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NCT01620138 · BASELINE

Baseline characteristics

Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas · Source last updated 2016-08-22

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
    2. group Id
      BG001
      value
      9
    3. group Id
      BG002
      value
      21
    units
    Participants
groups
  1. description
    For non-cured patients with resistant prolactinomas , MRI will be performed before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month. For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated clinically by MRI six months after pasireotide. Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months. The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months.
    id
    BG000
    title
    Pasireotide
  2. description
    In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose. cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months. The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months.
    id
    BG001
    title
    Cabergoline
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          63
          value
          33
        2. group Id
          BG001
          lower Limit
          36
          upper Limit
          65
          value
          54
        3. group Id
          BG002
          lower Limit
          24
          upper Limit
          65
          value
          54
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        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
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          21
      title
      Brazil
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      12
    2. group Id
      BG001
      value
      9
    3. group Id
      BG002
      value
      21
    units
    Participants
groups
  1. description
    For non-cured patients with resistant prolactinomas , MRI will be performed before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month. For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated clinically by MRI six months after pasireotide. Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months. The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months.
    id
    BG000
    title
    Pasireotide
  2. description
    In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose. cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months. The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months.
    id
    BG001
    title
    Cabergoline
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          63
          value
          33
        2. group Id
          BG001
          lower Limit
          36
          upper Limit
          65
          value
          54
        3. group Id
          BG002
          lower Limit
          24
          upper Limit
          65
          value
          54
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        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
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          21
      title
      Brazil
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice