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NCT03242590 · BASELINE

Baseline characteristics

Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021). · Source last updated 2019-10-23

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
      95
    units
    Participants
groups
  1. description
    Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
    id
    BG000
    title
    Oral Testosterone Undecanoate, LPCN 1021
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.9
          value
          56.0
    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
          95
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          77
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          95
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          74.5
          value
          202
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Testosterone Value (ng/dL)
    unit Of Measure
    ng/dL
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      95
    units
    Participants
groups
  1. description
    Oral testosterone undecanoate, LPCN 1021 225 mg TU two times a day. LPCN 1021: Oral testosterone undecanoate
    id
    BG000
    title
    Oral Testosterone Undecanoate, LPCN 1021
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.9
          value
          56.0
    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
          95
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          77
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          95
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          74.5
          value
          202
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Testosterone Value (ng/dL)
    unit Of Measure
    ng/dL

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Preserved source evidence · Not medical advice