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NCT02210689 · BASELINE

Baseline characteristics

A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women · Source last updated 2020-01-28

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
      233
    2. group Id
      BG001
      value
      236
    3. group Id
      BG002
      value
      122
    4. group Id
      BG003
      value
      591
    units
    Participants
groups
  1. description
    One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
    id
    BG000
    title
    Generic Clindamycin Phosphate Vaginal Cream 2%
  2. description
    One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
    id
    BG001
    title
    Clindesse (Clindamycin Phosphate Vaginal Cream 2%)
  3. description
    One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
    id
    BG002
    title
    Vehicle Cream
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.66
          value
          34.5
        2. group Id
          BG001
          spread
          10.2
          value
          35.8
        3. group Id
          BG002
          spread
          10.17
          value
          35.1
        4. group Id
          BG003
          spread
          9.98
          value
          35.1
    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
          233
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          122
        4. group Id
          BG003
          value
          591
        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
          45
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          120
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          187
        3. group Id
          BG002
          value
          96
        4. group Id
          BG003
          value
          471
        title
        Not Hispanic or Latino
      3. 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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          16
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          255
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          304
        title
        White
      6. 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
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          122
        4. group Id
          BG003
          value
          591
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Participants who received the study drug (Safety Population)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      233
    2. group Id
      BG001
      value
      236
    3. group Id
      BG002
      value
      122
    4. group Id
      BG003
      value
      591
    units
    Participants
groups
  1. description
    One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
    id
    BG000
    title
    Generic Clindamycin Phosphate Vaginal Cream 2%
  2. description
    One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
    id
    BG001
    title
    Clindesse (Clindamycin Phosphate Vaginal Cream 2%)
  3. description
    One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.
    id
    BG002
    title
    Vehicle Cream
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.66
          value
          34.5
        2. group Id
          BG001
          spread
          10.2
          value
          35.8
        3. group Id
          BG002
          spread
          10.17
          value
          35.1
        4. group Id
          BG003
          spread
          9.98
          value
          35.1
    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
          233
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          122
        4. group Id
          BG003
          value
          591
        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
          45
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          120
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          187
        3. group Id
          BG002
          value
          96
        4. group Id
          BG003
          value
          471
        title
        Not Hispanic or Latino
      3. 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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          16
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          55
        4. group Id
          BG003
          value
          255
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          58
        4. group Id
          BG003
          value
          304
        title
        White
      6. 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
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          233
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          122
        4. group Id
          BG003
          value
          591
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Participants who received the study drug (Safety Population)

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Preserved source evidence · Not medical advice