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NCT04467697 · FLOW

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Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men · Source last updated 2024-06-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. Doses were up-titrated at Days 28 and 56 if the measured T-concentration in a NaF/EDTA plasma sample was below 400 ng/dL; down-titrated if the T-concentration was above 900 ng/dL, and no change if between those thresholds. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
    id
    FG000
    title
    SOV2012-F1-treated
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        135
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg in the morning with morning meal and 400 mg in the evening with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 mg twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. Doses were up-titrated at Days 28 and 56 if the measured T-concentration in a NaF/EDTA plasma sample was below 400 ng/dL; down-titrated if the T-concentration was above 900 ng/dL, and no change if between those thresholds. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
    id
    FG000
    title
    SOV2012-F1-treated
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        135
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice