Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01697345 · BASELINE

Baseline characteristics

Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy · Source last updated 2014-01-24

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
      12
    units
    Participants
groups
  1. description
    Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
    id
    BG000
    title
    Vaginal Testosterone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.095
          value
          59.67
    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
          12
        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
          12
      title
      Married
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Not Married
    param Type
    NUMBER
    title
    Marital Status
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      0-5 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      6-10 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      11-15 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      16-20 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      21-25 years
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      26-30 years
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      31-35 years
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      36-40 years
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      41-50 years
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      51-55 years
    param Type
    NUMBER
    title
    Length of Marriage
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      High school degree
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Associate's degree
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Bachelor's degree
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Master's degree
    param Type
    NUMBER
    title
    Highest Level of Education
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      No
    param Type
    NUMBER
    title
    Oophorectomy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      ER+
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      ER-
    param Type
    NUMBER
    title
    Estrogen-receptor (ER) Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      PR+
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      PR-
    param Type
    NUMBER
    title
    Progesterone-receptor (PR) Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      HER2+
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      HER2-
    param Type
    NUMBER
    title
    Human Epidermal Growth Factor Receptor 2 (HER2) Status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      anastrozole (Arimidex)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      letrozole (Femara)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      exemestane (Aromasin)
    param Type
    NUMBER
    title
    Aromatase Inhibitor
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      No vaginal infection
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Gardnerella vaginalis
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Candidiasis species
    description
    A vaginal swab was obtained prior to prescribing testosterone therapy because women with suppressed estrogen levels have an increased risk of infection.
    param Type
    NUMBER
    title
    Vaginal Swab Test
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      No
    param Type
    NUMBER
    title
    Sexually Active Prior to Study
    unit Of Measure
    Participants
population Description
One patient withdrew due to symptoms of recurrent Gardnerella vaginalis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      12
    units
    Participants
groups
  1. description
    Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
    id
    BG000
    title
    Vaginal Testosterone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.095
          value
          59.67
    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
          12
        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
          12
      title
      Married
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Not Married
    param Type
    NUMBER
    title
    Marital Status
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      0-5 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      6-10 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      11-15 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      16-20 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      21-25 years
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      26-30 years
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      31-35 years
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      36-40 years
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      41-50 years
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      51-55 years
    param Type
    NUMBER
    title
    Length of Marriage
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      High school degree
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Associate's degree
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Bachelor's degree
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Master's degree
    param Type
    NUMBER
    title
    Highest Level of Education
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      No
    param Type
    NUMBER
    title
    Oophorectomy
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      ER+
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      ER-
    param Type
    NUMBER
    title
    Estrogen-receptor (ER) Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      PR+
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      PR-
    param Type
    NUMBER
    title
    Progesterone-receptor (PR) Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      HER2+
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      HER2-
    param Type
    NUMBER
    title
    Human Epidermal Growth Factor Receptor 2 (HER2) Status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      anastrozole (Arimidex)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      letrozole (Femara)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      exemestane (Aromasin)
    param Type
    NUMBER
    title
    Aromatase Inhibitor
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      No vaginal infection
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Gardnerella vaginalis
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Candidiasis species
    description
    A vaginal swab was obtained prior to prescribing testosterone therapy because women with suppressed estrogen levels have an increased risk of infection.
    param Type
    NUMBER
    title
    Vaginal Swab Test
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      No
    param Type
    NUMBER
    title
    Sexually Active Prior to Study
    unit Of Measure
    Participants
population Description
One patient withdrew due to symptoms of recurrent Gardnerella vaginalis.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice