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NCT02159469 · FLOW

Participant flow

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism · Source last updated 2018-02-07

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

groups
  1. description
    Testosterone enanthate 50 mg / 75 mg / 100 mg dose administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
    id
    FG000
    title
    QST 50 mg / 75 mg / 100 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Missing Completion status
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Non-compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Sponsor's request
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Met Stopping Criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other
    9. reasons
      1. group Id
        FG000
        num Subjects
        29
      type
      Multiple
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        150
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        137
      type
      Completed 12 Week
    3. achievements
      1. group Id
        FG000
        num Subjects
        97
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        53
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study was designed to ensure a minimum of 100 patients completed a collection of 26 weeks of safety data, and a minimum of 50 patients completed a collection of 52 weeks of safety data. Minimum enrollment goals were exceeded.
recruitment Details
Approximately 150 patients were enrolled in this study. 128 patients completed through at least Week 26, 98 patients completed through Week 52, and 97 patients completed the full study (through the Follow-up Visit).
Complete source fields
groups
  1. description
    Testosterone enanthate 50 mg / 75 mg / 100 mg dose administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
    id
    FG000
    title
    QST 50 mg / 75 mg / 100 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Missing Completion status
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Non-compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Sponsor's request
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Met Stopping Criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other
    9. reasons
      1. group Id
        FG000
        num Subjects
        29
      type
      Multiple
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        150
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        137
      type
      Completed 12 Week
    3. achievements
      1. group Id
        FG000
        num Subjects
        97
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        53
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study was designed to ensure a minimum of 100 patients completed a collection of 26 weeks of safety data, and a minimum of 50 patients completed a collection of 52 weeks of safety data. Minimum enrollment goals were exceeded.
recruitment Details
Approximately 150 patients were enrolled in this study. 128 patients completed through at least Week 26, 98 patients completed through Week 52, and 97 patients completed the full study (through the Follow-up Visit).

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Preserved source evidence · Not medical advice