Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01422408 · BASELINE

Baseline characteristics

Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy · Source last updated 2017-08-09

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
      34
    units
    Participants
groups
  1. description
    This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
    id
    BG000
    title
    Supportive Care
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          29
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.39
          value
          55.44
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        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
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Pre-menopausal
      2. measurements
        1. group Id
          BG000
          value
          33
        title
        Post-menopausal
    description
    Pre-menopausal versus post-menopausal (defined as either no menses ≥ 12 months, medical ovarian suppression with leuprolide or goserelin, bilateral ovarian ablation with radiation, or bilateral oophorectomy) The subject's menopausal status will be classified according to the menopausal status at the time of enrollment on study.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Menopause status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Anastrazole
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Exemestane
      3. measurements
        1. group Id
          BG000
          value
          13
        title
        Letrozole
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        Tamoxifen
    description
    type of endocrine therapy currently taken by the subject tamoxifen vs. anastrazole vs. letrozole vs. exemestane
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Current endocrine therapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Prior cytotoxic chemotherapy
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        No prior cytotoxic chemotherapy
    description
    Whether the subject has received prior cytotoxic chemotherapy for breast cancer: prior cytotoxic chemotherapy versus no prior cytotoxic chemotherapy for breast cancer
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior cytotoxic chemotherapy received
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        title
        Adjuvant
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Prophylaxis
    description
    use of endocrine therapy for preventative treatment with an increased risk for breast cancer vs. adjuvant treatment for a history of invasive breast cancer
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Indications for endocrine therapy
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Severe
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Not severe
    description
    Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Severe baseline symptoms, Dryness
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Severe
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Not severe
      3. measurements
        1. group Id
          BG000
          value
          9
        title
        Missing/not reported
    description
    Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Severe baseline symptoms, Dyspareunia
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Severe
      2. measurements
        1. group Id
          BG000
          value
          33
        title
        Not severe
    description
    Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Severe baseline symptoms, Itching
    unit Of Measure
    Participants
population Description
An intent-to-treat analysis set will include those who are enrolled in the trial regardless of the number of treatments received. All primary analyses will be conducted using the intent-to-treat analysis set. A safety analysis set will include those who receive at least one treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      34
    units
    Participants
groups
  1. description
    This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
    id
    BG000
    title
    Supportive Care
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          29
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.39
          value
          55.44
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        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
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Pre-menopausal
      2. measurements
        1. group Id
          BG000
          value
          33
        title
        Post-menopausal
    description
    Pre-menopausal versus post-menopausal (defined as either no menses ≥ 12 months, medical ovarian suppression with leuprolide or goserelin, bilateral ovarian ablation with radiation, or bilateral oophorectomy) The subject's menopausal status will be classified according to the menopausal status at the time of enrollment on study.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Menopause status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Anastrazole
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Exemestane
      3. measurements
        1. group Id
          BG000
          value
          13
        title
        Letrozole
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        Tamoxifen
    description
    type of endocrine therapy currently taken by the subject tamoxifen vs. anastrazole vs. letrozole vs. exemestane
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Current endocrine therapy
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Prior cytotoxic chemotherapy
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        No prior cytotoxic chemotherapy
    description
    Whether the subject has received prior cytotoxic chemotherapy for breast cancer: prior cytotoxic chemotherapy versus no prior cytotoxic chemotherapy for breast cancer
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior cytotoxic chemotherapy received
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        title
        Adjuvant
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Prophylaxis
    description
    use of endocrine therapy for preventative treatment with an increased risk for breast cancer vs. adjuvant treatment for a history of invasive breast cancer
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Indications for endocrine therapy
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Severe
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Not severe
    description
    Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Severe baseline symptoms, Dryness
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Severe
      2. measurements
        1. group Id
          BG000
          value
          10
        title
        Not severe
      3. measurements
        1. group Id
          BG000
          value
          9
        title
        Missing/not reported
    description
    Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Severe baseline symptoms, Dyspareunia
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        Severe
      2. measurements
        1. group Id
          BG000
          value
          33
        title
        Not severe
    description
    Severe symptoms indicated by a score of 3 or 4. Measured at study baseline
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Severe baseline symptoms, Itching
    unit Of Measure
    Participants
population Description
An intent-to-treat analysis set will include those who are enrolled in the trial regardless of the number of treatments received. All primary analyses will be conducted using the intent-to-treat analysis set. A safety analysis set will include those who receive at least one treatment.

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

Preserved source evidence · Not medical advice