A Phase 3 interventional study of SOV2012-F1 and AndroGel in Hypogonadism, Male, sponsored by Marius Pharmaceuticals. Completed at 36 sites in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Marius Pharmaceuticals · Phase 3, Interventional, and Treatment
This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.
MRS-TU-2019 was a 12-month study designed to determine the efficacy of oral SOV2012-F1 as measured by the percentage of male hypogonadal subjects with average total testosterone (T Cavg) in plasma within the normal range after 90 days of treatment. This study included an AndroGel™ arm as a safety comparator; after the 90-day efficacy period, dosing continued for 9 additional months in both arms to gather safety data. This study also examined the percentage of SOV2012-F1-treated subjects with maximum total testosterone (Cmax) in plasma values after 90 days of treatment: a. ≤1.5 X upper limit of normal (ULN); b. 1.8 X ULN to 2.5 X ULN' and c. >2.5 X ULN. The study also included an adrenal cortical function substudy conducted in 30 SOV2012-F1 subjects and 15 AndroGel subjects. Four patient-reported outcome measures were also used during the study: IPSS, PDQ, SF-36 and IIEF.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's enrollment of 314 is above the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →Marius Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Clinically significant abnormal laboratory values at screening including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
200 patients treated with SOV2012-F1, starting dose of 600 mg - (400 mg with morning meal and 200 mg with evening meal). Dose titrated on Days 28 and 56 up to a maximum of 600 mg TU in the morning and 400 mg in the evening or down to 200 mg TU in the morning based on plasma T at Days 14 and 42.
Drug: SOV2012-F1
100 patients treated with AndroGel, starting dose of 40.5 mg QD. Dose titrated according to approved label, using samples from Days 14 and 42 and dose adjustments on Days 28 and 56.
Drug: AndroGel
oral preparation of testosterone undecanoate (TU)
topical testosterone gel 1.62%
Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1.
Efficacy assessment includes T Cavg calculated from NaF/EDTA plasma testosterone. The T Cavg is calculated as the 24-hour area under the curve (AUC), divided by 24, at Day 90, based on a fifteen blood samples (PK samples) taken over the 24-hours. The T concentration in each sample is measured using a validated LC-MS/MS method. The use of NaF/EDTA plasma tubes chilled after sample collection provides the most accurate values, as the prodrug TU may degrade post-sample collection, artificially inflating testosterone values.
Time frame: 90 days
Percentages of Participants in Each Category for Maximum Plasma Concentration
To determine the percentage of treated subjects with maximum plasma testosterone concentration (T Cmax) values (a) \< 1.5X Upper Limit of Normal (ULN); (b) 1.8X to 2.5X ULN; and (c) \> 2.5X ULN. For NaF/EDTA plasma, thresholds are 1200, 1440 and 2000 ng/dL of T. For serum, thresholds are 1500, 1800 and 2500 ng/dL of T. Note that the endpoint concerns only the investigational treatment SOV2012-F1 and the AndroGel results are reported for completeness. The reported percentages do not sum to 100% as the FDA criteria do not specify the percentage of subjects in the window of ≥ 1.5X and ≤ 1.8X the ULN.
Time frame: 90 days
Change From Baseline in the IPSS
Patient reported outcomes will be assessed by the International Prostate Symptom Score (I-PSS) Reporting a score on a scale 0 to 35 (asymptomatic to very symptomatic). Mean change from baseline is reported and is the difference between the score at Baseline (pre-treatment) and at Day 90 and Day 365. Thus, a positive value at Day 90 or Day 365 represents an increase in the score from baseline.
Time frame: Baseline (pre-treatment) to 90 days and 365 days
Change From Baseline in the Psychosexual Daily Questionnaire (PDQ)
Patient reported outcomes are 7-day average score at baseline, and average change from baseline (CfB) at Day 90 and Day 365. Weekly daily average scores calculated for diaries completed at least 3 of 7 days. The three domains are: Sexual desire subscale 0=None, 1=very low to 7=Very High. Sexual enjoyment with/without partner subscale 0=None to 7=Very high enjoyment/pleasure. Partner availability not used in scoring. Positive CfB desirable. Positive and negative mood subscales 0=Not at all true to 7=Very true (Likert 7-point scale, 7-day average reported). Positive mood (sum of 4 questions) score range = 0 to 28; positive changes from baseline desirable. Negative mood (sum of 5 questions) score range = 0 to 35; negative CfB desirable. Weekly sexual activity subscale score is 7\*(# of activities per week / # of days reported). Percent full erection uses scale of 0-100% (10% steps). Satisfaction with erection 0=not satisfactory to 7=very satisfactory. Positive CfB desirable.
Time frame: Baseline (pre-treatment) to 90 days and 365 days
Change From Baseline in the SF-36
Patient reported outcomes assessed by the Short-Form Survey (SF-36). This scale assesses 8 health concepts: 1. limitations in physical activities because of health problems 2. limitations in social activities because of physical or emotional problems 3. limitations in usual role activities because of physical health problems 4. bodily pain 5. general mental health (psychological distress and well-being) 6. limitations in usual role activities because of emotional problems 7. vitality (energy and fatigue) 8. general health perceptions. Each domain is scored from 0-100 with a score of 0 = maximum disability and a score of 100 = no disability. End of Treatment (EOT) occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure towards less disability. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and EOT scores.
Time frame: Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT)
Change From Baseline in the IIEF
Patient reported outcomes are assessed by the International Index of Erectile Function (IIEF). A score of 0-5 (higher score indicating improvement) is awarded to each of the 15 questions that examine overall satisfaction (2 questions, total possible score=10), and the 4 main domains of male sexual function: erectile function (6 questions, total possible score=30), orgasmic function (2 questions, total possible score=10), sexual desire (2 questions, total possible score=10), and intercourse satisfaction (3 questions, total possible score=15). The IIEF results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment (EOT). EOT occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and End of Treatment scores.
Time frame: Baseline (Day 1, pre-treatment) and change from baseline at the End of Treatment (EOT)
Change From Baseline in Fasting Serum Glucose (FSG) Concentration
The measured value is the FSG concentration reported as mg/dL. The FSG results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.
Change From Baseline in Fasting Insulin Concentration
The measured value is the insulin concentration reported as in units of uU/mL. The insulin results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.
Change From Baseline in Blood Pressures After Oral Testosterone Undecanoate and Testosterone Gel
Changes from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), as mmHg. The blood pressure results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the measured SBP or DBP.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.
Change From Baseline in Liver Function Tests
Liver function tests (ALT, AST, total bilirubin, alkaline phosphatase). The liver function test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the liver function test value
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.
Change in Bilirubin
Change in bilirubin from Baseline The bilirubin test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the bilirubin value.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment.
Change From Baseline in Hematology Parameters
Hematology parameters (HbA1c) with diabetes mellitus and Without diabetes mellitus. The HbA1c test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value at End of Treatment is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the End of Treatment value. Normal range for HbA1c is 4 to 5.6%, pre-diabetic is 5.7 to 6.4%, and diabetic is equal to or greater than 6.5%.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment
Change From Baseline in Hormone Levels
Hormone levels (luteinizing hormone \[LH\], follicle-stimulating hormone \[FSH\], sex hormone-binding globulin \[SHBG\], TSH). The hormone level test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the hormone level.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment
Change in Hormone SHBG
Change in hormone Sex Hormone Binding Globulin (SHBG). The hormone level test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the hormone level.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment
Change in TSH (Thyrotropin)
Change from Baseline in Thyroid stimulating Hormone (TSH). The TSH test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the TSH level.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment
Change From Baseline in Lipid Profiles
Lipid profiles (high and low-density lipoproteins, total cholesterol, triglycerides). The lipid test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment. End of Treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the lipid value.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment
Change From Baseline in PSA
Serum prostate-specific antigen (PSA). The PSA results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment. End of Treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the PSA value.
Time frame: Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment
Effect of SOV2012-F1 on Adrenal Cortical Function as Assessed by Measuring the Cortisol Response to Synthetic ACTH at Baseline in Subjects
To determine the effect of SOV2012-F1 on adrenal cortical function as assessed by measuring the cortisol response to synthetic ACTH at baseline and after 52 weeks of treatment in a subset of SOV2012-F1 subjects. . The sample size was calculated based on a assumed common Standard Deviation of 93 nmol/L to yield a half-width of not more than 60 nmol/L; hence a sample size of 30 was targeted for the investigational (SOV2012-F1) arm, and 15 for the safety control arm (AndroGel).
Time frame: 52 weeks
| Milestone | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Started | 214 | 100 |
| Completed | 162 | 76 |
| Not completed | 52 | 24 |
| Withdrew: Adverse event | 10 | 5 |
| Withdrew: Lost to follow-up | 21 | 7 |
| Withdrew: Physician decision | 7 | 2 |
| Withdrew: Withdrawal by subject | 14 | 10 |
Efficacy assessment includes T Cavg calculated from NaF/EDTA plasma testosterone. The T Cavg is calculated as the 24-hour area under the curve (AUC), divided by 24, at Day 90, based on a fifteen blood samples (PK samples) taken over the 24-hours. The T concentration in each sample is measured using a validated LC-MS/MS method. The use of NaF/EDTA plasma tubes chilled after sample collection provides the most accurate values, as the prodrug TU may degrade post-sample collection, artificially inflating testosterone values.
| Participants | SOV2012-F1 Treated |
|---|---|
| Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1. | 166 |
To determine the percentage of treated subjects with maximum plasma testosterone concentration (T Cmax) values (a) \< 1.5X Upper Limit of Normal (ULN); (b) 1.8X to 2.5X ULN; and (c) \> 2.5X ULN. For NaF/EDTA plasma, thresholds are 1200, 1440 and 2000 ng/dL of T. For serum, thresholds are 1500, 1800 and 2500 ng/dL of T. Note that the endpoint concerns only the investigational treatment SOV2012-F1 and the AndroGel results are reported for completeness. The reported percentages do not sum to 100% as the FDA criteria do not specify the percentage of subjects in the window of ≥ 1.5X and ≤ 1.8X the ULN.
| percentage of actual number of subjects | SOV2012-F1 Treated | Andro-gel™ Treated |
|---|---|---|
| T Cmax < 1200 ng/dL for SOV2012-F1; T Cmax < 1500 ng/dL for Andro-gel after 90 days | 76.9 | 92.2 |
| T Cmax 1440 to 2000 ng/dL for SOV2012-F1; T Cmax 1800 to 2500 ng/dL for Andro-gel after 90 days | 7.5 | 2.2 |
| T Cmax > 2000 ng/dL for SOV2012-F1; T Cmax > 2500 ng/dL for Andro-gel after 90days | 3.2 | 1.1 |
Patient reported outcomes will be assessed by the International Prostate Symptom Score (I-PSS) Reporting a score on a scale 0 to 35 (asymptomatic to very symptomatic). Mean change from baseline is reported and is the difference between the score at Baseline (pre-treatment) and at Day 90 and Day 365. Thus, a positive value at Day 90 or Day 365 represents an increase in the score from baseline.
| score on a scale | SOV2012-F1 Treated | Andro-gel™ Treated |
|---|---|---|
| Baseline | 4.4 ± 4.12 | 5.4 ± 4.94 |
| Change from baseline (Visit 8 - Day 90) | 0.2 ± 3.56 | 0.7 ± 3.72 |
| Change from baseline (Visit Day 365) | 0.6 ± 3.99 | 1.0 ± 3.73 |
Patient reported outcomes are 7-day average score at baseline, and average change from baseline (CfB) at Day 90 and Day 365. Weekly daily average scores calculated for diaries completed at least 3 of 7 days. The three domains are: Sexual desire subscale 0=None, 1=very low to 7=Very High. Sexual enjoyment with/without partner subscale 0=None to 7=Very high enjoyment/pleasure. Partner availability not used in scoring. Positive CfB desirable. Positive and negative mood subscales 0=Not at all true to 7=Very true (Likert 7-point scale, 7-day average reported). Positive mood (sum of 4 questions) score range = 0 to 28; positive changes from baseline desirable. Negative mood (sum of 5 questions) score range = 0 to 35; negative CfB desirable. Weekly sexual activity subscale score is 7\*(# of activities per week / # of days reported). Percent full erection uses scale of 0-100% (10% steps). Satisfaction with erection 0=not satisfactory to 7=very satisfactory. Positive CfB desirable.
| score on a scale | SOV2012-F1 Treated | Andro-gel™ Treated |
|---|---|---|
| Overall Level of sexual desire Visit 3 - Day 1 (baseline) | 1.990 ± 1.4195 | 2.039 ± 1.5659 |
| Overall Level of sexual desire Visit 8 - Day 90 | 1.674 ± 1.6851 | 1.256 ± 1.5583 |
| Overall Level of sexual desire Visit Day 365 | 1.552 ± 1.7596 | 1.372 ± 1.6968 |
| Without a Partner Visit 3 - Day 1 (baseline) | 0.754 ± 0.9640 | 0.875 ± 1.1397 |
| Without a Partner Visit 8 - Day 90 | 0.742 ± 1.6478 | 0.498 ± 1.2075 |
| Without a Partner Visit Day 365 | 0.920 ± 1.5566 | 0.769 ± 1.5840 |
| With a Partner Visit 3 - Day 1 (baseline) | 0.954 ± 1.2033 | 0.840 ± 1.2928 |
| With a Partner Visit 8 - Day 90 | 1.168 ± 1.7335 | 0.594 ± 1.7373 |
| With a Partner Visit Day 365 | 1.106 ± 1.6670 | 0.760 ± 1.8284 |
| Negative Mood Visit 3 - Day 1 (baseline) | 9.258 ± 5.8557 | 9.847 ± 5.0938 |
| Negative Mood Visit 8 - Day 90 | -2.205 ± 5.6199 | -1.886 ± 5.5670 |
| Negative Mood Visit Day 365 | -3.011 ± 5.3399 | -1.435 ± 5.7065 |
| Positive mood - Visit 3 - Day 1 (baseline) | 16.799 ± 5.1778 | 15.742 ± 5.5015 |
| Positive mood - Visit 8 - Day 90 | 2.513 ± 5.0149 | 3.347 ± 5.2716 |
| Positive mood - Day 365 | 3.407 ± 5.1065 | 2.817 ± 5.1714 |
| Sexual Activity Score Visit 3 - Day 1 (baseline) | 15.314 ± 13.8521 | 12.581 ± 12.0706 |
| Sexual Activity Score Visit 8 - Day 90 | 12.284 ± 15.9338 | 10.951 ± 17.4041 |
| Sexual Activity Score Day 365 | 12.009 ± 16.5438 | 12.591 ± 17.7272 |
| Erection Grade, Visit 3 - Day 1 (baseline) | 32.145 ± 22.9941 | 30.652 ± 23.9078 |
| Erection Grade, Visit 8 - Day 90 | 17.494 ± 25.0678 | 12.619 ± 22.6952 |
| Erection Grade, Day 365 | 14.235 ± 28.9806 | 17.584 ± 23.1670 |
| Erection Duration, Visit 3 - Day 1 (baseline) | 1.985 ± 1.4894 | 1.814 ± 1.5321 |
| Erection Duration, Visit 8 - Day 90 | 1.480 ± 1.7137 | 1.012 ± 1.7166 |
| Erection Duration, Day 365 | 1.300 ± 1.8420 | 1.501 ± 1.6751 |
Patient reported outcomes assessed by the Short-Form Survey (SF-36). This scale assesses 8 health concepts: 1. limitations in physical activities because of health problems 2. limitations in social activities because of physical or emotional problems 3. limitations in usual role activities because of physical health problems 4. bodily pain 5. general mental health (psychological distress and well-being) 6. limitations in usual role activities because of emotional problems 7. vitality (energy and fatigue) 8. general health perceptions. Each domain is scored from 0-100 with a score of 0 = maximum disability and a score of 100 = no disability. End of Treatment (EOT) occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure towards less disability. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and EOT scores.
| score on a scale | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Emotional Well-being (Baseline) | 72.4 ± 17.55 | 68.0 ± 18.98 |
| Emotional Well-being (End of Treatment) | 7.1 ± 15.44 | 5.6 ± 15.37 |
| Energy/Fatigue (Baseline) | 61.0 ± 20.22 | 53.0 ± 21.91 |
| Energy/Fatigue (End of Treatment) | 16.6 ± 21.00 | 15.5 ± 21.12 |
| General Health (Baseline) | 69.0 ± 17.09 | 67.0 ± 18.33 |
| General Health (End of Treatment) | 3.5 ± 16.87 | 6.9 ± 15.46 |
| Health Change (Baseline) | 65.2 ± 20.66 | 59.6 ± 18.66 |
| Health Change (End of Treatment) | 14.6 ± 26.81 | 7.0 ± 24.16 |
| Pain (Baseline) | 77.17 ± 21.103 | 70.57 ± 22.619 |
| Pain (End of Treatment) | 4.16 ± 21,778 | 1.43 ± 21.834 |
| Physical Functioning (Baseline) | 85.5 ± 19.03 | 83.3 ± 19.05 |
| Physical Functioning (End of Treatment) | 3.6 ± 17.57 | 6.8 ± 19.82 |
| Role Limitations due to Emotional Problems (Baseline) | 85.317 ± 30.2358 | 79.116 ± 34.4177 |
| Role Limitations due to Emotional Problems (End of Treatment) | 12.081 ± 39.3671 | 5.778 ± 35.2483 |
| Role Limitations due to Physical Health (Baseline) | 82.1 ± 31.09 | 75.0 ± 35.14 |
| Role Limitations due to Physical Health (End of Treatment) | 12.4 ± 41.06 | 14.3 ± 39.67 |
| Social Functioning (Baseline) | 84.75 ± 18.527 | 83.73 ± 18.799 |
| Social Functioning (End of Treatment) | 9.31 ± 22.140 | 6.83 ± 22.161 |
| Mental Health Composite (Baseline) | 51.885 ± 8.6492 | 49.025 ± 10.5313 |
| Mental Health Composite (End of Treatment) | 5.478 ± 9.8093 | 3.515 ± 9.1373 |
| Physical Health Composite (Baseline) | 49.229 ± 8.3286 | 48.002 ± 8.7737 |
| Physical Health Composite (End of Treatment) | 1.558 ± 7.5381 | 2.968 ± 8.1428 |
Patient reported outcomes are assessed by the International Index of Erectile Function (IIEF). A score of 0-5 (higher score indicating improvement) is awarded to each of the 15 questions that examine overall satisfaction (2 questions, total possible score=10), and the 4 main domains of male sexual function: erectile function (6 questions, total possible score=30), orgasmic function (2 questions, total possible score=10), sexual desire (2 questions, total possible score=10), and intercourse satisfaction (3 questions, total possible score=15). The IIEF results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment (EOT). EOT occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. A positive value at EOT indicates improvement in the measure. The EOT Change from Baseline is simply the arithmetic difference between the Baseline and End of Treatment scores.
| score on a scale | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Erectile Function (Baseline) | 19.8 ± 8.99 | 17.1 ± 9.62 |
| Erectile Function (End of Treatment) | 5.1 ± 8.30 | 4.1 ± 8.35 |
| Intercourse Satisfaction (Baseline) | 8.4 ± 5.17 | 6.8 ± 5.55 |
| Intercourse Satisfaction (End of Treatment) | 2.4 ± 4.56 | 2.4 ± 4.81 |
| Orgasmic Function (Baseline) | 7.3 ± 3.45 | 6.7 ± 3.42 |
| Orgasmic Function (End of Treatment) | 1.5 ± 3.61 | 2.4 ± 4.81 |
| Sexual Desire (Baseline) | 3.6 ± 1.12 | 3.7 ± 1.10 |
| Sexual Desire (End of Treatment) | 0.7 ± 1.25 | 0.9 ± 1.10 |
| Overall Satisfaction (Baseline) | 4.8 ± 2.31 | 4.1 ± 2.27 |
| Overall Satisfaction Visit Day 365 | 2.3 ± 2.55 | 1.6 ± 2.83 |
The measured value is the FSG concentration reported as mg/dL. The FSG results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values.
| mg/dL | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Baseline | 108.6 ± 31.19 | 110.3 ± 26.01 |
| Visit 8 - Day 90 | 4.2 ± 24.84 | 3.0 ± 23.51 |
| Visit 10 - Day 180 | 1.4 ± 24.54 | 2.4 ± 21.48 |
| Visit 12 - Day 270 | 1.4 ± 21.82 | 6.2 ± 31.97 |
| End of Treatment | -4.7 ± 20.41 | -0.8 ± 21.61 |
The measured value is the insulin concentration reported as in units of uU/mL. The insulin results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and measured values.
| uU/mL | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Baseline | 27.30 ± 38.030 | 24.83 ± 18.555 |
| Visit 8 - Day 90 | 3.59 ± 56.110 | 2.43 ± 19.328 |
| Visit 10 - Day 180 | 2.77 ± 54.045 | 5.12 ± 46.035 |
| Visit 12 - Day 270 | 5.12 ± 63.889 | 0.54 ± 20.026 |
| End of Treatment | -5.24 ± 43.047 | -2.58 ± 14.967 |
Changes from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), as mmHg. The blood pressure results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the measured SBP or DBP.
| mmHg | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Clinic systolic BP - Baseline | 125.8 ± 9.122 | 125.95 ± 10.130 |
| Clinic systolic BP - 90 day | 2.16 ± 10.400 | 3.07 ± 9.797 |
| Clinic systolic BP - 180 day | 1.89 ± 10.174 | 1.91 ± 9.044 |
| Clinic systolic BP - 365 day | 2.75 ± 9.501 | 3.38 ± 10.492 |
| Clinic diastolic BP - Baseline | 78.88 ± 6.340 | 79.19 ± 6.624 |
| Clinic diastolic BP - 90 day | 0.58 ± 6.800 | 1.10 ± 8.262 |
| Clinic diastolic BP - 180 day | 0.67 ± 6.014 | 2.60 ± 6.826 |
| Clinic diastolic BP - 365 day | 1.14 ± 6.119 | 1.75 ± 7.213 |
Liver function tests (ALT, AST, total bilirubin, alkaline phosphatase). The liver function test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the liver function test value
| U/L | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Alkaline Phosphatase (Baseline) | 72.8 ± 18.79 | 74.0 ± 20.19 |
| Alkaline Phosphatase (Visit 8 - Day 90) | -6.0 ± 11.03 | -1.2 ± 8.90 |
| Alkaline Phosphatase (Visit 10 - Day 180) | -4.2 ± 12.14 | -1.6 ± 10.13 |
| Alkaline Phosphatase (Visit 12 - Day 270) | -5.5 ± 10.57 | -2.1 ± 9.96 |
| Alkaline Phosphatase (Visit Day 365) | -4.5 ± 11.42 | -1.5 ± 10.38 |
| Alkaline Phosphatase (End of Treatment) | -4.0 ± 11.31 | -1.5 ± 10.37 |
| Alanine Aminotransferase (ALT) - Baseline | 30.5 ± 13.59 | 31.0 ± 12.64 |
| Alanine Aminotransferase (ALT), Visit 8 - Day 90 | -2.6 ± 14.28 | -0.0 ± 13.30 |
| Alanine Aminotransferase (ALT), Visit 10 - Day 180 | -2.9 ± 11.44 | 0.9 ± 16.64 |
| Alanine Aminotransferase (ALT), Visit 12 - Day 270 | -2.2 ± 12.76 | 0.7 ± 17.25 |
| Alanine Aminotransferase (ALT), Visit Day 365 | -1.4 ± 12.89 | 1.3 ± 14.55 |
| Alanine Aminotransferase (ALT) - End of Treatment | -0.4 ± 19.84 | 0.9 ± 14.64 |
| Aspartate Aminotransferase (AST) - Baseline | 23.8 ± 8.83 | 23.4 ± 8.04 |
| Aspartate Aminotransferase (AST) - Visit 8, Day 90 | 0.8 ± 10.96 | 1.2 ± 8.34 |
| Aspartate Aminotransferase (AST) - Visit 10, Day 180 | 0.1 ± 8.04 | 1.7 ± 12.24 |
| Aspartate Aminotransferase (AST) - Visit 12, Day 270 | 0.0 ± 9.03 | 0.3 ± 11.27 |
| Aspartate Aminotransferase (AST) - Visit Day 365 | 2.2 ± 27.18 | 1.2 ± 9.64 |
| Aspartate Aminotransferase (AST) - End of Treatment | 2.4 ± 27.18 | 1.0 ± 9.69 |
Change in bilirubin from Baseline The bilirubin test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270 and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the bilirubin value.
| mg/dL | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Bilirubin - Baseline | 0.491 ± 0.2437 | 0.465 ± 0.2561 |
| Bilirubin, Visit 8 - Day 90 | -0.088 ± 0.2024 | -0.058 ± 0.2231 |
| Bilirubin, Visit 10 - Day 180 | -0.007 ± 0.2350 | -0.004 ± 0.2106 |
| Bilirubin, Visit 12 - Day 270 | 0.013 ± 0.2254 | 0.029 ± 0.2171 |
| Bilirubin, Visit Day 365 | -0.027 ± 0.2155 | 0.038 ± 0.2245 |
| Bilirubin, End of Treatment | -0.032 ± 0.2157 | 0.026 ± 0.2117 |
Hematology parameters (HbA1c) with diabetes mellitus and Without diabetes mellitus. The HbA1c test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value at End of Treatment is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the End of Treatment value. Normal range for HbA1c is 4 to 5.6%, pre-diabetic is 5.7 to 6.4%, and diabetic is equal to or greater than 6.5%.
| percentage of HbA1c | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| HbA1c with diabetes mellitus (baseline) | 7.20 ± 0.515 | 7.07 ± 0.340 |
| HbA1c with diabetes mellitus end of treatment | 0.04 ± 0.975 | 0.73 ± 0.608 |
| HbA1c without diabetes mellitus (baseline) | 5.63 ± 0.432 | 5.65 ± 0.469 |
| HbA1c without diabetes mellitus end of treatment | 0.11 ± 0.369 | 0.00 ± 0.326 |
Hormone levels (luteinizing hormone \[LH\], follicle-stimulating hormone \[FSH\], sex hormone-binding globulin \[SHBG\], TSH). The hormone level test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the hormone level.
| mIU/mL | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Follicle Stimulating Hormone (FSH) - Baseline | 5.46 ± 5.496 | 5.03 ± 3.283 |
| Follicle Stimulating Hormone (FSH) - Visit 8 - Day 90 | -3.35 ± 4.423 | -3.28 ± 2.888 |
| Follicle Stimulating Hormone (FSH) - Visit Day 365 | -2.72 ± 4.209 | -1.82 ± 6.708 |
| Follicle Stimulating Hormone (FSH) - Visit Day 365 End of Treatment | -2.45 ± 4.162 | -1.77 ± 6.230 |
| Luteinizing Hormone (LH) - Baseline | 4.82 ± 3.755 | 4.58 ± 2.494 |
| Luteinizing Hormone (LH) - Visit 8 - Day 90 | -3.25 ± 3.805 | -3.28 ± 2.472 |
| Luteinizing Hormone (LH) - Visit Day 365 | -2.53 ± 3.487 | -1.67 ± 4.484 |
| Luteinizing Visit Day Hormone (LH) - End of Treatment | -2.18 ± 3.582 | -1.60 ± 4.272 |
Change in hormone Sex Hormone Binding Globulin (SHBG). The hormone level test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the hormone level.
| nmol/L | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| SHBG - Baseline | 27.08 ± 11.958 | 24.52 ± 10.210 |
| SHBG - Day 90 | -8.99 ± 8.167 | 0.26 ± 4.341 |
| SHBG - Day 365 | -7.00 ± 9.326 | 1.60 ± 8.126 |
| SHBG - End of Treatment | -6.25 ± 9.637 | 1.39 ± 7.595 |
Change from Baseline in Thyroid stimulating Hormone (TSH). The TSH test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, and the End of Treatment. End of treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value at Day 90 or Day 365. A positive value for Change in Baseline represents an increase in the TSH level.
| mU/L | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Thyrotropin - Baseline | 2.212 ± 1.1941 | 2.407 ± 1.2624 |
| Thyrotropin - Day 90 | 0.293 ± 1.0140 | 0.343 ± 1.0773 |
| Thyrotropin - Day 365 | 0.195 ± 1.1494 | 0.122 ± 1.0080 |
| Thyrotropin - End of Treatment | 0.209 ± 1.1204 | 0.081 ± 1.0571 |
Lipid profiles (high and low-density lipoproteins, total cholesterol, triglycerides). The lipid test results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment. End of Treatment occurred either at time of early withdrawal from the study or at Day 365. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the lipid value.
| mg/dL | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Cholesterol, Baseline | 190.5 ± 38.55 | 191.1 ± 39.12 |
| Cholesterol, Visit 8 Day 90 | -8.6 ± 29.86 | -6.1 ± 26.36 |
| Cholesterol, Visit 10 Day 180 | -10.7 ± 29.56 | -5.7 ± 25.07 |
| Cholesterol, Visit 12 Day 270 | -14.3 ± 32.28 | -8.2 ± 31.83 |
| Cholesterol, Visit Day 365 | -14.0 ± 28.72 | -5.5 ± 38.41 |
| Cholesterol, End of Treatment | -11.6 ± 30.56 | -6.0 ± 36.24 |
| HDL Cholesterol, Baseline | 46.8 ± 11.84 | 45.2 ± 11.33 |
| HDL Cholesterol, Visit 8, Day 90 | -7.5 ± 8.45 | -1.5 ± 6.79 |
| HDL Cholesterol, Visit 10, Day 180 | -6.9 ± 9.96 | -1.9 ± 6.94 |
| HDL Cholesterol, Visit 12, Day 270 | -6.7 ± 9.53 | -1.6 ± 7.62 |
| HDL Cholesterol, Visit Day 365 | -7.9 ± 9.83 | -2.8 ± 7.12 |
| HDL Cholesterol, End of Treatment | -7.1 ± 9.87 | -2.8 ± 7.05 |
| LDL Cholesterol, Baseline 1 | 110.8 ± 34.72 | 108.9 ± 34.39 |
| LDL Cholesterol, Visit 8 - Day 90 | -0.3 ± 26.13 | -4.3 ± 22.91 |
| LDL Cholesterol, Visit 10 - Day 180 | -3.1 ± 25.79 | -5.4 ± 21.92 |
| LDL Cholesterol, Visit 12 - Day 270 | -6.1 ± 27.90 | -5.4 ± 26.84 |
| LDL Cholesterol, Visit Day 365 | -4.8 ± 25.06 | -5.4 ± 30.42 |
| LDL Cholesterol, End of Treatment | -3.8 ± 25.92 | -5.5 ± 29.41 |
| Triglycerides, Baseline | 167.6 ± 86.30 | 184.6 ± 86.79 |
| Triglycerides, Visit 8 - Day 90 | -2.5 ± 86.21 | 9.4 ± 100.18 |
| Triglycerides, Visit 10 - Day 180 | -3.2 ± 75.75 | 19.0 ± 99.18 |
| Triglycerides, Visit 12 - Day 270 | -8.0 ± 88.60 | 15.4 ± 126.56 |
| Triglycerides, Visit Day 365 | -7.0 ± 73.84 | 26.0 ± 144.41 |
| Triglycerides, End of Treatment | -4.8 ± 77.97 | 25.9 ± 136.57 |
Serum prostate-specific antigen (PSA). The PSA results are reported at Baseline (Day 1, pre-treatment) and the change from baseline at Day 90, Day 180, Day 270, Day 365 and the End of Treatment. End of Treatment occurred either at time of early withdrawal from the study or at Day 365. The reported value is the change from baseline. The Change from Baseline is simply the arithmetic difference between the Baseline and the measured value. A positive value for Change in Baseline represents an increase in the PSA value.
| ng/mL | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Prostate Specific Antigen, Baseline | 0.87 ± 0.549 | 0.78 ± 0.506 |
| Prostate Specific Antigen, Visit 8 - Day 90 | 0.18 ± 0.452 | 0.18 ± 0.435 |
| Prostate Specific Antigen, Visit 10 - Day 180 | 0.20 ± 0.472 | 0.22 ± 0.533 |
| Prostate Specific Antigen, Visit 12 - Day 270 | 0.25 ± 0.586 | 0.29 ± 0.650 |
| Prostate Specific Antigen, Visit Day 365 | 0.23 ± 0.525 | 0.27 ± 0.756 |
| Prostate Specific Antigen, End of Treatment | 0.23 ± 0.523 | 0.41 ± 1.688 |
To determine the effect of SOV2012-F1 on adrenal cortical function as assessed by measuring the cortisol response to synthetic ACTH at baseline and after 52 weeks of treatment in a subset of SOV2012-F1 subjects. . The sample size was calculated based on a assumed common Standard Deviation of 93 nmol/L to yield a half-width of not more than 60 nmol/L; hence a sample size of 30 was targeted for the investigational (SOV2012-F1) arm, and 15 for the safety control arm (AndroGel).
