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NCT04493333 · BASELINE

Baseline characteristics

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors · Source last updated 2024-11-27

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
      5
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      8
    units
    Participants
groups
  1. description
    Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).
    id
    BG000
    title
    Intrarosa & Standard of Care Aromatase Inhibitor
  2. description
    Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
    id
    BG001
    title
    Replens & Standard of Care Aromatase Inhibitor
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.96
          value
          57.8
        2. group Id
          BG001
          spread
          15.39
          value
          54.00
        3. group Id
          BG002
          spread
          8.98
          value
          56.38
    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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.65
          value
          50.83
        2. group Id
          BG001
          spread
          23.23
          value
          36.67
        3. group Id
          BG002
          spread
          19.67
          value
          43.75
    description
    VMI is a clinical measure of vaginal estrogenization, indicator of the degree of vaginal atrophy which is the end result of treatment with aromatase inhibitors that leads to vaginal dryness and dyspareunia. VMI is the proportional relationship of parabasal (P) cells to intermediate (I) and superficial (S) cells in the vaginal epithelium. VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is VMI=%S + (0.5 x %I) when simplified, potential range of 0-100. A VMI of 65-100 suggests a normal premenopausal environment, 50-64 indicates a moderate estrogenic effect, and \<50 indicates atrophy.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Vaginal Maturation Index (VMI)
    unit Of Measure
    Units on a scale
population Description
Postmenopausal females between 18 and 70 with a history of breast cancer.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      8
    units
    Participants
groups
  1. description
    Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).
    id
    BG000
    title
    Intrarosa & Standard of Care Aromatase Inhibitor
  2. description
    Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
    id
    BG001
    title
    Replens & Standard of Care Aromatase Inhibitor
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.96
          value
          57.8
        2. group Id
          BG001
          spread
          15.39
          value
          54.00
        3. group Id
          BG002
          spread
          8.98
          value
          56.38
    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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.65
          value
          50.83
        2. group Id
          BG001
          spread
          23.23
          value
          36.67
        3. group Id
          BG002
          spread
          19.67
          value
          43.75
    description
    VMI is a clinical measure of vaginal estrogenization, indicator of the degree of vaginal atrophy which is the end result of treatment with aromatase inhibitors that leads to vaginal dryness and dyspareunia. VMI is the proportional relationship of parabasal (P) cells to intermediate (I) and superficial (S) cells in the vaginal epithelium. VMI = 1.0 x %S + 0.5 x %I + 0.0 x %P cells, which is VMI=%S + (0.5 x %I) when simplified, potential range of 0-100. A VMI of 65-100 suggests a normal premenopausal environment, 50-64 indicates a moderate estrogenic effect, and \<50 indicates atrophy.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Vaginal Maturation Index (VMI)
    unit Of Measure
    Units on a scale
population Description
Postmenopausal females between 18 and 70 with a history of breast cancer.

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Preserved source evidence · Not medical advice