Hypogonadism, MalePhase 3NCT04467697
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
A Phase 3 study testing SOV2012-F1 in people with Hypogonadism, Male, run by Marius Pharmaceuticals at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- SOV2012-F1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 19 sitesUnited States
- Study dates
- 18 Sep 2018to 1 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Completion of MRS-TU-2019 Day 365/ End of Treatment
Who cannot join
- Upper arm circumference > 45 cm.
- Long distance driving or planned driving trip (> 60 mins duration where the subject is doing the driving) during period of wearing ABPM cuff.
- Expected / known forthcoming change to antihypertensive medication(s) during the MRS-TU-2019 EXT extension study.
- Cardiac arrhythmias that, in the opinion of the investigator, interfere with the ability of the ABPM recorder to obtain reliable measurements.
- 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 :
Show all 53Show fewer
- MRS-TU-2019 Key Inclusion Criteria:
- Male aged 18 to 65 years, inclusive, at the time of providing informed consent to participate in the study.
- 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.
- 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.
- 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.
- 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:
- Hemoglobin A1c < 8.0%
- 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.
- Low-density lipoprotein cholesterol < 190 mg/dL.
- 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.
- Adequate venous access to allow collection of a number of blood samples via a venous cannula.
- Written informed consent to participate in the study and ability to comply with all study requirements.
- MRS-TU-2019 Key Exclusion Criteria:
- Serum PSA > 2.5 ng/ml and/or abnormal prostate gland on palpation, e.g., palpable nodes, at Screening Visit 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.
- 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.
- 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.
- 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.
- Unstable or chronic disease that could interfere with participation in the study or patient safety, including psychiatric disorders.
- Myocardial infarction, coronary artery surgery, heart failure, stroke, unstable angina, or other unstable cardiovascular disease within the past 6 months.
- Abnormal ECG considered clinically significant by investigator at Screening.
- Diagnosis of any cancer within the previous 5 years other than basal or squamous cell skin cancer with clear margins.
- 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.
- Duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to screening.
- 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
- Human immunodeficiency virus (HIV) infection.
- 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])
- Clinically significant abnormal laboratory values at screening including but not limited to:
- Elevated liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT] > 2X upper limit of normal)
- Estimated glomerular filtration rate < 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease formula
- 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.
- Severe or untreated obstructive sleep apnea syndrome.
- Severe lower urinary tract symptoms (American Urological Association/ IPSS ≥ 19).
- History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study entry.
- Past, current, or suspected prostate or breast cancer.
- History of long QT syndrome or unexplained sudden death in a first-degree relative (parent, sibling, or child).
- 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.
- Subject has a partner who is currently pregnant or planning pregnancy during the course of the study.
- 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.
- History of noncompliance to medical regimens or potential unreliability in the opinion of the investigator.
- Unwilling or unable to comply to the dietary requirements for this study.
- History of polycythemia, either idiopathic or associated with TRT.
- Donated blood (≥ 500 mL) within the 12-week period prior to study entry.
- History of an abnormal bleeding tendency or thrombophlebitis within the previous 2 years that is not linked to venipuncture or intravenous cannulation.
- Onset of gynecomastia within the previous 6 months.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultant of SE Pennyslvania
Bala-Cynwyd, Pennsylvania, 19004
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Northwest Clinical Trials
Boise, Idaho, 83704
PAB Clinical Research
Brandon, Florida, 33511
University Diabetes Endocrine Consultants
Chattanooga, Tennessee, 37411
Rapha Institute for Clinical Research
Fayetteville, North Carolina, 28314
Accumed Research Associates
Garden City, New York, 11530
Centex Studies, Inc.
Houston, Texas, 77058
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223
Centex Studies, Inc.
Lake Charles, Louisiana, 70601
Palm Research Center, Inc.
Las Vegas, Nevada, 89148
My Community Research Center
Miami, Florida, 33155
Coastal Clinic Research Inc
Mobile, Alabama, 36608
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Manhattan Medical Research Practice, PLLC
New York, New York, 10016
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
Meridien Research
St. Petersburg, Florida, 33709
About this study
Official title: A 6 Month, Open Label, Ambulatory Blood Pressure Monitoring (ABPM) Extension Study
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.
