TriangleNCT04467697 · OUTCOME
Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 90 days
What was measured
Percentage of SOV2012-F1 treated subjects with maximum NaF/EDTA plasma T levels falling into three concentration groups after 90 days of treatment with SOV2012-F1.
Analysis population: Modified Extension Treatment Set
Groups in this outcome
NaF/EDTA PLASMA
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 with morning meal and 400 mg 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 me 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. Patients (n=16) from a single clinical site were excluded from PK-based outcomes due to sample handling errors.
| Group | Source count |
|---|---|
| NaF/EDTA PLASMA | 139 |
Reported measurements
Plasma T Cmax <=1200 ng/dL after 90days
| Group | Source count |
|---|---|
| NaF/EDTA PLASMA | 130 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NaF/EDTA PLASMA | 114 | Not reported | Not reported | Not reported | Not reported |
Plasma T Cmax <=1440 ng/dL to 2000 ng/dL after 90days
| Group | Source count |
|---|---|
| NaF/EDTA PLASMA | 130 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NaF/EDTA PLASMA | 5 | Not reported | Not reported | Not reported | Not reported |
Plasma T Cmax >2000 ng/dL after 90days
| Group | Source count |
|---|---|
| NaF/EDTA PLASMA | 130 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NaF/EDTA PLASMA | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 114
- denoms
- counts
- group Id
- OG000
- value
- 130
- units
- Participants
- title
- Plasma T Cmax <=1200 ng/dL after 90days
- categories
- measurements
- group Id
- OG000
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 130
- units
- Participants
- title
- Plasma T Cmax <=1440 ng/dL to 2000 ng/dL after 90days
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 130
- units
- Participants
- title
- Plasma T Cmax >2000 ng/dL after 90days
- denoms
- counts
- group Id
- OG000
- value
- 139
- units
- Participants
- description
- Percentage of SOV2012-F1 treated subjects with maximum NaF/EDTA plasma T levels falling into three concentration groups after 90 days of treatment with SOV2012-F1.
- 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 with morning meal and 400 mg 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 me 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. Patients (n=16) from a single clinical site were excluded from PK-based outcomes due to sample handling errors.
- id
- OG000
- title
- NaF/EDTA PLASMA
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Modified Extension Treatment Set
- reporting Status
- POSTED
- time Frame
- 90 days
- title
- Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice