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NCT01376349 · BASELINE

Baseline characteristics

Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms · Source last updated 2019-02-07

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
      147
    2. group Id
      BG001
      value
      149
    3. group Id
      BG002
      value
      147
    4. group Id
      BG003
      value
      443
    units
    Participants
groups
  1. description
    Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    BG000
    title
    Arm I Low Dose DHEA
  2. description
    Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    BG001
    title
    Arm II High Dose DHEA
  3. description
    Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. \> \> There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    BG002
    title
    Arm III Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.7
          value
          56.8
        2. group Id
          BG001
          spread
          8.2
          value
          57.3
        3. group Id
          BG002
          spread
          7.3
          value
          58
        4. group Id
          BG003
          spread
          7.4
          value
          57.3
    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
          147
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          147
        4. group Id
          BG003
          value
          443
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          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
          147
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          147
        4. group Id
          BG003
          value
          443
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
All patients that were randomized to treatment were included in baseline characteristics.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      147
    2. group Id
      BG001
      value
      149
    3. group Id
      BG002
      value
      147
    4. group Id
      BG003
      value
      443
    units
    Participants
groups
  1. description
    Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    BG000
    title
    Arm I Low Dose DHEA
  2. description
    Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    BG001
    title
    Arm II High Dose DHEA
  3. description
    Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. \> \> There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
    id
    BG002
    title
    Arm III Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.7
          value
          56.8
        2. group Id
          BG001
          spread
          8.2
          value
          57.3
        3. group Id
          BG002
          spread
          7.3
          value
          58
        4. group Id
          BG003
          spread
          7.4
          value
          57.3
    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
          147
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          147
        4. group Id
          BG003
          value
          443
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          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
          147
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          147
        4. group Id
          BG003
          value
          443
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
All patients that were randomized to treatment were included in baseline characteristics.

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Preserved source evidence · Not medical advice