Hypogonadism, MalePhase 3NCT03198728
Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
A Phase 3 study testing SOV2012-F1 and AndroGel in people with Hypogonadism, Male, run by Marius Pharmaceuticals at 36 sites in United States.
Trial summary
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. 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 and AndroGel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 36 sitesUnited States
- Study dates
- 5 Jul 2017to 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
- 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%
Show all 11Show fewer
- BP < 150/90 mm Hg
- 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.
Who cannot join
- Serum PSA > 2.5 ng/ml and/or abnormal prostate gland on palpation, eg, 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.
- 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 (eg, 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 (eg, 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.
Show all 34Show fewer
- 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, bowel resection, or any surgical procedure 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, ie, 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/1.73m2 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 and 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.
- For adrenocorticotropic hormone (ACTH) stimulation substudy only: Primary or secondary adrenal insufficiency.
- For Bioanalytical Sample Stability Substudy only: subjects with a hemoglobin less than 13 g/dL at most recent assessment* [should be excluded].
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Primary Care Research Group
Atlanta, Georgia, 30312
South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of SE Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Central Research Associates, Inc.
Birmingham, Alabama, 35205
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
Men's Health Boston
Chestnut Hill, Massachusetts, 02467
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
Aventiv Research, Inc.
Columbus, Ohio, 43213
Rapha Institute For Clinical Research
Fayetteville, North Carolina, 28314
Accumed Research Associates
Garden City, New York, 11530
Centex Studies, Inc.
Houston, Texas, 77058
Pioneer Research Solutions, Inc.
Houston, Texas, 77099
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223
Health Awareness, Inc.
Jupiter, Florida, 33458
Centex Studies, Inc.
Lake Charles, Louisiana, 70601
Meridien Research
Lakeland, Florida, 33805
Palm Research Center, Inc.
Las Vegas, Nevada, 89148
Central Kentucky Research Associates
Lexington, Kentucky, 40509
Advanced Clinical Research
Meridian, Idaho, 83642
My Community Research Center
Miami, Florida, 33155
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Manhattan Medical Research Practice, PLLC
New York, New York, 10016
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
Mid-Columbia Research
Richland, Washington, 99352
National Clinical Research, Inc.
Richmond, Virginia, 23294
San Diego Sexual Medicine
San Diego, California, 92120
Meridien Research
St. Petersburg, Florida, 33709
Quality of Life Medical and Research Centers, LLC
Tucson, Arizona, 85712
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)
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.
Read the detailed description
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.
- Conditions
- Hypogonadism, Male
- Being tested
- SOV2012-F1, AndroGel
- 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)
AndroGelDrug
topical testosterone gel 1.62%
| Study group | Role | What they receive |
|---|---|---|
| SOV2012-F1-treated | Experimental | 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. Receives: Drug: SOV2012-F1 |
| Andro-Gel™ treated | Active comparator | 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. Receives: Drug: AndroGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (1)
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.
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 posted26 Jun 2017
- Study start5 Jul 2017
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Alastair Smith, MB, ChB, Study director, Syneos HealthOm Dhingra, PhD, Study chair, Marius Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198728
- Sponsor's protocol ID
- MRS-TU-2019
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2017
- Last updated
- 28 Jun 2023
- 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 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)
- ClinicalTrials.gov ID
- NCT03198728
- Acronym / sponsor ID
- MRS-TU-2019
- Conditions
- Hypogonadism, Male
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Marius PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOV2012-F1-treated | Experimental | Drug: SOV2012-F1200 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. |
| Andro-Gel™ treated | Active comparator | Drug: AndroGel100 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (34 listed)
- Serum PSA > 2.5 ng/ml and/or abnormal prostate gland on palpation, eg, 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.
- 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 (eg, 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 (eg, 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.
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) | Drug | SOV2012-F1-treated |
| AndroGeltopical testosterone gel 1.62% | Drug | Andro-Gel™ treated |
Primary outcome
Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1.
Time frame: 90 days
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.
1 secondary outcome
Percentages of Participants in Each Category for Maximum Plasma Concentration
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 2023.
- 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-2019EXT studyLink provided by the sponsor.
- Effects of Oral Testosterone Undecanoate (Kyzatrex) Versus Testosterone Gel (Androgel) on Long-Term (to 12 months) Blood Pressure LevelsLink 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.
Alastair Smith, MB, ChB study director
Syneos Health
Om Dhingra, PhD study chair
Marius Pharmaceuticals
36 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 and AndroGel in people with Hypogonadism, Male, run by Marius Pharmaceuticals at 36 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 11 inclusion and 34 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 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 2023). 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?
Percentage of Male Hypogonadal Subjects With Average NaF/EDTA Plasma Total Testosterone (T Cavg) Within the Normal Range Using Oral SOV2012-F1. (time frame: 90 days). 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 NCT03198728, 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 2023.