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NCT01370551 · BASELINE

Baseline characteristics

Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients · Source last updated 2024-10-15

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
      16
    units
    Participants
groups
  1. description
    Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol: 1 x 28 days, then 3x per week x 8 weeks
    id
    BG000
    title
    Gynoflor
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          63
          value
          57
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          16
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        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
          8
      title
      Belgium
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          40.9
          value
          104.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Estriol
    unit Of Measure
    pg/ml
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          48.62
          value
          107.88
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Follicule Stimulating Hormone (FSH)
    unit Of Measure
    mIU/ml
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.05
          value
          36.46
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Luteinizing hormone (LH)
    unit Of Measure
    mIU/ml
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          29.66
          value
          73.04
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Sex hormone binding globulin (SHBG)
    unit Of Measure
    nmol/l
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.4
          value
          31.2
    description
    The vaginal maturation index (VMI) was based on the percentages of superficial (X3) and intermediate (X2) epithelial cells present in the vaginal smear, and was calculated according to the following formula: VMI= 0.5(X2) + 1(X3)
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Vaginal maturation index (VMI)
    unit Of Measure
    %
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.3
          value
          3.9
    description
    LBG I Normal Predominantly lactobacillary morphotypes with few coccoid bacteria, LBG IIa Slightly disturbed Slightly disturbed, fairly normal, LBG IIb Moderately disturbed Moderately disturbed, rather abnormal, LBG III Abnormal Abundant other bacteria but no or few Lactobacilli present For the analysis, each of the categories were assigned a numeric score (LBG I= 1, LBG IIa= 2, LBG IIb= 3, LBG III= 4) where lower values indicate a better outcome
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Lactobacillary grade (LBG)
    unit Of Measure
    units on a scale
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.4
          value
          0.1
    description
    * Score 0: no BV flora present * Score 1: partial BV * Score 2: full BV
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Bacterial vaginosis (BV) score
    unit Of Measure
    units on a scale
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      16
    units
    Participants
groups
  1. description
    Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol: 1 x 28 days, then 3x per week x 8 weeks
    id
    BG000
    title
    Gynoflor
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          63
          value
          57
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          16
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        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
          8
      title
      Belgium
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          40.9
          value
          104.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Estriol
    unit Of Measure
    pg/ml
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          48.62
          value
          107.88
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Follicule Stimulating Hormone (FSH)
    unit Of Measure
    mIU/ml
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.05
          value
          36.46
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Luteinizing hormone (LH)
    unit Of Measure
    mIU/ml
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          29.66
          value
          73.04
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Sex hormone binding globulin (SHBG)
    unit Of Measure
    nmol/l
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.4
          value
          31.2
    description
    The vaginal maturation index (VMI) was based on the percentages of superficial (X3) and intermediate (X2) epithelial cells present in the vaginal smear, and was calculated according to the following formula: VMI= 0.5(X2) + 1(X3)
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Vaginal maturation index (VMI)
    unit Of Measure
    %
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.3
          value
          3.9
    description
    LBG I Normal Predominantly lactobacillary morphotypes with few coccoid bacteria, LBG IIa Slightly disturbed Slightly disturbed, fairly normal, LBG IIb Moderately disturbed Moderately disturbed, rather abnormal, LBG III Abnormal Abundant other bacteria but no or few Lactobacilli present For the analysis, each of the categories were assigned a numeric score (LBG I= 1, LBG IIa= 2, LBG IIb= 3, LBG III= 4) where lower values indicate a better outcome
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Lactobacillary grade (LBG)
    unit Of Measure
    units on a scale
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.4
          value
          0.1
    description
    * Score 0: no BV flora present * Score 1: partial BV * Score 2: full BV
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Bacterial vaginosis (BV) score
    unit Of Measure
    units on a scale

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Preserved source evidence · Not medical advice