| nmol/L | SOV2012-F1-Treated | Andro-Gel™ Treated |
|---|---|---|
| Maximum Serum Cortisol (Day 1 - Baseline) | 23.75 ± 3.584 | 25.68 ± 2.373 |
| Maximum Serum Cortisol (Day 365 - End of Study) | 25.22 ± 4.561 | 27.05 ± 3.267 |
Collected over 365 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOV2012-F1-Treated | 1/214 (0.5%) | 9/214 (4.2%) | 53/214 (24.8%) |
| Andro-Gel Treated | 0/100 (0%) | 1/100 (1%) | 25/100 (25%) |
| Event | SOV2012-F1-Treated | Andro-Gel Treated |
|---|---|---|
| Diabetic footSkin and subcutaneous tissue disorders | 1/214 | 1/100 |
| Acute Myocardial infarctionCardiac disorders | 1/214 | 0/100 |
| Atrial fibrillationCardiac disorders | 1/214 | 0/100 |
| Cardiac failure congestiveCardiac disorders | 1/214 | 0/100 |
| Myocardial infarctionCardiac disorders | 1/214 | 0/100 |
| ColitisGastrointestinal disorders | 1/214 | 0/100 |
| HaemorrhoidsGastrointestinal disorders | 1/214 | 0/100 |
| Chest painGeneral disorders | 1/214 | 0/100 |
| CellulitisInfections and infestations | 1/214 | 0/100 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/214 | 0/100 |
| Event | SOV2012-F1-Treated | Andro-Gel Treated |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 15/214 | 12/100 |
| HypertensionVascular disorders | 17/214 | 2/100 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/214 | 6/100 |
| Viral upper respiratory tract infectionInfections and infestations | 7/214 | 5/100 |
| Prostatic specific antigen increasedInvestigations | 5/214 | 5/100 |
| InfluenzaInfections and infestations | 10/214 | 4/100 |
| SinusitisInfections and infestations | 5/214 | 4/100 |
| HeadacheNervous system disorders | 8/214 | 4/100 |
| Blood pressure increasedInvestigations | 7/214 | 3/100 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/214 | 3/100 |
Safety Set
| Age, Continuous(years) | SOV2012-F1-Treated | Andro-Gel™ Treated | Total |
|---|---|---|---|
| Mean | 49.2 ± 9.15 | 50.7 ± 9.30 | 49.7 ± 9.21 |
| Sex: Female, Male(Participants) | SOV2012-F1-Treated | Andro-Gel™ Treated | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 214 | 100 | 314 |
| Ethnicity (NIH/OMB)(Participants) | SOV2012-F1-Treated | Andro-Gel™ Treated | Total |
|---|---|---|---|
| Hispanic or Latino | 55 | 27 | 82 |
| Not Hispanic or Latino | 159 | 73 | 232 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SOV2012-F1-Treated | Andro-Gel™ Treated | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 34 | 11 | 45 |
| White | 171 | 86 | 257 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 1 | 8 |
| Weight at Baseline(kg) | SOV2012-F1-Treated | Andro-Gel™ Treated | Total |
|---|---|---|---|
| Mean | 108.48 ± 22.827 | 108.97 ± 24.544 | 108.63 ± 23.349 |
| Body Mass Index (BMI)(kg/m^2) | SOV2012-F1-Treated | Andro-Gel™ Treated | Total |
|---|---|---|---|
| Mean | 34.12 ± 7.056 | 34.33 ± 6.486 | 34.19 ± 6.870 |
| Assigned breakfast diet(Participants) | SOV2012-F1-Treated | Andro-Gel™ Treated | Total |
|---|---|---|---|
| Low-fat Breakfast | 27 | — | 27 |
| Normal-fat Breakfast | 54 | — | 54 |
| High-fat Breakfast | 130 | — | 130 |
| Missing | 3 | — | 3 |
| Diabetic Status(Participants) | SOV2012-F1-Treated | Andro-Gel™ Treated | Total |
|---|---|---|---|
| With Diabetes Mellitus | 31 | 13 | 44 |
| Without Diabetes Mellitus | 183 | 87 | 270 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2017 to primary completion in May 2020, 33 months.
Results were first posted in Jun 2023, 3 years 1 month after primary completion. A results delay was requested in Jan 2021.
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Marius Pharmaceuticals