00%
0/19 • Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place