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NCT04467697 · OUTCOME

Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
90 days

What was measured

Percentage of SOV2012-F1 treated subjects with maximum serum levels falling into three concentration groups after 90 days of treatment with SOV2012-F1.

Analysis population: Modified Extension Treatment Set

Groups in this outcome

SERUM

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 with morning meal and 400 mg 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 me twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths. Patients (n=16) from a single clinical site were excluded from PK-based outcomes due to sample handling errors. Patients were participants in the Serum sub study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
SERUM89

Reported measurements

T Cmax <=1500 ng/dL After 90 Days
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SERUM81Not reportedNot reportedNot reportedNot reported
T Cmax 1800 to 2500 ng/dL After 90 Days
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SERUM4Not reportedNot reportedNot reportedNot reported
T Cmax >2500 ng/dL After 90 Days
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
SERUM0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        81
    title
    T Cmax <=1500 ng/dL After 90 Days
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    T Cmax 1800 to 2500 ng/dL After 90 Days
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    T Cmax >2500 ng/dL After 90 Days
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    units
    Participants
description
Percentage of SOV2012-F1 treated subjects with maximum serum levels falling into three concentration groups after 90 days of treatment with SOV2012-F1.
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 with morning meal and 400 mg 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 me twice daily) or 800 mg (400 mg twice daily). All doses taken with meals. SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths. Patients (n=16) from a single clinical site were excluded from PK-based outcomes due to sample handling errors. Patients were participants in the Serum sub study.
    id
    OG000
    title
    SERUM
param Type
COUNT_OF_PARTICIPANTS
population Description
Modified Extension Treatment Set
reporting Status
POSTED
time Frame
90 days
title
Percentage of SOV2012-F1-Treated Subjects With Maximum Serum Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice