NCT04467697 · OUTCOME
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men · Source last updated 2024-06-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- U/L
- Interval / dispersion
- Standard Deviation
- Time frame
- 90 and 180 days
What was measured
Alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of Units per Liter (U/L)
Analysis population: Extension Treated Set
Groups in this outcome
SOV2012-F1-treated, Observed
Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
SOV2012-F1-treated, Change From Baseline
Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 155 |
|---|
| SOV2012-F1-treated, Change From Baseline | 155 |
|---|
Reported measurements
Alkaline Phosphatase, Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 155 |
|---|
| SOV2012-F1-treated, Change From Baseline | 155 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 72.5 | 22.90 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | 0 | 0 | Not reported | Not reported | Not reported |
|---|
Alkaline Phosphatase, Visit 12E - Day 90E
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 143 |
|---|
| SOV2012-F1-treated, Change From Baseline | 143 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 70.4 | 50.29 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | -2.2 | 33.68 | Not reported | Not reported | Not reported |
|---|
Alkaline Phosphatase, Visit 16E - EOT Day 180E
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 135 |
|---|
| SOV2012-F1-treated, Change From Baseline | 135 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 65.0 | 18.43 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | -5.7 | 10.60 | Not reported | Not reported | Not reported |
|---|
Alanine Aminotransferase (ALT), Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 155 |
|---|
| SOV2012-F1-treated, Change From Baseline | 155 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 32.0 | 15.15 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | 0 | 0 | Not reported | Not reported | Not reported |
|---|
Alanine Aminotransferase (ALT), Visit 12E - Day 90E
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 143 |
|---|
| SOV2012-F1-treated, Change From Baseline | 143 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 26.5 | 12.10 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | -5.1 | 13.37 | Not reported | Not reported | Not reported |
|---|
Alanine Aminotransferase (ALT), Visit 16E - Day 180E
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 134 |
|---|
| SOV2012-F1-treated, Change From Baseline | 134 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 26.9 | 14.18 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | -4.2 | 14.46 | Not reported | Not reported | Not reported |
|---|
Aspartate Aminotransferase (AST), Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 155 |
|---|
| SOV2012-F1-treated, Change From Baseline | 155 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 24.1 | 13.48 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | 0 | 0 | Not reported | Not reported | Not reported |
|---|
Aspartate Aminotransferase (AST), Visit 12E - Day 90E
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 143 |
|---|
| SOV2012-F1-treated, Change From Baseline | 143 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 22.5 | 9.36 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | -1.4 | 14.26 | Not reported | Not reported | Not reported |
|---|
Aspartate Aminotransferase (AST), Visit 16E - Day 180E
Analysis denominator · Participants
| Group | Source count |
|---|
| SOV2012-F1-treated, Observed | 134 |
|---|
| SOV2012-F1-treated, Change From Baseline | 134 |
|---|
Values in U/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| SOV2012-F1-treated, Observed | 21.6 | 8.73 | Not reported | Not reported | Not reported |
|---|
| SOV2012-F1-treated, Change From Baseline | -1.9 | 13.28 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 22.90
- value
- 72.5
- group Id
- OG001
- spread
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 155
- units
- Participants
- title
- Alkaline Phosphatase, Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 50.29
- value
- 70.4
- group Id
- OG001
- spread
- 33.68
- value
- -2.2
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 143
- units
- Participants
- title
- Alkaline Phosphatase, Visit 12E - Day 90E
- categories
- measurements
- group Id
- OG000
- spread
- 18.43
- value
- 65.0
- group Id
- OG001
- spread
- 10.60
- value
- -5.7
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 135
- units
- Participants
- title
- Alkaline Phosphatase, Visit 16E - EOT Day 180E
- categories
- measurements
- group Id
- OG000
- spread
- 15.15
- value
- 32.0
- group Id
- OG001
- spread
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 155
- units
- Participants
- title
- Alanine Aminotransferase (ALT), Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 12.10
- value
- 26.5
- group Id
- OG001
- spread
- 13.37
- value
- -5.1
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 143
- units
- Participants
- title
- Alanine Aminotransferase (ALT), Visit 12E - Day 90E
- categories
- measurements
- group Id
- OG000
- spread
- 14.18
- value
- 26.9
- group Id
- OG001
- spread
- 14.46
- value
- -4.2
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 134
- units
- Participants
- title
- Alanine Aminotransferase (ALT), Visit 16E - Day 180E
- categories
- measurements
- group Id
- OG000
- spread
- 13.48
- value
- 24.1
- group Id
- OG001
- spread
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 155
- units
- Participants
- title
- Aspartate Aminotransferase (AST), Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 9.36
- value
- 22.5
- group Id
- OG001
- spread
- 14.26
- value
- -1.4
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 143
- units
- Participants
- title
- Aspartate Aminotransferase (AST), Visit 12E - Day 90E
- categories
- measurements
- group Id
- OG000
- spread
- 8.73
- value
- 21.6
- group Id
- OG001
- spread
- 13.28
- value
- -1.9
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 134
- units
- Participants
- title
- Aspartate Aminotransferase (AST), Visit 16E - Day 180E
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 155
- units
- Participants
- description
- Alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of Units per Liter (U/L)
- dispersion Type
- Standard Deviation
- groups
- description
- Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
- id
- OG000
- title
- SOV2012-F1-treated, Observed
- description
- Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
- id
- OG001
- title
- SOV2012-F1-treated, Change From Baseline
- param Type
- MEAN
- population Description
- Extension Treated Set
- reporting Status
- POSTED
- time Frame
- 90 and 180 days
- title
- Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- U/L
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Preserved source evidence · Not medical advice
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