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NCT04467697 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      155
    units
    Participants
groups
  1. 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. Doses were up-titrated at Days 28 and 56 if the measured T-concentration in a NaF/EDTA plasma sample was below 400 ng/dL; down-titrated if the T-concentration was above 900 ng/dL, and no change if between those thresholds. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
    id
    BG000
    title
    SOV2012-F1-treated
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.41
          value
          50.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          155
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          99
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          29
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          119
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      <= 93 kg
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          96
      title
      > 93 kg
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Weight at Baseline
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.343
          value
          33.95
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Low-fat breakfast
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          53
      title
      Normal-fat breakfast
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          80
      title
      High-fat breakfast
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Assigned breakfast diet
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
      title
      With Diabetes Mellitus
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          121
      title
      Without Diabetes Mellitus
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diabetic Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          96
      title
      Hypertensive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          56
      title
      Not hypertensive
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypertensive Status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
      title
      With Antihypertensive Therapy at Visit 7E (Day 1 E)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          99
      title
      Without Antihypertensive Therapy at Visit 7E (Day 1 E)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypertensive Treatment Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Primary
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          147
      title
      Secondary
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypogonadal Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      155
    units
    Participants
groups
  1. 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. Doses were up-titrated at Days 28 and 56 if the measured T-concentration in a NaF/EDTA plasma sample was below 400 ng/dL; down-titrated if the T-concentration was above 900 ng/dL, and no change if between those thresholds. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
    id
    BG000
    title
    SOV2012-F1-treated
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.41
          value
          50.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          155
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          99
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          29
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          119
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          59
      title
      <= 93 kg
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          96
      title
      > 93 kg
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Weight at Baseline
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.343
          value
          33.95
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Low-fat breakfast
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          53
      title
      Normal-fat breakfast
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          80
      title
      High-fat breakfast
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Assigned breakfast diet
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
      title
      With Diabetes Mellitus
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          121
      title
      Without Diabetes Mellitus
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diabetic Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          96
      title
      Hypertensive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          56
      title
      Not hypertensive
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypertensive Status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
      title
      With Antihypertensive Therapy at Visit 7E (Day 1 E)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          99
      title
      Without Antihypertensive Therapy at Visit 7E (Day 1 E)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypertensive Treatment Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Primary
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          147
      title
      Secondary
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hypogonadal Status
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice