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CompletedNCT04467697Updated Jun 28, 2024Results posted

Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men

A Phase 3 interventional study of SOV2012-F1 in Hypogonadism, Male, sponsored by Marius Pharmaceuticals. Completed at 19 sites in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-28.

Sponsored by Marius Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
155
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

The purpose of this six-month treatment study is

  • to assess feasibility of a lower starting dose of SOV2012-F1 (daily dose of 400 mg [200 mg with breakfast meal and 200mg with dinner meal]) to titrate individual doses to further enhance efficacy and safety.
  • To examine the blood pressure (BP) effects of Marius's oral testosterone undecanoate formulation, SOV2012-F1, using 24-hour ambulatory blood pressure monitoring (ABPM).
Read the detailed description

This is the six-month treatment extension of Study MRS-TU-2019, which like Study MRS-TU-2019 (NCT03198728), is an open-label study. The MRS-TU-2019 ABPM Extension Study (MRS-TU-2019EXT; NCT04467697), will extend the participation for up to 170 MRS-TU-2019 subjects and to new subjects, for a target of 135 evaluable subjects reaching the 4-month ABPM assessment. All subjects were washed out from previous testosterone therapy if they were not naïve. The study used ABPM monitoring to assess baseline and change from baseline after 120 and 180 days of treatment. The percentage of participants within the normal range for testosterone was assessed after two titration cycles and a total of 90 days of treatment.

02

Conditions studied

  • Hypogonadism, Male
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

For all subjects participating in MRS-TU-2019EXT, whether rolling over from MRS-TU-2019 (after washout) or newly enrolling, the following MRS-TU-2019EXT Inclusion/Exclusion Criteria apply:

Inclusion criteria

Inclusion Criteria:

  1. Completion of MRS-TU-2019 Day 365/ End of Treatment

Exclusion criteria

Exclusion Criteria:

  1. Upper arm circumference > 45 cm.
  2. Long distance driving or planned driving trip (> 60 mins duration where the subject is doing the driving) during period of wearing ABPM cuff.
  3. Expected / known forthcoming change to antihypertensive medication(s) during the MRS-TU-2019 EXT extension study.
  4. Cardiac arrhythmias that, in the opinion of the investigator, interfere with the ability of the ABPM recorder to obtain reliable measurements.
  5. Use of T implantable pellets since completion of Day 365/EOT visit in MRS-TU- 2019.

For newly enrolling subjects into MRS-TU-2019EXT (naïve to MRS-TU-2019), the applicable Inclusion/Exclusion criteria from the MRS-TU-2019 study, also must be met :

MRS-TU-2019 Key Inclusion Criteria:

  1. Male aged 18 to 65 years, inclusive, at the time of providing informed consent to participate in the study.
  2. Hypogonadism defined as having 2 consecutive serum total T levels ≤ 281 ng/dL based on a blood sample, drawn at least 3 days apart, between 7 a.m. and 10 a.m.
  3. At least 1 clinical feature consistent with male hypogonadism. If a subject is receiving commercial TRT prior to Screening Visit 1, he must have a history of at least 1 clinical feature consistent with male hypogonadism.
  4. Must be naïve to androgen replacement therapy or washed out adequately of prior androgen replacement therapies; willing to cease current T treatment; or currently not taking any T treatment. Subjects must remain off all forms of T, except for dispensed study drug, throughout the entire study.

  5. No unstable ongoing concomitant medical conditions. Treated and well-controlled conditions such as type 2 diabetes, hypertension, or dyslipidemia are acceptable with stable medication in place for at least 3 months prior to study entry:

    1. Hemoglobin A1c \< 8.0%

    2. BP \< 150/90 mm Hg

      • *for MRS-TU-2019EXT ABPM Extension Study, the in-clinic, average BP must be \< 140/90 for inclusion into the MRS-TU-2019EXT study.
    3. Low-density lipoprotein cholesterol \< 190 mg/dL.
  6. Subjects with an endocrine disorder requiring treatment other than hypogonadism must be on a stable dose of replacement medication for at least 3 months prior to study entry.
  7. Adequate venous access to allow collection of a number of blood samples via a venous cannula.
  8. Written informed consent to participate in the study and ability to comply with all study requirements.

MRS-TU-2019 Key Exclusion Criteria:

  1. Serum PSA > 2.5 ng/ml and/or abnormal prostate gland on palpation, e.g., palpable nodes, at Screening Visit 2.

  2. Received oral, topical, intranasal, or buccal T therapy within the previous 2 weeks, intramuscular T injection of short-acting duration within the previous 4 weeks, intramuscular T injection of long-acting duration within the previous 20 weeks, or T implantable pellets within the previous 6 months.

    *For ABPM Extension Study Only: Newly Enrolled Subjects to MRS-TU-2019EXT ABPM Extension Study, patients must not have received prior testosterone replacement therapy within 8 weeks of the start of the study, with the exception of T implantable pellets which are excluded for 6 months.

  3. Use of any drug that could interfere with measurement or assessment of serum androgen levels, including 5 alpha-reductase inhibitors, anabolic steroids, and drugs with antiandrogenic properties (e.g., spironolactone, cimetidine, flutamide, bicalutamide, and ketoconazole). These drugs must be stopped for at least 1 month prior to study entry (6 months in the case of dutasteride). Patients taking potent, long- acting opiate therapy on a daily basis are not eligible for the study. Conversely, ad hoc use of potent, short-acting opiates for a period of less than 7 days may be permitted after discussion with the Marius Pharmaceuticals medical monitor.
  4. Use of over-the-counter products, including natural health products (e.g., food supplements and herbal supplements such as saw palmetto or phytoestrogens) that may affect total T levels, within 7 days prior to study entry.
  5. History of drug or alcohol abuse within the past 2 years that in the opinion of the investigator could interfere with study participation and/or influence study efficacy and safety endpoints assessments.
  6. Unstable or chronic disease that could interfere with participation in the study or patient safety, including psychiatric disorders.
  7. Myocardial infarction, coronary artery surgery, heart failure, stroke, unstable angina, or other unstable cardiovascular disease within the past 6 months.
  8. Abnormal ECG considered clinically significant by investigator at Screening.
  9. Diagnosis of any cancer within the previous 5 years other than basal or squamous cell skin cancer with clear margins.
  10. Any surgical or medical condition that might alter administration of the study drug or comparator, including history of gastric surgery, cholecystectomy, vagotomy, small bowel resection, or any surgical procedure or medications (e.g., GLP-1 agonists and motility agents such as domperidone, metoclopramide, etc.) that might interfere with gastrointestinal motility, pH, or absorption of TU.
  11. Duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to screening.
  12. Chronic skin conditions on the chest or upper arms that would prevent administration of AndroGel in a manner designed to ensure reliable and consistent absorption thereof
  13. Human immunodeficiency virus (HIV) infection.
  14. Chronic hepatitis B virus and/or hepatitis C virus (HCV) infection (as determined by positive testing for hepatitis B virus surface antigen or HCV antibody with confirmatory testing, i.e., detectable serum HCV ribonucleic acid [RNA])

  15. Clinically significant abnormal laboratory values at screening including but not limited to:

    1. Elevated liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT] > 2X upper limit of normal)
    2. Estimated glomerular filtration rate \< 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease formula
    3. Hemoglobin \< 11.0 g/dL or > 16.0 g/dL. For a subject previously on testosterone replacement therapy with less than 30 days washout prior to screening Visit 2, hemoglobin \< 11.0 g/dL or > 17.0 g/dL.
  16. Severe or untreated obstructive sleep apnea syndrome.
  17. Severe lower urinary tract symptoms (American Urological Association/ IPSS ≥ 19).
  18. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study entry.
  19. Past, current, or suspected prostate or breast cancer.
  20. History of long QT syndrome or unexplained sudden death in a first-degree relative (parent, sibling, or child).
  21. Concurrent treatment with medications that may impact the absorption, distribution, metabolism, or excretion of TU or place the subject at risk for treatment with T.
  22. Subject has a partner who is currently pregnant or planning pregnancy during the course of the study.
  23. Treatment with any other investigational drug within 30 days of study entry or > 5 half- lives (whichever is longer) and at any time during the study.
  24. History of noncompliance to medical regimens or potential unreliability in the opinion of the investigator.
  25. Unwilling or unable to comply to the dietary requirements for this study.
  26. History of polycythemia, either idiopathic or associated with TRT.
  27. Donated blood (≥ 500 mL) within the 12-week period prior to study entry.
  28. History of an abnormal bleeding tendency or thrombophlebitis within the previous 2 years that is not linked to venipuncture or intravenous cannulation.
  29. Onset of gynecomastia within the previous 6 months.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    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 and 400 mg in the evening) or titrated down to a minimum of 100 mg SOV2012-F1 per day (100 mg in the morning) based on plasma T after 14 and 42 days of treatment, intermediate dose levels include total daily doses of 600 mg, 400 mg and 200 mg.

    Drug: SOV2012-F1

Interventions

  • DrugSOV2012-F1

    Oral preparation of testosterone undecanoate (TU). Strengths of 100 mg TU, 150 mg TU and 200 mg TU

05

What researchers measure

Primary outcomes

  1. Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment

    Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis).

    Time frame: 120 days

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

    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.

    Time frame: 90 days

Secondary outcomes

  1. Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.

    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).

    Time frame: 120 and 180 days

  2. Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.

    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).

    Time frame: 120 and 180 days

  3. Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.

    Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis.

    Time frame: 120 and 180 days

  4. Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.

    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.

    Time frame: 120 and 180 days

  5. Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.

    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.

    Time frame: 120 and 180 days

  6. Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.

    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.

    Time frame: 120 and 180 days

  7. 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

    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.

    Time frame: 90 days

  8. 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

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

    Time frame: 90 days

Other outcomes

  1. AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.

    Number of subjects of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study withdrawal in SOV2012-F1-treated subjects

    Time frame: 180 days

  2. Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.

    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.

    Time frame: Baseline, 90, 119 and 179 days

  3. Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.

    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.

    Time frame: Baseline, 90, 119 and 179 days

  4. Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase

    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)

    Time frame: 90 and 180 days

  5. Observed and Change From Baseline in Hematology Parameters in Liver Function Tests

    Total bilirubin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL

    Time frame: 90 and 180 days

  6. Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period.

    Hemoglobin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of g/dL.

    Time frame: 90 and 180 days

  7. Observed and Change From Baseline in Hormone Levels.

    Luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\] in SOV2012-F1 treated subjects during the treatment period, measurement units of mIU/mL.

    Time frame: 90 and 180 days

  8. Observed and Change From Baseline in Hormone Levels for SHBG.

    Sex hormone-binding globulin \[SHBG\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of nmol/L.

    Time frame: 90 and 180 days

  9. Observed and Change From Baseline in Thyrotropin

    Thyroid stimulating hormone \[TSH\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mU/L.

    Time frame: 90 and 180 days

  10. Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.

    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.

    Time frame: 90 and 180 days

  11. Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period.

    Serum prostate-specific antigen (PSA) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of ng/mL.

    Time frame: 90 and 180 days

06

Results

Posted Jun 28, 2024

Participant flow

Participant flow — Overall Study
MilestoneSOV2012-F1-treated
Started155
Completed135
Not completed20
Withdrew: Adverse event2
Withdrew: Lost to follow-up6
Withdrew: Withdrawal by subject9
Withdrew: Protocol violation3

Outcome measures

PrimaryChange From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment

Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis).

Time frame:
120 days
Reported as:
Least squares mean · mmHg
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment
mmHgSOV2012-F1-treated
Baseline128.9 (126.8 to 131.0)
Observed Visit 14E - Day 120E130.6 (128.5 to 132.7)
Change from baseline (Visit 14E - Day 120E)1.7 (0.3 to 3.1)
PrimaryPlasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration

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.

Time frame:
90 days
Reported as:
Number · percentage of participants
Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration
percentage of participantsNaF/EDTA PLASMASERUM
Worst case scenario87.8 (82.3 to 93.2)86.5 (79.4 to 93.6)
Day 90 completers96.1 (92.7 to 99.4)87.5 (80.6 to 94.4)
SecondaryChange From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.

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).

Time frame:
120 and 180 days
Reported as:
Least squares mean · mmHg
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
mmHgSOV2012-F1-treated
Baseline128.9 (126.8 to 131.0)
Observed Visit 14E (Day 120E)130.6 (128.5 to 132.7)
Change from baseline (Day 120E - Day 1E)1.7 (0.3 to 3.1)
Observed Visit 16E (Day 180E)130.7 (128.6 to 132.8)
Change from baseline (Day 180E - Day 1E)1.8 (0.3 to 3.2)
SecondaryChange From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.

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).

Time frame:
120 and 180 days
Reported as:
Least squares mean · mmHg
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
mmHgSOV2012-F1-treated
Baseline76.2 (74.6 to 77.9)
Observed Visit 14E (Day 120E)76.9 (75.3 to 78.5)
Change from Baseline to Visit 14E (Day 120E)0.6 (-0.3 to 1.6)
Observed Visit 16E (Day 180E)76.9 (75.2 to 78.5)
Change from Baseline to Visit 16E (Day 180E)0.6 (-0.4 to 1.6)
SecondaryChange From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.

Ambulatory Blood Pressure Monitoring (ABPM) at 120 Days (+/-3) and after 180 Days (+/- 3) of SOV2012-F1 Treatment (Mixed Model Repeated Measures analysis.

Time frame:
120 and 180 days
Reported as:
Least squares mean · bpm
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
bpmSOV2012-F1-treated
Baseline76.3 (74.4 to 78.3)
Observed Visit 14E (Day 120E)77.0 (75.1 to 79.0)
Change from baseline to Visit 14E (Day 120E)0.7 (-0.5 to 1.9)
Observed Visit 16E (Day 180E)78.2 (76.2 to 80.2)
Change from baseline to Visit 16E (Day 180E)1.9 (0.6 to 3.1)
SecondaryObserved and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.

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.

Time frame:
120 and 180 days
Reported as:
Mean · mmHg
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
mmHgSOV2012-F1-treated - Systolic Blood Pressure (sBP), BaselineSOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 14E - Day 120ESOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 14E - Day 120ESOV2012-F1-treated - Systolic Blood Pressure (sBP), Visit 16E - Day 180ESOV2012-F1-treated - Systolic Blood Pressure (sBP), Change From Baseline, Visit 16E - Day 180E
0 hours133.3 ± 12.02133.7 ± 12.900.7 ± 13.90133.1 ± 11.95-0.0 ± 13.17
0.5 hours135.6 ± 15.23134.2 ± 13.87-0.6 ± 13.70133.1 ± 12.22-2.2 ± 15.53
1 hour133.9 ± 15.28133.9 ± 13.530.4 ± 15.54135.5 ± 13.071.7 ± 16.52
1.5 hours132.3 ± 15.32132.8 ± 13.760.9 ± 14.80133.5 ± 13.751.6 ± 16.49
2 hours131.9 ± 15.60132.7 ± 14.171.9 ± 16.23132.6 ± 15.871.7 ± 18.07
2.5 hours130.9 ± 15.29132.6 ± 15.861.8 ± 16.23132.5 ± 14.082.4 ± 16.15
3 hours130.9 ± 15.84131.2 ± 15.861.0 ± 18.59132.2 ± 14.621.9 ± 19.28
3.5 hours130.6 ± 15.54131.5 ± 16.281.0 ± 18.33131.5 ± 16.532.0 ± 17.44
4 hours130.7 ± 14.42133.2 ± 15.352.2 ± 14.82131.9 ± 15.722.3 ± 14.91
4.5 hours130.5 ± 15.73131.5 ± 15.781.0 ± 15.69132.4 ± 14.702.6 ± 15.20
5 hours129.3 ± 15.69133.5 ± 16.694.8 ± 17.57130.8 ± 15.982.2 ± 16.13
5.5 hours130.8 ± 16.20133.8 ± 16.343.4 ± 18.06132.4 ± 16.832.5 ± 17.31
6 hours130.9 ± 16.68133.2 ± 14.863.2 ± 16.16132.2 ± 16.082.5 ± 17.79
6.5 hours131.2 ± 17.44132.4 ± 15.722.1 ± 19.08131.4 ± 16.311.6 ± 19.24
7 hours131.8 ± 16.52133.0 ± 16.161.3 ± 17.51129.7 ± 15.41-0.9 ± 16.11
7.5 hours131.5 ± 17.07133.3 ± 15.531.6 ± 17.44132.2 ± 13.531.2 ± 17.22
8 hours132.6 ± 15.63132.3 ± 13.22-0.8 ± 16.38131.9 ± 13.98-0.2 ± 15.65
8.5 hours133.6 ± 15.24133.7 ± 14.740.7 ± 16.51131.2 ± 13.51-1.4 ± 14.26
9 hours133.7 ± 15.37134.0 ± 15.990.6 ± 16.46131.4 ± 14.44-1.4 ± 16.61
9.5 hours133.0 ± 16.47134.7 ± 15.241.5 ± 17.82131.8 ± 15.67-0.4 ± 15.64
10 hours132.5 ± 16.52133.6 ± 15.091.4 ± 17.78134.2 ± 15.351.6 ± 18.16
10.5 hours133.3 ± 16.54134.9 ± 17.511.5 ± 18.15133.0 ± 13.51-0.3 ± 16.86
11 hours132.1 ± 15.55134.9 ± 15.432.6 ± 16.27132.0 ± 13.450.7 ± 16.09
11.5 hours131.4 ± 15.99133.5 ± 14.611.9 ± 16.23132.7 ± 14.421.7 ± 15.13
12 hours129.8 ± 15.25132.6 ± 15.452.7 ± 16.85131.7 ± 14.922.7 ± 18.01
12.5 hours129.5 ± 15.29131.4 ± 15.812.4 ± 18.09131.7 ± 14.193.4 ± 16.25
13 hours126.9 ± 16.11131.4 ± 16.175.3 ± 17.42130.9 ± 16.125.3 ± 18.77
13.5 hours126.7 ± 15.55130.1 ± 17.213.3 ± 18.80131.0 ± 16.294.6 ± 18.61
14 hours125.1 ± 16.69127.8 ± 15.682.9 ± 18.06128.0 ± 16.682.8 ± 20.12
14.5 hours123.7 ± 16.27127.2 ± 16.383.2 ± 17.49126.7 ± 16.223.4 ± 19.46
15 hours122.4 ± 15.78125.7 ± 16.483.5 ± 18.12127.1 ± 17.744.3 ± 16.45
15.5 hours121.1 ± 16.98124.2 ± 16.923.1 ± 18.83125.4 ± 18.383.6 ± 20.19
16 hours119.2 ± 16.09122.0 ± 15.242.3 ± 17.88123.4 ± 14.403.8 ± 15.77
16.5 hours116.8 ± 16.02120.5 ± 16.583.9 ± 16.94121.4 ± 14.994.5 ± 17.09
17 hours116.9 ± 15.07118.4 ± 16.391.0 ± 17.28120.7 ± 16.513.3 ± 17.81
17.5 hours117.4 ± 15.03118.4 ± 16.000.5 ± 16.84119.8 ± 16.352.1 ± 15.50
18 hours116.4 ± 15.44118.0 ± 16.121.3 ± 17.87118.6 ± 15.262.6 ± 17.10
18.5 hours117.7 ± 15.18117.4 ± 16.310.1 ± 16.51118.5 ± 15.022.3 ± 15.92
19 hours116.1 ± 14.22117.2 ± 15.371.1 ± 16.02118.1 ± 16.611.9 ± 16.23
19.5 hours116.5 ± 15.54118.5 ± 15.242.4 ± 16.40117.9 ± 16.192.0 ± 16.59
20 hours117.4 ± 16.25117.7 ± 16.480.6 ± 16.77119.0 ± 15.331.1 ± 14.78
20.5 hours118.2 ± 16.81117.9 ± 16.290.4 ± 18.78120.2 ± 17.501.9 ± 16.49
21 hours118.4 ± 15.85120.7 ± 16.361.7 ± 19.28121.2 ± 16.422.0 ± 17.72
21.5 hours123.0 ± 15.13121.8 ± 16.57-1.1 ± 17.92124.7 ± 16.861.9 ± 17.95
22 hours123.8 ± 16.88124.1 ± 15.370.9 ± 18.73126.0 ± 15.123.2 ± 17.04
22.5 hours127.1 ± 17.61129.5 ± 15.393.3 ± 17.35128.3 ± 16.564.6 ± 16.98
23 hours129.1 ± 16.44129.4 ± 15.250.4 ± 17.41132.6 ± 15.734.8 ± 16.49
23.5 hours131.0 ± 13.83130.4 ± 13.41-0.9 ± 13.66131.6 ± 14.620.9 ± 15.08
SecondaryObserved and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.

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.

Time frame:
120 and 180 days
Reported as:
Mean · mmHg
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
mmHgSOV2012-F1-treated - Diastolic Blood Pressure (dBP), BaselineSOV2012-F1-treated - Diastolic Blood Pressure (dBP), Visit 14E - Day 120ESOV2012-F1-treated - Diastolic Blood Pressure (dBP), Change From Baseline, Visit 14E - Day 120ESOV2012-F1-treated - Diastolic Blood Pressure (dBP), Visit 16E - Day 180ESOV2012-F1-treated - Diastolic Blood Pressure (dBP), Change From Baseline, Visit 16E - Day 180E
0 hours83.7 ± 9.7883.9 ± 10.090.6 ± 9.9083.3 ± 9.160.1 ± 9.51
0.5 hours83.5 ± 11.7182.2 ± 10.36-1.0 ± 11.3582.9 ± 10.30-0.2 ± 11.42
1 hour81.7 ± 11.4282.0 ± 11.100.3 ± 12.6982.9 ± 11.191.4 ± 12.38
1.5 hours80.9 ± 12.3780.8 ± 10.800.6 ± 10.8181.1 ± 10.971.2 ± 12.32
2 hours81.2 ± 11.6680.4 ± 12.830.4 ± 12.9179.8 ± 10.62-0.0 ± 12.29
2.5 hours79.0 ± 11.5479.4 ± 12.280.7 ± 15.3680.2 ± 11.051.6 ± 13.62
3 hours78.9 ± 12.1379.0 ± 12.82-0.1 ± 14.3479.5 ± 11.600.5 ± 14.85
3.5 hours79.8 ± 12.5679.9 ± 12.25-0.2 ± 14.1779.1 ± 11.75-0.2 ± 12.58
4 hours79.1 ± 11.3680.7 ± 11.871.2 ± 12.1979.2 ± 11.170.5 ± 10.83
4.5 hours79.6 ± 12.5579.3 ± 12.48-0.5 ± 12.8479.3 ± 10.530.2 ± 12.21
5 hours78.1 ± 13.5179.9 ± 12.152.2 ± 13.7478.3 ± 12.220.9 ± 12.21
5.5 hours77.8 ± 12.3980.9 ± 14.403.3 ± 14.0578.9 ± 12.411.5 ± 13.31
6 hours79.5 ± 12.9479.5 ± 12.270.1 ± 12.2278.3 ± 11.47-0.5 ± 13.33
6.5 hours78.5 ± 12.8978.8 ± 11.510.3 ± 13.1879.1 ± 12.721.3 ± 14.39
7 hours78.5 ± 12.9678.9 ± 11.75-0.0 ± 11.9477.9 ± 11.920.3 ± 12.75
7.5 hours79.5 ± 13.4879.5 ± 12.690.4 ± 14.0879.2 ± 11.82-0.0 ± 12.66
8 hours80.3 ± 12.7379.2 ± 11.24-1.5 ± 13.6378.9 ± 11.10-0.7 ± 12.71
8.5 hours80.1 ± 12.2280.3 ± 11.820.8 ± 12.8078.9 ± 10.52-0.6 ± 12.20
9 hours81.0 ± 12.6480.6 ± 12.260.2 ± 12.7779.1 ± 11.75-1.6 ± 13.58
9.5 hours80.3 ± 13.1180.4 ± 12.240.1 ± 13.4679.8 ± 11.990.4 ± 14.33
10 hours81.1 ± 12.6180.5 ± 11.79-0.6 ± 12.7580.4 ± 12.45-0.5 ± 13.58
10.5 hours80.4 ± 12.4879.9 ± 12.02-0.3 ± 13.5979.8 ± 11.75-0.5 ± 12.65
11 hours79.2 ± 11.7180.0 ± 12.010.6 ± 12.6079.1 ± 12.600.2 ± 13.38
11.5 hours79.1 ± 12.4879.3 ± 11.81-0.4 ± 12.4477.7 ± 12.77-0.8 ± 12.62
12 hours77.6 ± 12.7579.8 ± 11.251.9 ± 12.6077.7 ± 12.120.1 ± 14.20
12.5 hours78.3 ± 13.3778.4 ± 11.900.2 ± 13.9677.5 ± 11.80-0.3 ± 13.59
13 hours75.1 ± 12.7176.9 ± 12.522.4 ± 12.3776.3 ± 12.202.3 ± 13.55
13.5 hours75.0 ± 12.2376.7 ± 13.261.9 ± 14.8976.2 ± 11.721.5 ± 14.28
14 hours73.1 ± 12.9374.4 ± 11.731.4 ± 14.1374.0 ± 12.410.6 ± 15.89
14.5 hours72.3 ± 12.9774.2 ± 12.821.6 ± 14.5673.0 ± 11.841.1 ± 14.22
15 hours70.7 ± 12.3972.5 ± 12.362.1 ± 14.2074.3 ± 12.433.8 ± 13.00
15.5 hours69.8 ± 13.5371.8 ± 12.221.6 ± 16.1272.5 ± 13.172.3 ± 15.89
16 hours68.3 ± 13.0670.5 ± 12.461.5 ± 15.7771.0 ± 11.591.9 ± 13.87
16.5 hours67.7 ± 12.7169.8 ± 11.202.1 ± 13.0369.9 ± 12.662.4 ± 15.69
17 hours67.2 ± 11.7769.1 ± 12.041.8 ± 13.2769.6 ± 12.382.6 ± 14.27
17.5 hours67.6 ± 11.9169.3 ± 12.421.2 ± 14.7069.0 ± 12.620.8 ± 13.16
18 hours67.7 ± 12.6368.9 ± 11.620.9 ± 13.7968.0 ± 12.200.5 ± 14.84
18.5 hours68.3 ± 11.8268.6 ± 11.460.2 ± 13.7768.4 ± 12.080.7 ± 12.81
19 hours67.6 ± 11.7868.3 ± 11.140.7 ± 12.9769.2 ± 12.481.2 ± 12.54
19.5 hours67.9 ± 11.6269.4 ± 12.851.5 ± 13.4168.9 ± 13.121.2 ± 12.89
20 hours69.6 ± 12.4368.5 ± 12.95-1.3 ± 13.9369.8 ± 12.88-0.4 ± 13.50
20.5 hours69.8 ± 13.0468.9 ± 12.56-0.8 ± 14.4269.9 ± 13.25-0.2 ± 13.22
21 hours70.3 ± 13.0470.8 ± 13.560.1 ± 15.2372.8 ± 13.051.9 ± 14.26
21.5 hours73.8 ± 13.0072.6 ± 14.23-1.4 ± 15.1674.8 ± 13.791.0 ± 15.12
22 hours74.9 ± 13.3874.3 ± 13.15-0.0 ± 15.6376.2 ± 12.442.4 ± 13.20
22.5 hours77.8 ± 13.3980.4 ± 13.333.6 ± 14.7477.5 ± 12.742.3 ± 11.92
23 hours80.6 ± 12.5379.3 ± 13.72-0.8 ± 13.5281.6 ± 12.131.7 ± 12.87
23.5 hours81.8 ± 11.0582.1 ± 12.170.3 ± 12.8280.6 ± 10.98-0.3 ± 11.30
SecondaryObserved and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.

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.

Time frame:
120 and 180 days
Reported as:
Mean · bpm
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
bpmSOV2012-F1-treated - Heart Rate (Bpm), BaselineSOV2012-F1-treated - Heart Rate (Bpm), Visit 14E - Day 120ESOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 14E - Day 120ESOV2012-F1-treated - Heart Rate (Bpm), Visit 16E - Day 180ESOV2012-F1-treated - Heart Rate (Bpm), Change From Baseline, Visit 16E - Day 180E
0 hours72.6 ± 10.2274.5 ± 10.152.3 ± 9.7274.5 ± 11.633.0 ± 10.17
0.5 hours76.0 ± 12.9477.6 ± 12.700.5 ± 11.0678.1 ± 14.863.4 ± 14.24
1 hour77.7 ± 15.7780.4 ± 13.032.4 ± 16.1181.1 ± 16.174.5 ± 18.28
1.5 hours79.9 ± 12.9380.8 ± 16.361.4 ± 16.7783.1 ± 14.843.6 ± 15.81
2 hours80.7 ± 15.7980.8 ± 13.530.8 ± 16.5982.9 ± 15.783.6 ± 16.50
2.5 hours79.4 ± 14.6380.3 ± 14.600.7 ± 15.9482.8 ± 15.844.4 ± 15.38
3 hours79.0 ± 13.0879.5 ± 13.150.2 ± 14.0880.3 ± 15.852.7 ± 14.96
3.5 hours79.3 ± 15.2980.1 ± 13.810.4 ± 18.5079.9 ± 16.202.3 ± 18.42
4 hours78.4 ± 14.7379.7 ± 14.591.1 ± 15.3780.1 ± 16.232.8 ± 18.74
4.5 hours79.1 ± 15.1879.2 ± 13.650.4 ± 16.2979.9 ± 15.053.0 ± 16.75
5 hours79.0 ± 15.4280.5 ± 14.791.2 ± 16.0979.7 ± 15.392.9 ± 14.93
5.5 hours78.5 ± 14.5680.6 ± 13.191.9 ± 15.3681.0 ± 16.054.0 ± 16.48
6 hours79.3 ± 14.4180.5 ± 13.261.2 ± 15.4680.4 ± 14.022.9 ± 15.49
6.5 hours79.2 ± 15.0380.1 ± 14.401.5 ± 14.9080.4 ± 13.943.2 ± 15.91
7 hours80.6 ± 15.0480.9 ± 13.850.8 ± 14.8379.8 ± 13.270.6 ± 15.44
7.5 hours80.0 ± 14.5179.5 ± 13.66-0.3 ± 15.2081.1 ± 14.522.4 ± 14.98
8 hours81.5 ± 14.6380.8 ± 14.18-0.9 ± 15.8680.8 ± 14.340.5 ± 15.15
8.5 hours80.0 ± 14.0979.9 ± 14.41-0.1 ± 13.8979.9 ± 13.340.6 ± 14.18
9 hours80.1 ± 13.8680.9 ± 14.060.2 ± 14.7082.2 ± 13.932.5 ± 15.45
9.5 hours79.9 ± 14.2180.1 ± 16.09-0.1 ± 14.1881.8 ± 13.702.1 ± 16.58
10 hours81.8 ± 16.2880.6 ± 15.75-1.0 ± 15.2882.1 ± 14.951.1 ± 16.53
10.5 hours80.4 ± 14.7578.4 ± 13.73-2.2 ± 13.5980.7 ± 13.821.2 ± 15.30
11 hours79.9 ± 14.0780.5 ± 15.790.3 ± 14.5280.8 ± 13.142.0 ± 13.84
11.5 hours79.8 ± 14.3179.4 ± 14.58-1.0 ± 16.2680.2 ± 15.050.9 ± 14.64
12 hours79.5 ± 13.8079.3 ± 15.02-0.5 ± 15.7779.8 ± 14.571.2 ± 13.92
12.5 hours78.8 ± 13.6679.1 ± 15.120.7 ± 15.8178.9 ± 14.330.8 ± 13.62
13 hours76.4 ± 12.0477.6 ± 13.231.7 ± 13.5977.8 ± 14.492.3 ± 14.37
13.5 hours75.8 ± 12.0577.6 ± 13.902.3 ± 14.0178.1 ± 15.153.7 ± 14.77
14 hours75.6 ± 12.4775.5 ± 13.440.1 ± 13.9375.9 ± 13.631.0 ± 13.19
14.5 hours73.3 ± 12.7475.5 ± 12.802.0 ± 13.7075.1 ± 13.762.3 ± 14.03
15 hours72.5 ± 11.4774.5 ± 12.372.0 ± 13.0274.3 ± 13.492.3 ± 11.29
15.5 hours72.0 ± 12.0673.3 ± 12.411.1 ± 12.6172.9 ± 12.711.1 ± 12.61
16 hours70.8 ± 12.2171.9 ± 12.011.0 ± 11.4872.6 ± 12.321.7 ± 12.40
16.5 hours69.5 ± 10.9771.0 ± 11.591.8 ± 12.1372.0 ± 13.192.5 ± 12.75
17 hours69.7 ± 12.0370.5 ± 11.830.8 ± 11.6070.2 ± 13.070.8 ± 12.09
17.5 hours69.5 ± 10.9469.9 ± 11.530.5 ± 12.5770.3 ± 13.130.4 ± 13.22
18 hours68.2 ± 11.4068.7 ± 10.610.5 ± 11.3369.4 ± 12.941.4 ± 12.65
18.5 hours68.4 ± 11.2468.4 ± 11.230.2 ± 10.6669.5 ± 13.101.4 ± 13.11
19 hours67.4 ± 10.8867.6 ± 10.680.4 ± 10.5669.2 ± 13.042.1 ± 11.70
19.5 hours67.1 ± 11.1067.4 ± 11.150.9 ± 11.0869.8 ± 12.702.7 ± 12.47
20 hours68.5 ± 11.6766.8 ± 10.85-1.2 ± 11.7467.7 ± 12.50-0.4 ± 13.55
20.5 hours68.5 ± 12.2867.3 ± 11.70-0.8 ± 13.5768.4 ± 12.360.0 ± 12.43
21 hours69.0 ± 11.2268.1 ± 12.46-0.6 ± 13.2568.8 ± 12.70-0.2 ± 12.68
21.5 hours69.9 ± 13.5768.2 ± 11.52-1.4 ± 14.2671.6 ± 13.751.4 ± 13.83
22 hours71.3 ± 15.1470.4 ± 13.80-0.6 ± 16.5873.0 ± 14.463.1 ± 14.46
22.5 hours73.6 ± 12.0875.0 ± 15.822.2 ± 16.4475.3 ± 16.293.1 ± 14.80
23 hours75.9 ± 16.4574.5 ± 13.071.2 ± 12.7275.9 ± 13.581.8 ± 12.75
23.5 hours74.2 ± 11.6777.8 ± 13.993.2 ± 14.6979.6 ± 17.403.7 ± 12.82
SecondaryPercentage 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

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.

Time frame:
90 days
Reported as:
Count of participants · 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
ParticipantsNaF/EDTA PLASMA
Plasma T Cmax <=1200 ng/dL after 90days114
Plasma T Cmax <=1440 ng/dL to 2000 ng/dL after 90days5
Plasma T Cmax >2000 ng/dL after 90days0
SecondaryPercentage 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

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

Time frame:
90 days
Reported as:
Count of participants · 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
ParticipantsSERUM
T Cmax <=1500 ng/dL After 90 Days81
T Cmax 1800 to 2500 ng/dL After 90 Days4
T Cmax >2500 ng/dL After 90 Days0
Other pre-specifiedAEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.

Number of subjects of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study withdrawal in SOV2012-F1-treated subjects

Time frame:
180 days
Reported as:
Count of participants · Participants
AEs, SAEs and AEs Leading to MRS-TU-2019EXT Study Withdrawal of SOV2012-F1 Treated Subjects.
ParticipantsSOV2012-F1-treated
Any TEAEs58
Any Serious TEAEs2
Any Treatment-related TEAEs13
Any Treatment-related Serious TEAEs0
Any Severe TEAEs3
Any Treatment-related Severe TEAEs0
Any TEAEs leading to Discontinuation from Study Drug1
Any TEAEs leading to Death0
Any MACE0
Any TEAEs of Hypertension or Blood Pressure Increased6
Other pre-specifiedObserved and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.

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.

Time frame:
Baseline, 90, 119 and 179 days
Reported as:
Mean · mmHg
Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.
mmHgSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Baseline EXT126.10 ± 9.8000 ± 0
Visit 12E - Day 90E127.89 ± 9.9612.06 ± 10.303
Visit 13E - Day 119E128.51 ± 10.9122.70 ± 10.695
Visit 15E - Day 179E128.09 ± 10.0122.39 ± 10.522
Other pre-specifiedObserved and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.

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.

Time frame:
Baseline, 90, 119 and 179 days
Reported as:
Mean · beats/minute
Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.
beats/minuteSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Baseline EXT71.9 ± 9.480 ± 0
Visit 12E - Day 90E73.9 ± 9.421.9 ± 9.09
Visit 13E - Day 119E72.9 ± 9.401.1 ± 9.13
Visit 15E - Day 179E74.3 ± 10.262.6 ± 9.37
Other pre-specifiedObserved and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase

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)

Time frame:
90 and 180 days
Reported as:
Mean · U/L
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests of ALT, AST and Alkaline Phosphatase
U/LSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Alkaline Phosphatase, Baseline72.5 ± 22.900 ± 0
Alkaline Phosphatase, Visit 12E - Day 90E70.4 ± 50.29-2.2 ± 33.68
Alkaline Phosphatase, Visit 16E - EOT Day 180E65.0 ± 18.43-5.7 ± 10.60
Alanine Aminotransferase (ALT), Baseline32.0 ± 15.150 ± 0
Alanine Aminotransferase (ALT), Visit 12E - Day 90E26.5 ± 12.10-5.1 ± 13.37
Alanine Aminotransferase (ALT), Visit 16E - Day 180E26.9 ± 14.18-4.2 ± 14.46
Aspartate Aminotransferase (AST), Baseline24.1 ± 13.480 ± 0
Aspartate Aminotransferase (AST), Visit 12E - Day 90E22.5 ± 9.36-1.4 ± 14.26
Aspartate Aminotransferase (AST), Visit 16E - Day 180E21.6 ± 8.73-1.9 ± 13.28
Other pre-specifiedObserved and Change From Baseline in Hematology Parameters in Liver Function Tests

Total bilirubin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mg/dL

Time frame:
90 and 180 days
Reported as:
Mean · mg/dL
Observed and Change From Baseline in Hematology Parameters in Liver Function Tests
mg/dLSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Bilirubin, Baseline0.441 ± 0.20530 ± 0
Bilirubin, Visit 12E - Day 900.361 ± 0.1976-0.077 ± 0.1629
Bilirubin, Visit 16E - EOYDay 1800.431 ± 0.2383-0.004 ± 0.1863
Other pre-specifiedObserved and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period.

Hemoglobin in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of g/dL.

Time frame:
90 and 180 days
Reported as:
Mean · g/dL
Observed and Change From Baseline in Hematology Parameters (Hemoglobin) in SOV2012-F1 Treated Subjects During the Treatment Period.
g/dLSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Hemoglobin, Baseline14.72 ± 1.0940 ± 0
Hemoglobin, Visit 12E - Day 90E15.13 ± 1.4880.41 ± 1.082
Hemoglobin, Visit 16E - EOT Day 180E15.19 ± 1.4900.48 ± 1.068
Other pre-specifiedObserved and Change From Baseline in Hormone Levels.

Luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\] in SOV2012-F1 treated subjects during the treatment period, measurement units of mIU/mL.

Time frame:
90 and 180 days
Reported as:
Mean · mIU/mL
Observed and Change From Baseline in Hormone Levels.
mIU/mLSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Luteinizing Hormone, Baseline5.91 ± 4.1190 ± 0
Luteinizing Hormone, Visit 12E - Day 90E2.13 ± 2.534-3.71 ± 4.410
Luteinizing Hormone, Visit 16E - EOT Day 180E2.39 ± 2.821-3.37 ± 4.342
Follicle Stimulating Hormone, Baseline5.83 ± 4.8900 ± 0
Follicle Stimulating Hormone, Visit 12E - Day 90E2.47 ± 3.037-3.28 ± 4.506
Follicle Stimulating Hormone, Visit 16E - EOT Day 180E2.52 ± 3.073-3.19 ± 4.457
Other pre-specifiedObserved and Change From Baseline in Hormone Levels for SHBG.

Sex hormone-binding globulin \[SHBG\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of nmol/L.

Time frame:
90 and 180 days
Reported as:
Mean · nmol/L
Observed and Change From Baseline in Hormone Levels for SHBG.
nmol/LSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Sex Hormone Binding Globulin, Baseline28.81 ± 14.1930 ± 0
Sex Hormone Binding Globulin, Visit 12E - Day 90E20.30 ± 12.254-8.53 ± 7.901
Sex Hormone Binding Globulin, Visit 16E - EOT Day 180E18.97 ± 11.385-10.45 ± 8.630
Other pre-specifiedObserved and Change From Baseline in Thyrotropin

Thyroid stimulating hormone \[TSH\] in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of mU/L.

Time frame:
90 and 180 days
Reported as:
Mean · mU/L
Observed and Change From Baseline in Thyrotropin
mU/LSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Thyrotropin, Baseline3.014 ± 6.84920 ± 0
Thyrotropin, Visit 12E - Day 90E2.985 ± 3.9809-0.101 ± 5.9459
Thyrotropin, Visit 16E - EOT Day 180E2.263 ± 1.25600.003 ± 1.0863
Other pre-specifiedObserved and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.

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.

Time frame:
90 and 180 days
Reported as:
Mean · mg/dL
Observed and Change From Baseline in Lipid Profiles in SOV2012-F1 Treated Subjects During the Treatment Period.
mg/dLSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Cholesterol, Baseline186.4 ± 38.380 ± 0
Cholesterol, Visit 12E - Day 90E171.7 ± 40.52-14.5 ± 31.69
Cholesterol, Visit 16E - EOT Day 180E176.2 ± 41.62-11.1 ± 30.50
HDL Cholesterol, Baseline45.3 ± 11.940 ± 0
HDL Cholesterol, Visit 12E - Day 90E37.2 ± 9.74-7.8 ± 7.75
HDL Cholesterol, Visit 16E - EOT Day 180E38.2 ± 10.37-6.9 ± 8.70
LDL Cholesterol, Baseline120.8 ± 35.850 ± 0
LDL Cholesterol, Visit 12E - Day 90E113.4 ± 37.52-7.8 ± 27.57
LDL Cholesterol, Visit 16E - EOT Day 180E117.7 ± 38.20-4.0 ± 29.14
Triglycerides, Baseline179.3 ± 123.600 ± 0
Triglycerides, Visit 12E - Day 90E158.9 ± 83.79-16.7 ± 101.61
Triglycerides, Visit 16E - EOT Day 180E160.1 ± 102.90-18.6 ± 106.48
Other pre-specifiedObserved and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period.

Serum prostate-specific antigen (PSA) in SOV2012-F1 treated subjects were assessed during the treatment period, measurement units of ng/mL.

Time frame:
90 and 180 days
Reported as:
Mean · ng/mL
Observed and Change From Baseline in Serum Prostate-specific Antigen (PSA) in SOV2012-F1 Treated Subjects During the Treatment Period.
ng/mLSOV2012-F1-treated, ObservedSOV2012-F1-treated, Change From Baseline
Prostate Specific Antigen, Baseline0.98 ± 0.6510 ± 0
Prostate Specific Antigen, Visit 12E - Day 90E1.10 ± 0.7190.15 ± 0.309
Prostate Specific Antigen, Visit 16E - EOT Day 180E1.09 ± 0.7430.15 ± 0.443

Adverse events

Collected over 180 days. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SOV2012-F1-treated0/155 (0%)2/155 (1.3%)30/155 (19.4%)
Most frequent serious events
Most frequent serious events
EventSOV2012-F1-treated
Atrial fibrillationCardiac disorders1/155
Diverticular perforationGastrointestinal disorders1/155
Most frequent other events
Most frequent other events
EventSOV2012-F1-treated
Upper Respiratory Tract InfectionInfections and infestations8/155
Viral upper respiratory tract infectionInfections and infestations5/155
HypertensionVascular disorders4/155
InfluenzaInfections and infestations4/155
BronchitisInfections and infestations3/155
Hemoglobin increasedInvestigations3/155
HeadacheNervous system disorders3/155

Baseline characteristics

Age, Continuous
Age, Continuous(years)SOV2012-F1-treated
Mean50.5 ± 9.41
Sex: Female, Male
Sex: Female, Male(Participants)SOV2012-F1-treated
Female0
Male155
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SOV2012-F1-treated
Hispanic or Latino54
Not Hispanic or Latino99
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SOV2012-F1-treated
American Indian or Alaska Native1
Asian4
Native Hawaiian or Other Pacific Islander0
Black or African American29
White119
More than one race0
Unknown or Not Reported2
Weight at Baseline
Weight at Baseline(Participants)SOV2012-F1-treated
<= 93 kg59
> 93 kg96
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)SOV2012-F1-treated
Mean33.95 ± 7.343
Assigned breakfast diet
Assigned breakfast diet(Participants)SOV2012-F1-treated
Low-fat breakfast13
Normal-fat breakfast53
High-fat breakfast80
Missing9
Diabetic Status
Diabetic Status(Participants)SOV2012-F1-treated
With Diabetes Mellitus34
Without Diabetes Mellitus121

3 further baseline measures are reported on the registry.

07

Study locations

19 sites
  • Alabama Clinical Therapeutics, LLC
    Birmingham, Alabama 35235, United States
  • Coastal Clinic Research Inc
    Mobile, Alabama 36608, United States
  • South Florida Medical Research
    Aventura, Florida 33180, United States
  • PAB Clinical Research
    Brandon, Florida 33511, United States
  • Jacksonville Impotence Treatment Center
    Jacksonville, Florida 32223, United States
  • My Community Research Center
    Miami, Florida 33155, United States
  • Oviedo Medical Research, LLC
    Oviedo, Florida 32765, United States
  • Meridien Research
    Saint Petersburg, Florida 33709, United States
  • Northwest Clinical Trials
    Boise, Idaho 83704, United States
  • Centex Studies, Inc.
    Lake Charles, Louisiana 70601, United States
  • Quality Clinical Research, Inc.
    Omaha, Nebraska 68114, United States
  • Palm Research Center, Inc.
    Las Vegas, Nevada 89148, United States
  • Accumed Research Associates
    Garden City, New York 11530, United States
  • Manhattan Medical Research Practice, PLLC
    New York, New York 10016, United States
  • Rapha Institute for Clinical Research
    Fayetteville, North Carolina 28314, United States
  • Urologic Consultant of SE Pennyslvania
    Bala-Cynwyd, Pennsylvania 19004, United States
  • Coastal Carolina Research Center
    Mount Pleasant, South Carolina 29464, United States
  • University Diabetes Endocrine Consultants
    Chattanooga, Tennessee 37411, United States
  • Centex Studies, Inc.
    Houston, Texas 77058, United States
08

References and documents

Study documents

  • Study protocol · Feb 18, 2019
  • Statistical analysis plan · Aug 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT04467697
Lead sponsor
Marius Pharmaceuticals
Collaborators
Syneos Health
Responsible party
Sponsor
First posted
Jul 13, 2020
Start date
Sep 18, 2018
Primary completion
May 1, 2020
Completion
May 1, 2020
Results posted
Jun 28, 2024
Last update
Jun 28, 2024

Study contacts

Alistair Smith, MB, ChB
study director · Syneos Health
Om Dhingra, PhD
study chair · Marius Pharmaceuticals

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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