Trial Outcomes & Findings for Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men (NCT NCT04467697)
NCT ID: NCT04467697
Last Updated: 2024-06-28
Results Overview
Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
155 participants
Primary outcome timeframe
120 days
Results posted on
2024-06-28
Participant Flow
Participant milestones
| Measure |
SOV2012-F1-treated
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.
|
|---|---|
|
Overall Study
STARTED
|
155
|
|
Overall Study
COMPLETED
|
135
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
SOV2012-F1-treated
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.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Protocol Violation
|
3
|
Baseline Characteristics
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
Baseline characteristics by cohort
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
|
|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 9.41 • n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
|
Weight at Baseline
<= 93 kg
|
59 Participants
n=39 Participants
|
|
Weight at Baseline
> 93 kg
|
96 Participants
n=39 Participants
|
|
Body Mass Index (BMI)
|
33.95 kg/m^2
STANDARD_DEVIATION 7.343 • n=39 Participants
|
|
Assigned breakfast diet
Low-fat breakfast
|
13 Participants
n=39 Participants
|
|
Assigned breakfast diet
Normal-fat breakfast
|
53 Participants
n=39 Participants
|
|
Assigned breakfast diet
High-fat breakfast
|
80 Participants
n=39 Participants
|
|
Assigned breakfast diet
Missing
|
9 Participants
n=39 Participants
|
|
Diabetic Status
With Diabetes Mellitus
|
34 Participants
n=39 Participants
|
|
Diabetic Status
Without Diabetes Mellitus
|
121 Participants
n=39 Participants
|
|
Hypertensive Status
Hypertensive
|
96 Participants
n=39 Participants
|
|
Hypertensive Status
Not hypertensive
|
56 Participants
n=39 Participants
|
|
Hypertensive Status
Missing
|
3 Participants
n=39 Participants
|
|
Hypertensive Treatment Status
With Antihypertensive Therapy at Visit 7E (Day 1 E)
|
56 Participants
n=39 Participants
|
|
Hypertensive Treatment Status
Without Antihypertensive Therapy at Visit 7E (Day 1 E)
|
99 Participants
n=39 Participants
|
|
Hypogonadal Status
Primary
|
8 Participants
n=39 Participants
|
|
Hypogonadal Status
Secondary
|
147 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 120 daysPopulation: Extension Treated Set
Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis).
Outcome measures
| Measure |
SOV2012-F1-treated
n=139 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
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 enrolled in the serum sub study.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment
Baseline
|
128.9 mmHg
Interval 126.8 to 131.0
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment
Observed Visit 14E - Day 120E
|
130.6 mmHg
Interval 128.5 to 132.7
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment
Change from baseline (Visit 14E - Day 120E)
|
1.7 mmHg
Interval 0.3 to 3.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Modified Extension Treated Set
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.
Outcome measures
| Measure |
SOV2012-F1-treated
n=139 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=89 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration
Worst case scenario
|
87.8 percentage of participants
Interval 82.3 to 93.2
|
86.5 percentage of participants
Interval 79.4 to 93.6
|
—
|
—
|
—
|
|
Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration
Day 90 completers
|
96.1 percentage of participants
Interval 92.7 to 99.4
|
87.5 percentage of participants
Interval 80.6 to 94.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 120 and 180 daysPopulation: Extension Treated Set
Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average systolic blood pressure (sBP) after 120 and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis).
Outcome measures
| Measure |
SOV2012-F1-treated
n=139 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
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 enrolled in the serum sub study.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
Baseline
|
128.9 mmHg
Interval 126.8 to 131.0
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
Observed Visit 14E (Day 120E)
|
130.6 mmHg
Interval 128.5 to 132.7
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
Change from baseline (Day 120E - Day 1E)
|
1.7 mmHg
Interval 0.3 to 3.1
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
Observed Visit 16E (Day 180E)
|
130.7 mmHg
Interval 128.6 to 132.8
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
Change from baseline (Day 180E - Day 1E)
|
1.8 mmHg
Interval 0.3 to 3.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 120 and 180 daysPopulation: Extension Treated Set
Ambulatory Blood Pressure Monitoring (ABPM) of the change from baseline in 24-hour average diastolic blood pressure (dBP) after 120 Days (+/-) and 180 (+/-) 3 days of treatment (Mixed Model Repeated Measures analysis).
Outcome measures
| Measure |
SOV2012-F1-treated
n=139 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
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 enrolled in the serum sub study.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
Baseline
|
76.2 mmHg
Interval 74.6 to 77.9
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
Observed Visit 14E (Day 120E)
|
76.9 mmHg
Interval 75.3 to 78.5
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
Change from Baseline to Visit 14E (Day 120E)
|
0.6 mmHg
Interval -0.3 to 1.6
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
Observed Visit 16E (Day 180E)
|
76.9 mmHg
Interval 75.2 to 78.5
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
Change from Baseline to Visit 16E (Day 180E)
|
0.6 mmHg
Interval -0.4 to 1.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 120 and 180 daysPopulation: Extension Treated Set
Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis.
Outcome measures
| Measure |
SOV2012-F1-treated
n=139 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
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 enrolled in the serum sub study.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
Baseline
|
76.3 bpm
Interval 74.4 to 78.3
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
Observed Visit 14E (Day 120E)
|
77.0 bpm
Interval 75.1 to 79.0
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
Change from baseline to Visit 14E (Day 120E)
|
0.7 bpm
Interval -0.5 to 1.9
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
Observed Visit 16E (Day 180E)
|
78.2 bpm
Interval 76.2 to 80.2
|
—
|
—
|
—
|
—
|
|
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
Change from baseline to Visit 16E (Day 180E)
|
1.9 bpm
Interval 0.6 to 3.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 120 and 180 daysPopulation: Extension Treated Set
Observed and change from baseline in Ambulatory half hourly systolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
n=155 Participants
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
n=155 Participants
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
n=155 Participants
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
0 hours
|
133.3 mmHg
Standard Deviation 12.02
|
133.7 mmHg
Standard Deviation 12.90
|
0.7 mmHg
Standard Deviation 13.90
|
133.1 mmHg
Standard Deviation 11.95
|
-0.0 mmHg
Standard Deviation 13.17
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
0.5 hours
|
135.6 mmHg
Standard Deviation 15.23
|
134.2 mmHg
Standard Deviation 13.87
|
-0.6 mmHg
Standard Deviation 13.70
|
133.1 mmHg
Standard Deviation 12.22
|
-2.2 mmHg
Standard Deviation 15.53
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
1 hour
|
133.9 mmHg
Standard Deviation 15.28
|
133.9 mmHg
Standard Deviation 13.53
|
0.4 mmHg
Standard Deviation 15.54
|
135.5 mmHg
Standard Deviation 13.07
|
1.7 mmHg
Standard Deviation 16.52
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
1.5 hours
|
132.3 mmHg
Standard Deviation 15.32
|
132.8 mmHg
Standard Deviation 13.76
|
0.9 mmHg
Standard Deviation 14.80
|
133.5 mmHg
Standard Deviation 13.75
|
1.6 mmHg
Standard Deviation 16.49
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
2 hours
|
131.9 mmHg
Standard Deviation 15.60
|
132.7 mmHg
Standard Deviation 14.17
|
1.9 mmHg
Standard Deviation 16.23
|
132.6 mmHg
Standard Deviation 15.87
|
1.7 mmHg
Standard Deviation 18.07
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
2.5 hours
|
130.9 mmHg
Standard Deviation 15.29
|
132.6 mmHg
Standard Deviation 15.86
|
1.8 mmHg
Standard Deviation 16.23
|
132.5 mmHg
Standard Deviation 14.08
|
2.4 mmHg
Standard Deviation 16.15
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
3 hours
|
130.9 mmHg
Standard Deviation 15.84
|
131.2 mmHg
Standard Deviation 15.86
|
1.0 mmHg
Standard Deviation 18.59
|
132.2 mmHg
Standard Deviation 14.62
|
1.9 mmHg
Standard Deviation 19.28
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
3.5 hours
|
130.6 mmHg
Standard Deviation 15.54
|
131.5 mmHg
Standard Deviation 16.28
|
1.0 mmHg
Standard Deviation 18.33
|
131.5 mmHg
Standard Deviation 16.53
|
2.0 mmHg
Standard Deviation 17.44
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
4 hours
|
130.7 mmHg
Standard Deviation 14.42
|
133.2 mmHg
Standard Deviation 15.35
|
2.2 mmHg
Standard Deviation 14.82
|
131.9 mmHg
Standard Deviation 15.72
|
2.3 mmHg
Standard Deviation 14.91
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
4.5 hours
|
130.5 mmHg
Standard Deviation 15.73
|
131.5 mmHg
Standard Deviation 15.78
|
1.0 mmHg
Standard Deviation 15.69
|
132.4 mmHg
Standard Deviation 14.70
|
2.6 mmHg
Standard Deviation 15.20
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
5 hours
|
129.3 mmHg
Standard Deviation 15.69
|
133.5 mmHg
Standard Deviation 16.69
|
4.8 mmHg
Standard Deviation 17.57
|
130.8 mmHg
Standard Deviation 15.98
|
2.2 mmHg
Standard Deviation 16.13
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
5.5 hours
|
130.8 mmHg
Standard Deviation 16.20
|
133.8 mmHg
Standard Deviation 16.34
|
3.4 mmHg
Standard Deviation 18.06
|
132.4 mmHg
Standard Deviation 16.83
|
2.5 mmHg
Standard Deviation 17.31
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
6 hours
|
130.9 mmHg
Standard Deviation 16.68
|
133.2 mmHg
Standard Deviation 14.86
|
3.2 mmHg
Standard Deviation 16.16
|
132.2 mmHg
Standard Deviation 16.08
|
2.5 mmHg
Standard Deviation 17.79
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
6.5 hours
|
131.2 mmHg
Standard Deviation 17.44
|
132.4 mmHg
Standard Deviation 15.72
|
2.1 mmHg
Standard Deviation 19.08
|
131.4 mmHg
Standard Deviation 16.31
|
1.6 mmHg
Standard Deviation 19.24
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
7 hours
|
131.8 mmHg
Standard Deviation 16.52
|
133.0 mmHg
Standard Deviation 16.16
|
1.3 mmHg
Standard Deviation 17.51
|
129.7 mmHg
Standard Deviation 15.41
|
-0.9 mmHg
Standard Deviation 16.11
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
7.5 hours
|
131.5 mmHg
Standard Deviation 17.07
|
133.3 mmHg
Standard Deviation 15.53
|
1.6 mmHg
Standard Deviation 17.44
|
132.2 mmHg
Standard Deviation 13.53
|
1.2 mmHg
Standard Deviation 17.22
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
8 hours
|
132.6 mmHg
Standard Deviation 15.63
|
132.3 mmHg
Standard Deviation 13.22
|
-0.8 mmHg
Standard Deviation 16.38
|
131.9 mmHg
Standard Deviation 13.98
|
-0.2 mmHg
Standard Deviation 15.65
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
8.5 hours
|
133.6 mmHg
Standard Deviation 15.24
|
133.7 mmHg
Standard Deviation 14.74
|
0.7 mmHg
Standard Deviation 16.51
|
131.2 mmHg
Standard Deviation 13.51
|
-1.4 mmHg
Standard Deviation 14.26
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
9 hours
|
133.7 mmHg
Standard Deviation 15.37
|
134.0 mmHg
Standard Deviation 15.99
|
0.6 mmHg
Standard Deviation 16.46
|
131.4 mmHg
Standard Deviation 14.44
|
-1.4 mmHg
Standard Deviation 16.61
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
9.5 hours
|
133.0 mmHg
Standard Deviation 16.47
|
134.7 mmHg
Standard Deviation 15.24
|
1.5 mmHg
Standard Deviation 17.82
|
131.8 mmHg
Standard Deviation 15.67
|
-0.4 mmHg
Standard Deviation 15.64
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
10 hours
|
132.5 mmHg
Standard Deviation 16.52
|
133.6 mmHg
Standard Deviation 15.09
|
1.4 mmHg
Standard Deviation 17.78
|
134.2 mmHg
Standard Deviation 15.35
|
1.6 mmHg
Standard Deviation 18.16
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
10.5 hours
|
133.3 mmHg
Standard Deviation 16.54
|
134.9 mmHg
Standard Deviation 17.51
|
1.5 mmHg
Standard Deviation 18.15
|
133.0 mmHg
Standard Deviation 13.51
|
-0.3 mmHg
Standard Deviation 16.86
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
11 hours
|
132.1 mmHg
Standard Deviation 15.55
|
134.9 mmHg
Standard Deviation 15.43
|
2.6 mmHg
Standard Deviation 16.27
|
132.0 mmHg
Standard Deviation 13.45
|
0.7 mmHg
Standard Deviation 16.09
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
11.5 hours
|
131.4 mmHg
Standard Deviation 15.99
|
133.5 mmHg
Standard Deviation 14.61
|
1.9 mmHg
Standard Deviation 16.23
|
132.7 mmHg
Standard Deviation 14.42
|
1.7 mmHg
Standard Deviation 15.13
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
12 hours
|
129.8 mmHg
Standard Deviation 15.25
|
132.6 mmHg
Standard Deviation 15.45
|
2.7 mmHg
Standard Deviation 16.85
|
131.7 mmHg
Standard Deviation 14.92
|
2.7 mmHg
Standard Deviation 18.01
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
12.5 hours
|
129.5 mmHg
Standard Deviation 15.29
|
131.4 mmHg
Standard Deviation 15.81
|
2.4 mmHg
Standard Deviation 18.09
|
131.7 mmHg
Standard Deviation 14.19
|
3.4 mmHg
Standard Deviation 16.25
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
13 hours
|
126.9 mmHg
Standard Deviation 16.11
|
131.4 mmHg
Standard Deviation 16.17
|
5.3 mmHg
Standard Deviation 17.42
|
130.9 mmHg
Standard Deviation 16.12
|
5.3 mmHg
Standard Deviation 18.77
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
13.5 hours
|
126.7 mmHg
Standard Deviation 15.55
|
130.1 mmHg
Standard Deviation 17.21
|
3.3 mmHg
Standard Deviation 18.80
|
131.0 mmHg
Standard Deviation 16.29
|
4.6 mmHg
Standard Deviation 18.61
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
14 hours
|
125.1 mmHg
Standard Deviation 16.69
|
127.8 mmHg
Standard Deviation 15.68
|
2.9 mmHg
Standard Deviation 18.06
|
128.0 mmHg
Standard Deviation 16.68
|
2.8 mmHg
Standard Deviation 20.12
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
14.5 hours
|
123.7 mmHg
Standard Deviation 16.27
|
127.2 mmHg
Standard Deviation 16.38
|
3.2 mmHg
Standard Deviation 17.49
|
126.7 mmHg
Standard Deviation 16.22
|
3.4 mmHg
Standard Deviation 19.46
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
15 hours
|
122.4 mmHg
Standard Deviation 15.78
|
125.7 mmHg
Standard Deviation 16.48
|
3.5 mmHg
Standard Deviation 18.12
|
127.1 mmHg
Standard Deviation 17.74
|
4.3 mmHg
Standard Deviation 16.45
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
15.5 hours
|
121.1 mmHg
Standard Deviation 16.98
|
124.2 mmHg
Standard Deviation 16.92
|
3.1 mmHg
Standard Deviation 18.83
|
125.4 mmHg
Standard Deviation 18.38
|
3.6 mmHg
Standard Deviation 20.19
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
16 hours
|
119.2 mmHg
Standard Deviation 16.09
|
122.0 mmHg
Standard Deviation 15.24
|
2.3 mmHg
Standard Deviation 17.88
|
123.4 mmHg
Standard Deviation 14.40
|
3.8 mmHg
Standard Deviation 15.77
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
16.5 hours
|
116.8 mmHg
Standard Deviation 16.02
|
120.5 mmHg
Standard Deviation 16.58
|
3.9 mmHg
Standard Deviation 16.94
|
121.4 mmHg
Standard Deviation 14.99
|
4.5 mmHg
Standard Deviation 17.09
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
17 hours
|
116.9 mmHg
Standard Deviation 15.07
|
118.4 mmHg
Standard Deviation 16.39
|
1.0 mmHg
Standard Deviation 17.28
|
120.7 mmHg
Standard Deviation 16.51
|
3.3 mmHg
Standard Deviation 17.81
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
17.5 hours
|
117.4 mmHg
Standard Deviation 15.03
|
118.4 mmHg
Standard Deviation 16.00
|
0.5 mmHg
Standard Deviation 16.84
|
119.8 mmHg
Standard Deviation 16.35
|
2.1 mmHg
Standard Deviation 15.50
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
18 hours
|
116.4 mmHg
Standard Deviation 15.44
|
118.0 mmHg
Standard Deviation 16.12
|
1.3 mmHg
Standard Deviation 17.87
|
118.6 mmHg
Standard Deviation 15.26
|
2.6 mmHg
Standard Deviation 17.10
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
18.5 hours
|
117.7 mmHg
Standard Deviation 15.18
|
117.4 mmHg
Standard Deviation 16.31
|
0.1 mmHg
Standard Deviation 16.51
|
118.5 mmHg
Standard Deviation 15.02
|
2.3 mmHg
Standard Deviation 15.92
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
19 hours
|
116.1 mmHg
Standard Deviation 14.22
|
117.2 mmHg
Standard Deviation 15.37
|
1.1 mmHg
Standard Deviation 16.02
|
118.1 mmHg
Standard Deviation 16.61
|
1.9 mmHg
Standard Deviation 16.23
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
19.5 hours
|
116.5 mmHg
Standard Deviation 15.54
|
118.5 mmHg
Standard Deviation 15.24
|
2.4 mmHg
Standard Deviation 16.40
|
117.9 mmHg
Standard Deviation 16.19
|
2.0 mmHg
Standard Deviation 16.59
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
20 hours
|
117.4 mmHg
Standard Deviation 16.25
|
117.7 mmHg
Standard Deviation 16.48
|
0.6 mmHg
Standard Deviation 16.77
|
119.0 mmHg
Standard Deviation 15.33
|
1.1 mmHg
Standard Deviation 14.78
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
20.5 hours
|
118.2 mmHg
Standard Deviation 16.81
|
117.9 mmHg
Standard Deviation 16.29
|
0.4 mmHg
Standard Deviation 18.78
|
120.2 mmHg
Standard Deviation 17.50
|
1.9 mmHg
Standard Deviation 16.49
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
21 hours
|
118.4 mmHg
Standard Deviation 15.85
|
120.7 mmHg
Standard Deviation 16.36
|
1.7 mmHg
Standard Deviation 19.28
|
121.2 mmHg
Standard Deviation 16.42
|
2.0 mmHg
Standard Deviation 17.72
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
21.5 hours
|
123.0 mmHg
Standard Deviation 15.13
|
121.8 mmHg
Standard Deviation 16.57
|
-1.1 mmHg
Standard Deviation 17.92
|
124.7 mmHg
Standard Deviation 16.86
|
1.9 mmHg
Standard Deviation 17.95
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
22 hours
|
123.8 mmHg
Standard Deviation 16.88
|
124.1 mmHg
Standard Deviation 15.37
|
0.9 mmHg
Standard Deviation 18.73
|
126.0 mmHg
Standard Deviation 15.12
|
3.2 mmHg
Standard Deviation 17.04
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
22.5 hours
|
127.1 mmHg
Standard Deviation 17.61
|
129.5 mmHg
Standard Deviation 15.39
|
3.3 mmHg
Standard Deviation 17.35
|
128.3 mmHg
Standard Deviation 16.56
|
4.6 mmHg
Standard Deviation 16.98
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
23 hours
|
129.1 mmHg
Standard Deviation 16.44
|
129.4 mmHg
Standard Deviation 15.25
|
0.4 mmHg
Standard Deviation 17.41
|
132.6 mmHg
Standard Deviation 15.73
|
4.8 mmHg
Standard Deviation 16.49
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
23.5 hours
|
131.0 mmHg
Standard Deviation 13.83
|
130.4 mmHg
Standard Deviation 13.41
|
-0.9 mmHg
Standard Deviation 13.66
|
131.6 mmHg
Standard Deviation 14.62
|
0.9 mmHg
Standard Deviation 15.08
|
SECONDARY outcome
Timeframe: 120 and 180 daysPopulation: Extension Treated Set
Observed and change from baseline in Ambulatory half hourly diastolic blood pressure as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
n=155 Participants
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
n=155 Participants
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
n=155 Participants
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
18 hours
|
67.7 mmHg
Standard Deviation 12.63
|
68.9 mmHg
Standard Deviation 11.62
|
0.9 mmHg
Standard Deviation 13.79
|
68.0 mmHg
Standard Deviation 12.20
|
0.5 mmHg
Standard Deviation 14.84
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
0 hours
|
83.7 mmHg
Standard Deviation 9.78
|
83.9 mmHg
Standard Deviation 10.09
|
0.6 mmHg
Standard Deviation 9.90
|
83.3 mmHg
Standard Deviation 9.16
|
0.1 mmHg
Standard Deviation 9.51
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
0.5 hours
|
83.5 mmHg
Standard Deviation 11.71
|
82.2 mmHg
Standard Deviation 10.36
|
-1.0 mmHg
Standard Deviation 11.35
|
82.9 mmHg
Standard Deviation 10.30
|
-0.2 mmHg
Standard Deviation 11.42
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
1 hour
|
81.7 mmHg
Standard Deviation 11.42
|
82.0 mmHg
Standard Deviation 11.10
|
0.3 mmHg
Standard Deviation 12.69
|
82.9 mmHg
Standard Deviation 11.19
|
1.4 mmHg
Standard Deviation 12.38
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
1.5 hours
|
80.9 mmHg
Standard Deviation 12.37
|
80.8 mmHg
Standard Deviation 10.80
|
0.6 mmHg
Standard Deviation 10.81
|
81.1 mmHg
Standard Deviation 10.97
|
1.2 mmHg
Standard Deviation 12.32
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
2 hours
|
81.2 mmHg
Standard Deviation 11.66
|
80.4 mmHg
Standard Deviation 12.83
|
0.4 mmHg
Standard Deviation 12.91
|
79.8 mmHg
Standard Deviation 10.62
|
-0.0 mmHg
Standard Deviation 12.29
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
2.5 hours
|
79.0 mmHg
Standard Deviation 11.54
|
79.4 mmHg
Standard Deviation 12.28
|
0.7 mmHg
Standard Deviation 15.36
|
80.2 mmHg
Standard Deviation 11.05
|
1.6 mmHg
Standard Deviation 13.62
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
3 hours
|
78.9 mmHg
Standard Deviation 12.13
|
79.0 mmHg
Standard Deviation 12.82
|
-0.1 mmHg
Standard Deviation 14.34
|
79.5 mmHg
Standard Deviation 11.60
|
0.5 mmHg
Standard Deviation 14.85
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
3.5 hours
|
79.8 mmHg
Standard Deviation 12.56
|
79.9 mmHg
Standard Deviation 12.25
|
-0.2 mmHg
Standard Deviation 14.17
|
79.1 mmHg
Standard Deviation 11.75
|
-0.2 mmHg
Standard Deviation 12.58
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
4 hours
|
79.1 mmHg
Standard Deviation 11.36
|
80.7 mmHg
Standard Deviation 11.87
|
1.2 mmHg
Standard Deviation 12.19
|
79.2 mmHg
Standard Deviation 11.17
|
0.5 mmHg
Standard Deviation 10.83
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
4.5 hours
|
79.6 mmHg
Standard Deviation 12.55
|
79.3 mmHg
Standard Deviation 12.48
|
-0.5 mmHg
Standard Deviation 12.84
|
79.3 mmHg
Standard Deviation 10.53
|
0.2 mmHg
Standard Deviation 12.21
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
5 hours
|
78.1 mmHg
Standard Deviation 13.51
|
79.9 mmHg
Standard Deviation 12.15
|
2.2 mmHg
Standard Deviation 13.74
|
78.3 mmHg
Standard Deviation 12.22
|
0.9 mmHg
Standard Deviation 12.21
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
5.5 hours
|
77.8 mmHg
Standard Deviation 12.39
|
80.9 mmHg
Standard Deviation 14.40
|
3.3 mmHg
Standard Deviation 14.05
|
78.9 mmHg
Standard Deviation 12.41
|
1.5 mmHg
Standard Deviation 13.31
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
6 hours
|
79.5 mmHg
Standard Deviation 12.94
|
79.5 mmHg
Standard Deviation 12.27
|
0.1 mmHg
Standard Deviation 12.22
|
78.3 mmHg
Standard Deviation 11.47
|
-0.5 mmHg
Standard Deviation 13.33
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
6.5 hours
|
78.5 mmHg
Standard Deviation 12.89
|
78.8 mmHg
Standard Deviation 11.51
|
0.3 mmHg
Standard Deviation 13.18
|
79.1 mmHg
Standard Deviation 12.72
|
1.3 mmHg
Standard Deviation 14.39
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
7 hours
|
78.5 mmHg
Standard Deviation 12.96
|
78.9 mmHg
Standard Deviation 11.75
|
-0.0 mmHg
Standard Deviation 11.94
|
77.9 mmHg
Standard Deviation 11.92
|
0.3 mmHg
Standard Deviation 12.75
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
7.5 hours
|
79.5 mmHg
Standard Deviation 13.48
|
79.5 mmHg
Standard Deviation 12.69
|
0.4 mmHg
Standard Deviation 14.08
|
79.2 mmHg
Standard Deviation 11.82
|
-0.0 mmHg
Standard Deviation 12.66
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
8 hours
|
80.3 mmHg
Standard Deviation 12.73
|
79.2 mmHg
Standard Deviation 11.24
|
-1.5 mmHg
Standard Deviation 13.63
|
78.9 mmHg
Standard Deviation 11.10
|
-0.7 mmHg
Standard Deviation 12.71
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
8.5 hours
|
80.1 mmHg
Standard Deviation 12.22
|
80.3 mmHg
Standard Deviation 11.82
|
0.8 mmHg
Standard Deviation 12.80
|
78.9 mmHg
Standard Deviation 10.52
|
-0.6 mmHg
Standard Deviation 12.20
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
9 hours
|
81.0 mmHg
Standard Deviation 12.64
|
80.6 mmHg
Standard Deviation 12.26
|
0.2 mmHg
Standard Deviation 12.77
|
79.1 mmHg
Standard Deviation 11.75
|
-1.6 mmHg
Standard Deviation 13.58
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
9.5 hours
|
80.3 mmHg
Standard Deviation 13.11
|
80.4 mmHg
Standard Deviation 12.24
|
0.1 mmHg
Standard Deviation 13.46
|
79.8 mmHg
Standard Deviation 11.99
|
0.4 mmHg
Standard Deviation 14.33
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
10 hours
|
81.1 mmHg
Standard Deviation 12.61
|
80.5 mmHg
Standard Deviation 11.79
|
-0.6 mmHg
Standard Deviation 12.75
|
80.4 mmHg
Standard Deviation 12.45
|
-0.5 mmHg
Standard Deviation 13.58
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
10.5 hours
|
80.4 mmHg
Standard Deviation 12.48
|
79.9 mmHg
Standard Deviation 12.02
|
-0.3 mmHg
Standard Deviation 13.59
|
79.8 mmHg
Standard Deviation 11.75
|
-0.5 mmHg
Standard Deviation 12.65
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
11 hours
|
79.2 mmHg
Standard Deviation 11.71
|
80.0 mmHg
Standard Deviation 12.01
|
0.6 mmHg
Standard Deviation 12.60
|
79.1 mmHg
Standard Deviation 12.60
|
0.2 mmHg
Standard Deviation 13.38
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
11.5 hours
|
79.1 mmHg
Standard Deviation 12.48
|
79.3 mmHg
Standard Deviation 11.81
|
-0.4 mmHg
Standard Deviation 12.44
|
77.7 mmHg
Standard Deviation 12.77
|
-0.8 mmHg
Standard Deviation 12.62
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
12 hours
|
77.6 mmHg
Standard Deviation 12.75
|
79.8 mmHg
Standard Deviation 11.25
|
1.9 mmHg
Standard Deviation 12.60
|
77.7 mmHg
Standard Deviation 12.12
|
0.1 mmHg
Standard Deviation 14.20
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
12.5 hours
|
78.3 mmHg
Standard Deviation 13.37
|
78.4 mmHg
Standard Deviation 11.90
|
0.2 mmHg
Standard Deviation 13.96
|
77.5 mmHg
Standard Deviation 11.80
|
-0.3 mmHg
Standard Deviation 13.59
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
13 hours
|
75.1 mmHg
Standard Deviation 12.71
|
76.9 mmHg
Standard Deviation 12.52
|
2.4 mmHg
Standard Deviation 12.37
|
76.3 mmHg
Standard Deviation 12.20
|
2.3 mmHg
Standard Deviation 13.55
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
13.5 hours
|
75.0 mmHg
Standard Deviation 12.23
|
76.7 mmHg
Standard Deviation 13.26
|
1.9 mmHg
Standard Deviation 14.89
|
76.2 mmHg
Standard Deviation 11.72
|
1.5 mmHg
Standard Deviation 14.28
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
14 hours
|
73.1 mmHg
Standard Deviation 12.93
|
74.4 mmHg
Standard Deviation 11.73
|
1.4 mmHg
Standard Deviation 14.13
|
74.0 mmHg
Standard Deviation 12.41
|
0.6 mmHg
Standard Deviation 15.89
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
14.5 hours
|
72.3 mmHg
Standard Deviation 12.97
|
74.2 mmHg
Standard Deviation 12.82
|
1.6 mmHg
Standard Deviation 14.56
|
73.0 mmHg
Standard Deviation 11.84
|
1.1 mmHg
Standard Deviation 14.22
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
15 hours
|
70.7 mmHg
Standard Deviation 12.39
|
72.5 mmHg
Standard Deviation 12.36
|
2.1 mmHg
Standard Deviation 14.20
|
74.3 mmHg
Standard Deviation 12.43
|
3.8 mmHg
Standard Deviation 13.00
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
15.5 hours
|
69.8 mmHg
Standard Deviation 13.53
|
71.8 mmHg
Standard Deviation 12.22
|
1.6 mmHg
Standard Deviation 16.12
|
72.5 mmHg
Standard Deviation 13.17
|
2.3 mmHg
Standard Deviation 15.89
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
16 hours
|
68.3 mmHg
Standard Deviation 13.06
|
70.5 mmHg
Standard Deviation 12.46
|
1.5 mmHg
Standard Deviation 15.77
|
71.0 mmHg
Standard Deviation 11.59
|
1.9 mmHg
Standard Deviation 13.87
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
16.5 hours
|
67.7 mmHg
Standard Deviation 12.71
|
69.8 mmHg
Standard Deviation 11.20
|
2.1 mmHg
Standard Deviation 13.03
|
69.9 mmHg
Standard Deviation 12.66
|
2.4 mmHg
Standard Deviation 15.69
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
17 hours
|
67.2 mmHg
Standard Deviation 11.77
|
69.1 mmHg
Standard Deviation 12.04
|
1.8 mmHg
Standard Deviation 13.27
|
69.6 mmHg
Standard Deviation 12.38
|
2.6 mmHg
Standard Deviation 14.27
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
17.5 hours
|
67.6 mmHg
Standard Deviation 11.91
|
69.3 mmHg
Standard Deviation 12.42
|
1.2 mmHg
Standard Deviation 14.70
|
69.0 mmHg
Standard Deviation 12.62
|
0.8 mmHg
Standard Deviation 13.16
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
18.5 hours
|
68.3 mmHg
Standard Deviation 11.82
|
68.6 mmHg
Standard Deviation 11.46
|
0.2 mmHg
Standard Deviation 13.77
|
68.4 mmHg
Standard Deviation 12.08
|
0.7 mmHg
Standard Deviation 12.81
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
19 hours
|
67.6 mmHg
Standard Deviation 11.78
|
68.3 mmHg
Standard Deviation 11.14
|
0.7 mmHg
Standard Deviation 12.97
|
69.2 mmHg
Standard Deviation 12.48
|
1.2 mmHg
Standard Deviation 12.54
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
19.5 hours
|
67.9 mmHg
Standard Deviation 11.62
|
69.4 mmHg
Standard Deviation 12.85
|
1.5 mmHg
Standard Deviation 13.41
|
68.9 mmHg
Standard Deviation 13.12
|
1.2 mmHg
Standard Deviation 12.89
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
20 hours
|
69.6 mmHg
Standard Deviation 12.43
|
68.5 mmHg
Standard Deviation 12.95
|
-1.3 mmHg
Standard Deviation 13.93
|
69.8 mmHg
Standard Deviation 12.88
|
-0.4 mmHg
Standard Deviation 13.50
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
20.5 hours
|
69.8 mmHg
Standard Deviation 13.04
|
68.9 mmHg
Standard Deviation 12.56
|
-0.8 mmHg
Standard Deviation 14.42
|
69.9 mmHg
Standard Deviation 13.25
|
-0.2 mmHg
Standard Deviation 13.22
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
21 hours
|
70.3 mmHg
Standard Deviation 13.04
|
70.8 mmHg
Standard Deviation 13.56
|
0.1 mmHg
Standard Deviation 15.23
|
72.8 mmHg
Standard Deviation 13.05
|
1.9 mmHg
Standard Deviation 14.26
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
21.5 hours
|
73.8 mmHg
Standard Deviation 13.00
|
72.6 mmHg
Standard Deviation 14.23
|
-1.4 mmHg
Standard Deviation 15.16
|
74.8 mmHg
Standard Deviation 13.79
|
1.0 mmHg
Standard Deviation 15.12
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
22 hours
|
74.9 mmHg
Standard Deviation 13.38
|
74.3 mmHg
Standard Deviation 13.15
|
-0.0 mmHg
Standard Deviation 15.63
|
76.2 mmHg
Standard Deviation 12.44
|
2.4 mmHg
Standard Deviation 13.20
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
22.5 hours
|
77.8 mmHg
Standard Deviation 13.39
|
80.4 mmHg
Standard Deviation 13.33
|
3.6 mmHg
Standard Deviation 14.74
|
77.5 mmHg
Standard Deviation 12.74
|
2.3 mmHg
Standard Deviation 11.92
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
23 hours
|
80.6 mmHg
Standard Deviation 12.53
|
79.3 mmHg
Standard Deviation 13.72
|
-0.8 mmHg
Standard Deviation 13.52
|
81.6 mmHg
Standard Deviation 12.13
|
1.7 mmHg
Standard Deviation 12.87
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
23.5 hours
|
81.8 mmHg
Standard Deviation 11.05
|
82.1 mmHg
Standard Deviation 12.17
|
0.3 mmHg
Standard Deviation 12.82
|
80.6 mmHg
Standard Deviation 10.98
|
-0.3 mmHg
Standard Deviation 11.30
|
SECONDARY outcome
Timeframe: 120 and 180 daysPopulation: Extension Treated Set
Observed and change from baseline in Ambulatory half hourly heart rate as measured by ABPM after 120 Days (+/-3) and after 180 Days (+/-3) of SOV2012-F1 treatment.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
n=155 Participants
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
n=155 Participants
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
n=155 Participants
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
15.5 hours
|
72.0 bpm
Standard Deviation 12.06
|
73.3 bpm
Standard Deviation 12.41
|
1.1 bpm
Standard Deviation 12.61
|
72.9 bpm
Standard Deviation 12.71
|
1.1 bpm
Standard Deviation 12.61
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
21.5 hours
|
69.9 bpm
Standard Deviation 13.57
|
68.2 bpm
Standard Deviation 11.52
|
-1.4 bpm
Standard Deviation 14.26
|
71.6 bpm
Standard Deviation 13.75
|
1.4 bpm
Standard Deviation 13.83
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
0 hours
|
72.6 bpm
Standard Deviation 10.22
|
74.5 bpm
Standard Deviation 10.15
|
2.3 bpm
Standard Deviation 9.72
|
74.5 bpm
Standard Deviation 11.63
|
3.0 bpm
Standard Deviation 10.17
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
0.5 hours
|
76.0 bpm
Standard Deviation 12.94
|
77.6 bpm
Standard Deviation 12.70
|
0.5 bpm
Standard Deviation 11.06
|
78.1 bpm
Standard Deviation 14.86
|
3.4 bpm
Standard Deviation 14.24
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
1 hour
|
77.7 bpm
Standard Deviation 15.77
|
80.4 bpm
Standard Deviation 13.03
|
2.4 bpm
Standard Deviation 16.11
|
81.1 bpm
Standard Deviation 16.17
|
4.5 bpm
Standard Deviation 18.28
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
1.5 hours
|
79.9 bpm
Standard Deviation 12.93
|
80.8 bpm
Standard Deviation 16.36
|
1.4 bpm
Standard Deviation 16.77
|
83.1 bpm
Standard Deviation 14.84
|
3.6 bpm
Standard Deviation 15.81
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
2 hours
|
80.7 bpm
Standard Deviation 15.79
|
80.8 bpm
Standard Deviation 13.53
|
0.8 bpm
Standard Deviation 16.59
|
82.9 bpm
Standard Deviation 15.78
|
3.6 bpm
Standard Deviation 16.50
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
2.5 hours
|
79.4 bpm
Standard Deviation 14.63
|
80.3 bpm
Standard Deviation 14.60
|
0.7 bpm
Standard Deviation 15.94
|
82.8 bpm
Standard Deviation 15.84
|
4.4 bpm
Standard Deviation 15.38
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
3 hours
|
79.0 bpm
Standard Deviation 13.08
|
79.5 bpm
Standard Deviation 13.15
|
0.2 bpm
Standard Deviation 14.08
|
80.3 bpm
Standard Deviation 15.85
|
2.7 bpm
Standard Deviation 14.96
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
3.5 hours
|
79.3 bpm
Standard Deviation 15.29
|
80.1 bpm
Standard Deviation 13.81
|
0.4 bpm
Standard Deviation 18.50
|
79.9 bpm
Standard Deviation 16.20
|
2.3 bpm
Standard Deviation 18.42
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
4 hours
|
78.4 bpm
Standard Deviation 14.73
|
79.7 bpm
Standard Deviation 14.59
|
1.1 bpm
Standard Deviation 15.37
|
80.1 bpm
Standard Deviation 16.23
|
2.8 bpm
Standard Deviation 18.74
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
4.5 hours
|
79.1 bpm
Standard Deviation 15.18
|
79.2 bpm
Standard Deviation 13.65
|
0.4 bpm
Standard Deviation 16.29
|
79.9 bpm
Standard Deviation 15.05
|
3.0 bpm
Standard Deviation 16.75
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
10 hours
|
81.8 bpm
Standard Deviation 16.28
|
80.6 bpm
Standard Deviation 15.75
|
-1.0 bpm
Standard Deviation 15.28
|
82.1 bpm
Standard Deviation 14.95
|
1.1 bpm
Standard Deviation 16.53
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
5 hours
|
79.0 bpm
Standard Deviation 15.42
|
80.5 bpm
Standard Deviation 14.79
|
1.2 bpm
Standard Deviation 16.09
|
79.7 bpm
Standard Deviation 15.39
|
2.9 bpm
Standard Deviation 14.93
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
5.5 hours
|
78.5 bpm
Standard Deviation 14.56
|
80.6 bpm
Standard Deviation 13.19
|
1.9 bpm
Standard Deviation 15.36
|
81.0 bpm
Standard Deviation 16.05
|
4.0 bpm
Standard Deviation 16.48
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
6 hours
|
79.3 bpm
Standard Deviation 14.41
|
80.5 bpm
Standard Deviation 13.26
|
1.2 bpm
Standard Deviation 15.46
|
80.4 bpm
Standard Deviation 14.02
|
2.9 bpm
Standard Deviation 15.49
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
6.5 hours
|
79.2 bpm
Standard Deviation 15.03
|
80.1 bpm
Standard Deviation 14.40
|
1.5 bpm
Standard Deviation 14.90
|
80.4 bpm
Standard Deviation 13.94
|
3.2 bpm
Standard Deviation 15.91
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
7 hours
|
80.6 bpm
Standard Deviation 15.04
|
80.9 bpm
Standard Deviation 13.85
|
0.8 bpm
Standard Deviation 14.83
|
79.8 bpm
Standard Deviation 13.27
|
0.6 bpm
Standard Deviation 15.44
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
7.5 hours
|
80.0 bpm
Standard Deviation 14.51
|
79.5 bpm
Standard Deviation 13.66
|
-0.3 bpm
Standard Deviation 15.20
|
81.1 bpm
Standard Deviation 14.52
|
2.4 bpm
Standard Deviation 14.98
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
8 hours
|
81.5 bpm
Standard Deviation 14.63
|
80.8 bpm
Standard Deviation 14.18
|
-0.9 bpm
Standard Deviation 15.86
|
80.8 bpm
Standard Deviation 14.34
|
0.5 bpm
Standard Deviation 15.15
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
8.5 hours
|
80.0 bpm
Standard Deviation 14.09
|
79.9 bpm
Standard Deviation 14.41
|
-0.1 bpm
Standard Deviation 13.89
|
79.9 bpm
Standard Deviation 13.34
|
0.6 bpm
Standard Deviation 14.18
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
9 hours
|
80.1 bpm
Standard Deviation 13.86
|
80.9 bpm
Standard Deviation 14.06
|
0.2 bpm
Standard Deviation 14.70
|
82.2 bpm
Standard Deviation 13.93
|
2.5 bpm
Standard Deviation 15.45
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
9.5 hours
|
79.9 bpm
Standard Deviation 14.21
|
80.1 bpm
Standard Deviation 16.09
|
-0.1 bpm
Standard Deviation 14.18
|
81.8 bpm
Standard Deviation 13.70
|
2.1 bpm
Standard Deviation 16.58
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
10.5 hours
|
80.4 bpm
Standard Deviation 14.75
|
78.4 bpm
Standard Deviation 13.73
|
-2.2 bpm
Standard Deviation 13.59
|
80.7 bpm
Standard Deviation 13.82
|
1.2 bpm
Standard Deviation 15.30
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
11 hours
|
79.9 bpm
Standard Deviation 14.07
|
80.5 bpm
Standard Deviation 15.79
|
0.3 bpm
Standard Deviation 14.52
|
80.8 bpm
Standard Deviation 13.14
|
2.0 bpm
Standard Deviation 13.84
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
11.5 hours
|
79.8 bpm
Standard Deviation 14.31
|
79.4 bpm
Standard Deviation 14.58
|
-1.0 bpm
Standard Deviation 16.26
|
80.2 bpm
Standard Deviation 15.05
|
0.9 bpm
Standard Deviation 14.64
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
12 hours
|
79.5 bpm
Standard Deviation 13.80
|
79.3 bpm
Standard Deviation 15.02
|
-0.5 bpm
Standard Deviation 15.77
|
79.8 bpm
Standard Deviation 14.57
|
1.2 bpm
Standard Deviation 13.92
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
12.5 hours
|
78.8 bpm
Standard Deviation 13.66
|
79.1 bpm
Standard Deviation 15.12
|
0.7 bpm
Standard Deviation 15.81
|
78.9 bpm
Standard Deviation 14.33
|
0.8 bpm
Standard Deviation 13.62
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
13 hours
|
76.4 bpm
Standard Deviation 12.04
|
77.6 bpm
Standard Deviation 13.23
|
1.7 bpm
Standard Deviation 13.59
|
77.8 bpm
Standard Deviation 14.49
|
2.3 bpm
Standard Deviation 14.37
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
13.5 hours
|
75.8 bpm
Standard Deviation 12.05
|
77.6 bpm
Standard Deviation 13.90
|
2.3 bpm
Standard Deviation 14.01
|
78.1 bpm
Standard Deviation 15.15
|
3.7 bpm
Standard Deviation 14.77
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
14 hours
|
75.6 bpm
Standard Deviation 12.47
|
75.5 bpm
Standard Deviation 13.44
|
0.1 bpm
Standard Deviation 13.93
|
75.9 bpm
Standard Deviation 13.63
|
1.0 bpm
Standard Deviation 13.19
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
14.5 hours
|
73.3 bpm
Standard Deviation 12.74
|
75.5 bpm
Standard Deviation 12.80
|
2.0 bpm
Standard Deviation 13.70
|
75.1 bpm
Standard Deviation 13.76
|
2.3 bpm
Standard Deviation 14.03
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
15 hours
|
72.5 bpm
Standard Deviation 11.47
|
74.5 bpm
Standard Deviation 12.37
|
2.0 bpm
Standard Deviation 13.02
|
74.3 bpm
Standard Deviation 13.49
|
2.3 bpm
Standard Deviation 11.29
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
16 hours
|
70.8 bpm
Standard Deviation 12.21
|
71.9 bpm
Standard Deviation 12.01
|
1.0 bpm
Standard Deviation 11.48
|
72.6 bpm
Standard Deviation 12.32
|
1.7 bpm
Standard Deviation 12.40
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
16.5 hours
|
69.5 bpm
Standard Deviation 10.97
|
71.0 bpm
Standard Deviation 11.59
|
1.8 bpm
Standard Deviation 12.13
|
72.0 bpm
Standard Deviation 13.19
|
2.5 bpm
Standard Deviation 12.75
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
17 hours
|
69.7 bpm
Standard Deviation 12.03
|
70.5 bpm
Standard Deviation 11.83
|
0.8 bpm
Standard Deviation 11.60
|
70.2 bpm
Standard Deviation 13.07
|
0.8 bpm
Standard Deviation 12.09
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
17.5 hours
|
69.5 bpm
Standard Deviation 10.94
|
69.9 bpm
Standard Deviation 11.53
|
0.5 bpm
Standard Deviation 12.57
|
70.3 bpm
Standard Deviation 13.13
|
0.4 bpm
Standard Deviation 13.22
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
18 hours
|
68.2 bpm
Standard Deviation 11.40
|
68.7 bpm
Standard Deviation 10.61
|
0.5 bpm
Standard Deviation 11.33
|
69.4 bpm
Standard Deviation 12.94
|
1.4 bpm
Standard Deviation 12.65
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
18.5 hours
|
68.4 bpm
Standard Deviation 11.24
|
68.4 bpm
Standard Deviation 11.23
|
0.2 bpm
Standard Deviation 10.66
|
69.5 bpm
Standard Deviation 13.10
|
1.4 bpm
Standard Deviation 13.11
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
19 hours
|
67.4 bpm
Standard Deviation 10.88
|
67.6 bpm
Standard Deviation 10.68
|
0.4 bpm
Standard Deviation 10.56
|
69.2 bpm
Standard Deviation 13.04
|
2.1 bpm
Standard Deviation 11.70
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
19.5 hours
|
67.1 bpm
Standard Deviation 11.10
|
67.4 bpm
Standard Deviation 11.15
|
0.9 bpm
Standard Deviation 11.08
|
69.8 bpm
Standard Deviation 12.70
|
2.7 bpm
Standard Deviation 12.47
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
20 hours
|
68.5 bpm
Standard Deviation 11.67
|
66.8 bpm
Standard Deviation 10.85
|
-1.2 bpm
Standard Deviation 11.74
|
67.7 bpm
Standard Deviation 12.50
|
-0.4 bpm
Standard Deviation 13.55
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
20.5 hours
|
68.5 bpm
Standard Deviation 12.28
|
67.3 bpm
Standard Deviation 11.70
|
-0.8 bpm
Standard Deviation 13.57
|
68.4 bpm
Standard Deviation 12.36
|
0.0 bpm
Standard Deviation 12.43
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
21 hours
|
69.0 bpm
Standard Deviation 11.22
|
68.1 bpm
Standard Deviation 12.46
|
-0.6 bpm
Standard Deviation 13.25
|
68.8 bpm
Standard Deviation 12.70
|
-0.2 bpm
Standard Deviation 12.68
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
22 hours
|
71.3 bpm
Standard Deviation 15.14
|
70.4 bpm
Standard Deviation 13.80
|
-0.6 bpm
Standard Deviation 16.58
|
73.0 bpm
Standard Deviation 14.46
|
3.1 bpm
Standard Deviation 14.46
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
22.5 hours
|
73.6 bpm
Standard Deviation 12.08
|
75.0 bpm
Standard Deviation 15.82
|
2.2 bpm
Standard Deviation 16.44
|
75.3 bpm
Standard Deviation 16.29
|
3.1 bpm
Standard Deviation 14.80
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
23 hours
|
75.9 bpm
Standard Deviation 16.45
|
74.5 bpm
Standard Deviation 13.07
|
1.2 bpm
Standard Deviation 12.72
|
75.9 bpm
Standard Deviation 13.58
|
1.8 bpm
Standard Deviation 12.75
|
|
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
23.5 hours
|
74.2 bpm
Standard Deviation 11.67
|
77.8 bpm
Standard Deviation 13.99
|
3.2 bpm
Standard Deviation 14.69
|
79.6 bpm
Standard Deviation 17.40
|
3.7 bpm
Standard Deviation 12.82
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Modified Extension Treatment Set
Percentage of SOV2012-F1 treated subjects with maximum NaF/EDTA plasma T levels falling into three concentration groups after 90 days of treatment with SOV2012-F1.
Outcome measures
| Measure |
SOV2012-F1-treated
n=139 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
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 enrolled in the serum sub study.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN
Plasma T Cmax <=1200 ng/dL after 90days
|
114 Participants
|
—
|
—
|
—
|
—
|
|
Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN
Plasma T Cmax <=1440 ng/dL to 2000 ng/dL after 90days
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Percentage of SOV2012-F1-Treated Subjects With Maximum Plasma Testosterone Concentration After 90 Days of Treatment: < 1.5X Upper Limit of Normal (ULN); 1.8 to ≤ 2.5X ULN; > 2.5X ULN
Plasma T Cmax >2000 ng/dL after 90days
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Modified Extension Treatment Set
Percentage of SOV2012-F1 treated subjects with maximum serum levels falling into three concentration groups after 90 days of treatment with SOV2012-F1.
Outcome measures
| Measure |
SOV2012-F1-treated
n=89 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
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 enrolled in the serum sub study.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
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
T Cmax <=1500 ng/dL After 90 Days
|
81 Participants
|
—
|
—
|
—
|
—
|
|
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
T Cmax 1800 to 2500 ng/dL After 90 Days
|
4 Participants
|
—
|
—
|
—
|
—
|
|
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
T Cmax >2500 ng/dL After 90 Days
|
0 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 180 daysPopulation: Extension Treated Set
Number of subjects of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study withdrawal in SOV2012-F1-treated subjects
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
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 enrolled in the serum sub study.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any TEAEs
|
58 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any Serious TEAEs
|
2 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any Treatment-related TEAEs
|
13 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any Treatment-related Serious TEAEs
|
0 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any Severe TEAEs
|
3 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any Treatment-related Severe TEAEs
|
0 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any TEAEs leading to Discontinuation from Study Drug
|
1 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any TEAEs leading to Death
|
0 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any MACE
|
0 Participants
|
—
|
—
|
—
|
—
|
|
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
Any TEAEs of Hypertension or Blood Pressure Increased
|
6 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 90, 119 and 179 daysPopulation: Extension Treated Set
Measured by in-clinic BP measurement of sBP, mmHg, observed and change from baseline at baseline, 90, 120 and 180 days after treatment with SOV2012-F1.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.
Baseline EXT
|
126.10 mmHg
Standard Deviation 9.800
|
0 mmHg
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.
Visit 12E - Day 90E
|
127.89 mmHg
Standard Deviation 9.961
|
2.06 mmHg
Standard Deviation 10.303
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.
Visit 13E - Day 119E
|
128.51 mmHg
Standard Deviation 10.912
|
2.70 mmHg
Standard Deviation 10.695
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.
Visit 15E - Day 179E
|
128.09 mmHg
Standard Deviation 10.012
|
2.39 mmHg
Standard Deviation 10.522
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 90, 119 and 179 daysPopulation: Extension Treated Set
Measured by in-clinic HR measurement, beats per minute during the treatment period, at baseline, and after 90, 120 and 180 days of treatment with SOV2012-F1.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.
Baseline EXT
|
71.9 beats/minute
Standard Deviation 9.48
|
0 beats/minute
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.
Visit 12E - Day 90E
|
73.9 beats/minute
Standard Deviation 9.42
|
1.9 beats/minute
Standard Deviation 9.09
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.
Visit 13E - Day 119E
|
72.9 beats/minute
Standard Deviation 9.40
|
1.1 beats/minute
Standard Deviation 9.13
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.
Visit 15E - Day 179E
|
74.3 beats/minute
Standard Deviation 10.26
|
2.6 beats/minute
Standard Deviation 9.37
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 and 180 daysPopulation: Extension Treated Set
Alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of Units per Liter (U/L)
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Alkaline Phosphatase, Baseline
|
72.5 U/L
Standard Deviation 22.90
|
0 U/L
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Alkaline Phosphatase, Visit 12E - Day 90E
|
70.4 U/L
Standard Deviation 50.29
|
-2.2 U/L
Standard Deviation 33.68
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Alkaline Phosphatase, Visit 16E - EOT Day 180E
|
65.0 U/L
Standard Deviation 18.43
|
-5.7 U/L
Standard Deviation 10.60
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Alanine Aminotransferase (ALT), Baseline
|
32.0 U/L
Standard Deviation 15.15
|
0 U/L
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Alanine Aminotransferase (ALT), Visit 12E - Day 90E
|
26.5 U/L
Standard Deviation 12.10
|
-5.1 U/L
Standard Deviation 13.37
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Alanine Aminotransferase (ALT), Visit 16E - Day 180E
|
26.9 U/L
Standard Deviation 14.18
|
-4.2 U/L
Standard Deviation 14.46
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Aspartate Aminotransferase (AST), Baseline
|
24.1 U/L
Standard Deviation 13.48
|
0 U/L
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Aspartate Aminotransferase (AST), Visit 12E - Day 90E
|
22.5 U/L
Standard Deviation 9.36
|
-1.4 U/L
Standard Deviation 14.26
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
Aspartate Aminotransferase (AST), Visit 16E - Day 180E
|
21.6 U/L
Standard Deviation 8.73
|
-1.9 U/L
Standard Deviation 13.28
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 and 180 daysPopulation: Extension Treated Set
Total bilirubin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests
Bilirubin, Baseline
|
0.441 mg/dL
Standard Deviation 0.2053
|
0 mg/dL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests
Bilirubin, Visit 12E - Day 90
|
0.361 mg/dL
Standard Deviation 0.1976
|
-0.077 mg/dL
Standard Deviation 0.1629
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests
Bilirubin, Visit 16E - EOYDay 180
|
0.431 mg/dL
Standard Deviation 0.2383
|
-0.004 mg/dL
Standard Deviation 0.1863
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 and 180 daysPopulation: Extension Treated Set
Hemoglobin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of g/dL.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period.