- Conditions
- Hypogonadism, Male
- Being tested
- SOV2012-F1
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOV2012-F1Drug
Oral preparation of testosterone undecanoate (TU). Strengths of 100 mg TU, 150 mg TU and 200 mg TU
| Study group | Role | What they receive |
|---|---|---|
| SOV2012-F1-treated | Experimental | 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. Receives: Drug: SOV2012-F1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 120 days
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.
Measured: 90 days
Secondary outcomes (8)
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).
Measured: 120 and 180 days
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).
Measured: 120 and 180 days
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.
Measured: 120 and 180 days
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.
Measured: 120 and 180 days
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.
Measured: 120 and 180 days
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.
Measured: 120 and 180 days
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.
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start18 Sep 2018
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Alistair Smith, MB, ChB, Study director, Syneos HealthOm Dhingra, PhD, Study chair, Marius Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467697
- Sponsor's protocol ID
- MRS-TU-2019EXT
- Status last verified
- Jun 2024
- First submitted
- 1 Jul 2020
- Last updated
- 28 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernstein JS, Dhingra OP. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Ther Adv Urol. 2024 Apr 10;16:17562872241241864. doi: 10.1177/17562872241241864. eCollection 2024 Jan-Dec.
PubMed 38606384
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Month, Open Label, Ambulatory Blood Pressure Monitoring (ABPM) Extension Study
- ClinicalTrials.gov ID
- NCT04467697
- Acronym / sponsor ID
- MRS-TU-2019EXT
- Conditions
- Hypogonadism, Male
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Marius PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOV2012-F1-treated | Experimental | Drug: SOV2012-F1Patients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Completion of MRS-TU-2019 Day 365/ End of Treatment
Key exclusion criteria (53 listed)
- Upper arm circumference > 45 cm.
- Long distance driving or planned driving trip (> 60 mins duration where the subject is doing the driving) during period of wearing ABPM cuff.
- Expected / known forthcoming change to antihypertensive medication(s) during the MRS-TU-2019 EXT extension study.
- Cardiac arrhythmias that, in the opinion of the investigator, interfere with the ability of the ABPM recorder to obtain reliable measurements.
- Use of T implantable pellets since completion of Day 365/EOT visit in MRS-TU- 2019.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOV2012-F1Oral preparation of testosterone undecanoate (TU). Strengths of 100 mg TU, 150 mg TU and 200 mg TU | Drug | SOV2012-F1-treated |
Primary outcome
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment
Time frame: 120 days
Change from baseline in 24-hour Ambulatory Systolic Blood Pressure (sBP) after approximately 120 days treatment (Mixed Model Repeated Measures analysis).
Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration
Time frame: 90 days
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.
8 secondary outcomes
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 180 Days Treatment.
Time frame: 120 and 180 days
Change From Baseline in 24-hour Average Ambulatory Diastolic Blood Pressure (dBP) After 120 Days and 180 Days of SOV2012-F1 Treatment.
Time frame: 120 and 180 days
Change From Baseline in 24-hour Average Ambulatory Heart Rate After 120 Days and 180 Days of Treatment.
Time frame: 120 and 180 days
Observed and Change From Baseline in Ambulatory Half Hourly Systolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
Time frame: 120 and 180 days
Observed and Change From Baseline in Ambulatory Half Hourly Diastolic Blood Pressure, After 120 Days and After 180 Days of SOV2012-F1 Treatment.
Time frame: 120 and 180 days
Observed and Change From Baseline in Ambulatory Half Hourly Heart Rate Measurement, After 120 Days and After 180 Days (±3) of SOV2012-F1 Treatment.
Time frame: 120 and 180 days
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
Time frame: 90 days
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
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38606384Bernstein JS, Dhingra OP. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Ther Adv Urol. 2024 Apr 10;16:17562872241241864. doi: 10.1177/17562872241241864. eCollection 2024 Jan-Dec.
- MRS-TU-2019 protocol, ClinicalTrials.gov ID: NCT03198728Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alistair Smith, MB, ChB study director
Syneos Health
Om Dhingra, PhD study chair
Marius Pharmaceuticals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SOV2012-F1 in people with Hypogonadism, Male, run by Marius Pharmaceuticals at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in 24-hour Average Ambulatory Systolic Blood Pressure After 120 Days Treatment (time frame: 120 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.