Hypogonadism, MalePhase 3NCT03868059
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
A Phase 3 study testing LPCN 1021 in people with Hypogonadism, Male, run by Lipocine Inc. at 16 sites in United States.
Trial summary
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- LPCN 1021
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 16 sitesUnited States
- Study dates
- 30 Apr 2018to 21 Feb 2019
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
- Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
- Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
- Serum total T below lab normal range (300 ng/dL) based on two consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy, if required.
- Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.
- Judged to be in good general health as determined by the investigator at screening.
Who cannot join
- History of significant sensitivity or allergy to androgens, or product excipients.
- Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
- Hemoglobin < 11.5 g/dL or > 16.5 g/dL
- Hematocrit < 35% or > 54%
- Serum transaminases > 2.5 times upper limit of normal
- Serum bilirubin > 2.0 mg/dL
Show all 29Show fewer
- Creatinine > 2.0 mg/dL
- PSA > 4 ng/mL
- Prolactin > 17.7 ng/mL.
- Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
- Subjects with screening systolic BP or diastolic BP above 160 mmHg or 100 mmHg, respectively.
- Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
- History of seizures or convulsions occurring after age 5, including alcohol or drug withdrawal seizures.
- History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
- Known tolerability issues with ABPM devices.
- History of stroke, myocardial infarction, transient ischemic attack, or acute coronary syndrome within the past 5 years.
- History of long QT syndrome (or QTcB > 450) or unexplained sudden death (including cardiac death) or history of long QT syndrome in a first degree relative (parent, sibling, or child).
- Subjects who are not on stable dose of current medication (no changes in medication in the last 3 months).
- History of current or suspected prostate or breast cancer.
- History of untreated obstructive sleep apnea or not compliant with sleep apnea treatment.
- Active alcohol or any drug substance abuse, or history of abuse that will interfere with the subject's ability to participate in the study in the judgement of the investigator.
- Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study. A list of prohibited medications is provided in Appendix C.
- Use of any investigational drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval.
- Receipt of any investigational drug by injection within 30 days or 10 half-lives (whichever is longer) prior to study drug administration without principal investigator and/or sponsor approval.
- Subject who is not willing to use adequate contraception for the duration of the study.
- Any contraindications to a MRI scan (i.e. subjects with non-removable ferromagnetic implants, pacemakers, aneurysm clips or other foreign bodies), and/or subjects with claustrophobic symptoms and/or inability to fit into an MRI scanner.
- Inability to understand and provide written informed consent for the study.
- Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive LPCN 1021 (exact reason should be specified by the investigator).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
South Florida Medical Research
Aventura, Florida, 33180
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Aventiv Research, Inc.
Columbus, Ohio, 43213
Clinical Research of South Florida
Coral Gables, Florida, 33134
Prestige Clinical Research
Franklin, Ohio, 45005
AccuMed Research Associates
Garden City, New York, 11530
Neostart Corporation dba AGA Clinical Trials
Hialeah, Florida, 33012
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Manhattan Medical Research Practice PLLC
New York, New York, 10016
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Rainier Clinical Research Center
Renton, Washington, 98057
Regional Urology
Shreveport, Louisiana, 71106
Granger Medical Clinic
West Valley City, Utah, 84096
About this study
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.
Read the detailed description
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.
The study is comprised of six scheduled visits: Visit 1 and 2 are for screening, Visit 3 is to assess subject's baseline BP and pulse rate (PR) via ABPM. Visit 4 is to enroll subjects, and to provide subjects with study medication for the start of dosing. Visit 5 is to assess subject's post-treatment BP and PR via ABPM. Visit 6 is to perform exit visit procedures.
- Conditions
- Hypogonadism, Male
- Being tested
- LPCN 1021
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPCN 1021Drug
Also called TLANDO
LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
| Study group | Role | What they receive |
|---|---|---|
| LPCN 1021 | Experimental | LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), Receives: Drug: LPCN 1021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
Measured: Baseline to end of study (approximately 4 months).
Secondary outcomes (17)
Change in ABPM-measured Average Daytime SBP
Change in average daytime SBP as measured by ABPM from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime SBP
Change in average nighttime SBP as measured by ABPM from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)
Change in average 24-hour DBP as measured by ABPM from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Daytime DBP
Change in average daytime DBP as measured by ABPM from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime DBP
Change in average nighttime DBP as measured by ABPM from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average 24-hour Pulse Rate (PR)
Change in average 24-hour pulse rate as measured by ABPM from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Daytime PR
Change in average daytime pulse rate as measured by ABPM from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime PR
Change in average nighttime pulse rate as measured by ABPM from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in Morning SBP Measured in Triplicate at the Clinic
Change in morning systolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in Morning DBP Measured in Triplicate at the Clinic
Change in morning diastolic blood pressure measured in triplicate at the clinic from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in Morning PR Measured in Triplicate at the Clinic
Change in morning pulse rate measured in triplicate at the clinic from Visit 3 to Visit 5
Measured: Baseline to End of Study (approximately 4 months)
Change in Patient Reported Sexual Distress
Change in patient reported sexual distress from visit 3 to Visit 5 Female Sexual Distress Scale - Revised, Item 13 Possible scores range from 0 (better) to 4 (worse)
Measured: Baseline to End of Study (approximately 4 months)
Change in Patient Reported Sexual Desire
Change in patient reported sexual desire from visit 3 to Visit 5 Psychosexual Daily Questionnaire Possible scores range from 0 (worse) to 5 (better)
Measured: Baseline to End of Study (approximately 4 months)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥5%
Measured: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥5%
Measured: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Interim Analysis (MRI-2) in subjects with a baseline MRI-PDFF of ≥10%
Measured: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%
Percent Relative Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) from Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) in subjects with a baseline MRI-PDFF of ≥10%
Measured: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start30 Apr 2018
- Primary completion19 Feb 2019
- Study completion21 Feb 2019
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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipocine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Delconte, MD, Study director, Lipocine Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868059
- Sponsor's protocol ID
- LPCN 1021-18-001
- Status last verified
- May 2021
- First submitted
- 21 Feb 2019
- Last updated
- 10 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
White WB, Dobs A, Carson C, DelConte A, Khera M, Miner M, Shahid M, Kim K, Chidambaram N. Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure in Hypogonadal Men. J Cardiovasc Pharmacol Ther. 2021 Nov;26(6):630-637. doi: 10.1177/10742484211027394. Epub 2021 Jun 30.
PubMed 34191621
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
- ClinicalTrials.gov ID
- NCT03868059
- Acronym / sponsor ID
- LPCN 1021-18-001
- Conditions
- Hypogonadism, Male
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Lipocine Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Posted 10 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.
Detailed description
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.
The study is comprised of six scheduled visits: Visit 1 and 2 are for screening, Visit 3 is to assess subject's baseline BP and pulse rate (PR) via ABPM. Visit 4 is to enroll subjects, and to provide subjects with study medication for the start of dosing. Visit 5 is to assess subject's post-treatment BP and PR via ABPM. Visit 6 is to perform exit visit procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPCN 1021 | Experimental | Drug: LPCN 1021LPCN 1021 at a 225 mg dose taken twice daily (total daily dose of 450 mg taken as 225 mg in the morning and 225 mg in the evening), |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
- Male between 18 and 80 years of age, inclusive, with documented onset of hypogonadism prior to age 65.
- Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
- Serum total T below lab normal range (300 ng/dL) based on two consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy, if required.
- Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.
Key exclusion criteria (29 listed)
- History of significant sensitivity or allergy to androgens, or product excipients.
- Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
- Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
- Subjects with screening systolic BP or diastolic BP above 160 mmHg or 100 mmHg, respectively.
- Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
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 |
|---|---|---|
| LPCN 1021Also: TLANDOLPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule. | Drug | LPCN 1021 |
Primary outcome
Change in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP)
Time frame: Baseline to end of study (approximately 4 months).
Change in average systolic blood pressure as measured by ambulatory blood pressure monitoring (ABPM) from Visit 3 (Baseline) to Visit 5 (End of Study)
17 secondary outcomes
Change in ABPM-measured Average Daytime SBP
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime SBP
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average 24-hour Diastolic Blood Pressure (DBP)
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Daytime DBP
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime DBP
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average 24-hour Pulse Rate (PR)
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Daytime PR
Time frame: Baseline to End of Study (approximately 4 months)
Change in ABPM-measured Average Nighttime PR
Time frame: Baseline to End of Study (approximately 4 months)
Change in Morning SBP Measured in Triplicate at the Clinic
Time frame: Baseline to End of Study (approximately 4 months)
Change in Morning DBP Measured in Triplicate at the Clinic
Time frame: Baseline to End of Study (approximately 4 months)
Change in Morning PR Measured in Triplicate at the Clinic
Time frame: Baseline to End of Study (approximately 4 months)
Change in Patient Reported Sexual Distress
Time frame: Baseline to End of Study (approximately 4 months)
Change in Patient Reported Sexual Desire
Time frame: Baseline to End of Study (approximately 4 months)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥5%
Time frame: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥5%
Time frame: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Interim Analysis (MRI-2)- Subgroup: MRI-PDFF of ≥10%
Time frame: Baseline (MRI-1) to Interim Analysis (MRI-2) (Approximately 8 Weeks)
Percent Relative Change in MRI-PDFF From Baseline (MRI-1) to Post-Treatment Analysis (MRI-3)- Subgroup: MRI-PDFF of ≥10%
Time frame: Baseline (MRI-1) to Post-Treatment Analysis (MRI-3) (Approximately 16 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34191621White WB, Dobs A, Carson C, DelConte A, Khera M, Miner M, Shahid M, Kim K, Chidambaram N. Effects of a Novel Oral Testosterone Undecanoate on Ambulatory Blood Pressure in Hypogonadal Men. J Cardiovasc Pharmacol Ther. 2021 Nov;26(6):630-637. doi: 10.1177/10742484211027394. Epub 2021 Jun 30.
- 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.
Anthony Delconte, MD study director
Lipocine Inc.
16 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 LPCN 1021 in people with Hypogonadism, Male, run by Lipocine Inc. at 16 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 6 inclusion and 29 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 10 Jun 2021). 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 in Ambulatory Blood Pressure Monitoring (ABPM)-Measured Average 24-hour Systolic Blood Pressure (SBP) (time frame: Baseline to end of study (approximately 4 months).). 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 NCT03868059, 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 10 Jun 2021.