Hemoglobin, Baseline
|
14.72 g/dL
Standard Deviation 1.094
|
0 g/dL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period.
Hemoglobin, Visit 12E - Day 90E
|
15.13 g/dL
Standard Deviation 1.488
|
0.41 g/dL
Standard Deviation 1.082
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period.
Hemoglobin, Visit 16E - EOT Day 180E
|
15.19 g/dL
Standard Deviation 1.490
|
0.48 g/dL
Standard Deviation 1.068
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 and 180 daysPopulation: Extension Treated Set
Luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\] in SOV2012-F1 treated subjects during the treatment period, measurement units of mIU/mL.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Hormone Levels.
Luteinizing Hormone, Baseline
|
5.91 mIU/mL
Standard Deviation 4.119
|
0 mIU/mL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hormone Levels.
Luteinizing Hormone, Visit 12E - Day 90E
|
2.13 mIU/mL
Standard Deviation 2.534
|
-3.71 mIU/mL
Standard Deviation 4.410
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hormone Levels.
Luteinizing Hormone, Visit 16E - EOT Day 180E
|
2.39 mIU/mL
Standard Deviation 2.821
|
-3.37 mIU/mL
Standard Deviation 4.342
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hormone Levels.
Follicle Stimulating Hormone, Baseline
|
5.83 mIU/mL
Standard Deviation 4.890
|
0 mIU/mL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hormone Levels.
Follicle Stimulating Hormone, Visit 12E - Day 90E
|
2.47 mIU/mL
Standard Deviation 3.037
|
-3.28 mIU/mL
Standard Deviation 4.506
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hormone Levels.
Follicle Stimulating Hormone, Visit 16E - EOT Day 180E
|
2.52 mIU/mL
Standard Deviation 3.073
|
-3.19 mIU/mL
Standard Deviation 4.457
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 and 180 daysPopulation: Extension Treated Set
Sex hormone-binding globulin \[SHBG\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of nmol/L.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Hormone Levels for SHBG.
Sex Hormone Binding Globulin, Visit 16E - EOT Day 180E
|
18.97 nmol/L
Standard Deviation 11.385
|
-10.45 nmol/L
Standard Deviation 8.630
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hormone Levels for SHBG.
Sex Hormone Binding Globulin, Visit 12E - Day 90E
|
20.30 nmol/L
Standard Deviation 12.254
|
-8.53 nmol/L
Standard Deviation 7.901
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Hormone Levels for SHBG.
Sex Hormone Binding Globulin, Baseline
|
28.81 nmol/L
Standard Deviation 14.193
|
0 nmol/L
Standard Deviation 0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 and 180 daysPopulation: Extension Treated Set
Thyroid stimulating hormone \[TSH\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mU/L.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Thyrotropin
Thyrotropin, Baseline
|
3.014 mU/L
Standard Deviation 6.8492
|
0 mU/L
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Thyrotropin
Thyrotropin, Visit 12E - Day 90E
|
2.985 mU/L
Standard Deviation 3.9809
|
-0.101 mU/L
Standard Deviation 5.9459
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Thyrotropin
Thyrotropin, Visit 16E - EOT Day 180E
|
2.263 mU/L
Standard Deviation 1.2560
|
0.003 mU/L
Standard Deviation 1.0863
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 and 180 daysPopulation: Extension Treated Set
Lipid profiles (high and low-density lipoproteins, total cholesterol, triglycerides) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
Cholesterol, Baseline
|
186.4 mg/dL
Standard Deviation 38.38
|
0 mg/dL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
Cholesterol, Visit 12E - Day 90E
|
171.7 mg/dL
Standard Deviation 40.52
|
-14.5 mg/dL
Standard Deviation 31.69
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
Cholesterol, Visit 16E - EOT Day 180E
|
176.2 mg/dL
Standard Deviation 41.62
|
-11.1 mg/dL
Standard Deviation 30.50
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
HDL Cholesterol, Baseline
|
45.3 mg/dL
Standard Deviation 11.94
|
0 mg/dL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
HDL Cholesterol, Visit 12E - Day 90E
|
37.2 mg/dL
Standard Deviation 9.74
|
-7.8 mg/dL
Standard Deviation 7.75
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
HDL Cholesterol, Visit 16E - EOT Day 180E
|
38.2 mg/dL
Standard Deviation 10.37
|
-6.9 mg/dL
Standard Deviation 8.70
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
LDL Cholesterol, Baseline
|
120.8 mg/dL
Standard Deviation 35.85
|
0 mg/dL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
LDL Cholesterol, Visit 12E - Day 90E
|
113.4 mg/dL
Standard Deviation 37.52
|
-7.8 mg/dL
Standard Deviation 27.57
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
LDL Cholesterol, Visit 16E - EOT Day 180E
|
117.7 mg/dL
Standard Deviation 38.20
|
-4.0 mg/dL
Standard Deviation 29.14
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
Triglycerides, Baseline
|
179.3 mg/dL
Standard Deviation 123.60
|
0 mg/dL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
Triglycerides, Visit 12E - Day 90E
|
158.9 mg/dL
Standard Deviation 83.79
|
-16.7 mg/dL
Standard Deviation 101.61
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
Triglycerides, Visit 16E - EOT Day 180E
|
160.1 mg/dL
Standard Deviation 102.90
|
-18.6 mg/dL
Standard Deviation 106.48
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 and 180 daysPopulation: Extension Treated Set
Serum prostate-specific antigen (PSA) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of ng/mL.
Outcome measures
| Measure |
SOV2012-F1-treated
n=155 Participants
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
SERUM
n=155 Participants
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.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 120 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180E
Observed Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
SOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
Change from baseline for Ambulatory Blood Pressure Monitoring sBP after 180 days of treatment with SOV2012-F1.
|
|---|---|---|---|---|---|
|
Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period.
Prostate Specific Antigen, Visit 16E - EOT Day 180E
|
1.09 ng/mL
Standard Deviation 0.743
|
0.15 ng/mL
Standard Deviation 0.443
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period.
Prostate Specific Antigen, Baseline
|
0.98 ng/mL
Standard Deviation 0.651
|
0 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
|
Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period.
Prostate Specific Antigen, Visit 12E - Day 90E
|
1.10 ng/mL
Standard Deviation 0.719
|
0.15 ng/mL
Standard Deviation 0.309
|
—
|
—
|
—
|
Adverse Events
SOV2012-F1-treated
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOV2012-F1-treated
n=155 participants at risk
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/155 • Number of events 1 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.65%
1/155 • Number of events 1 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
Other adverse events
| Measure |
SOV2012-F1-treated
n=155 participants at risk
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.
SOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.
|
|---|---|
|
Vascular disorders
Hypertension
|
2.6%
4/155 • Number of events 4 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.2%
8/155 • Number of events 8 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.2%
5/155 • Number of events 5 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
|
Infections and infestations
Influenza
|
2.6%
4/155 • Number of events 4 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
|
Infections and infestations
Bronchitis
|
1.9%
3/155 • Number of events 3 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
|
Investigations
Hemoglobin increased
|
1.9%
3/155 • Number of events 3 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
|
Nervous system disorders
Headache
|
1.9%
3/155 • Number of events 3 • 180 days
All-Cause Mortality includes all causes; Serious Adverse events includes all causes; Other Adverse Events category includes only AE's judged by clinical investigators to have been treatment-related.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place