NCT04467697 · OUTCOME

Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration

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: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: 90 days

What was measured

Percentage of SOV2012-F1-treated subjects with a plasma NaF/EDTA plasma testosterone (T) Cavg within the normal range after 90 days of treatment using up- and down-titration as appropriate. Measured by Plasma T concentration using a starting daily dose of 400 mg SOV2012-F1.

Analysis population: Modified Extension Treated Set

Groups in this outcome

NaF/EDTA PLASMA

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.

SERUM

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

Analysis denominator · Participants

Group	Source count
NaF/EDTA PLASMA	139
SERUM	89

Reported measurements

Worst case scenario

Analysis denominator · Participants

Group	Source count
NaF/EDTA PLASMA	139
SERUM	89

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NaF/EDTA PLASMA	87.8	Not reported	82.3	93.2	Not reported
SERUM	86.5	Not reported	79.4	93.6	Not reported

Day 90 completers

Analysis denominator · Participants

Group	Source count
NaF/EDTA PLASMA	127
SERUM	88

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
NaF/EDTA PLASMA	96.1	Not reported	92.7	99.4	Not reported
SERUM	87.5	Not reported	80.6	94.4	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
82.3
upper Limit
93.2
value
87.8
group Id
OG001
lower Limit
79.4
upper Limit
93.6
value
86.5
denoms
counts
group Id
OG000
value
139
group Id
OG001
value
89
units
Participants
title
Worst case scenario
categories
measurements
group Id
OG000
lower Limit
92.7
upper Limit
99.4
value
96.1
group Id
OG001
lower Limit
80.6
upper Limit
94.4
value
87.5
denoms
counts
group Id
OG000
value
127
group Id
OG001
value
88
units
Participants
title
Day 90 completers

denoms

counts
group Id
OG000
value
139
group Id
OG001
value
89
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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.
id
OG000
title
NaF/EDTA PLASMA
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 enrolled in the serum sub study.
id
OG001
title
SERUM

param Type

NUMBER

population Description

Modified Extension Treated Set

reporting Status

POSTED

time Frame

90 days

title

Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration

type

PRIMARY

unit Of Measure

percentage of participants

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