HypertensionPhase 1NCT04922424
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
A Phase 1 study testing Atorvastatin in people with Hypertension and Hyperlipidemias, run by Yale University at 1 site in United States.
Trial summary
Gender-identity differences are becoming increasingly diagnosed in the US and treatment with gender-affirming hormone therapy (GAHT) is associated with improved mental health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hyperlipidemias
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 31 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Two groups (n=10 each) of subjects will be recruited to complete this study: 1) trans men between 18 and 35 years; 2) cisgender women between 18 and 35 years (Controls). They will have a body mass index (BMI) 18-30 kg·m-2. Our subjects will be matched on BMI and IR, using hemoglobin A1c and Homeostatic Model Assessment of Insulin Resistance technique (HOMA-IR) in order to isolate testosterone effects from other co-morbidities that may impact BP, sympathetic activity or endothelial function. Subjects will have HbA1c of 4-5.9% and a HOMA-IR of 0.5-1.4 to be included in the study. Subjects who smoke, have diabetes, or BP>140/90 will be excluded. Subjects will not be taking medications during the study, including any insulin sensitizing or CV medications.
Who cannot join
- Subjects with the following histories or conditions will be excluded from the study:
- Gynecologic: a. current or past estrogen-dependent neoplasia, b. unexplained vaginal bleeding, c. history of uterine fibroids, d. current pregnancy, e. known or suspected breast or uterine cancer, f. partial or complete hysterectomy.
- Cardiac: a. myocardial infarction, ventricular tachycardia or fibrillation, b. angina, c. valvular disease (mitral insufficiency or stenosis, aortic insufficiency or stenosis), d. congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea, e. current arrhythmias, f. prosthetic valves.
- Pulmonary: a. current cigarette smokers, or pipe or cigar smokers, b. chronic obstructive pulmonary disease, c. adult asthma, d. dyspnea on exertion, e. current bronchitis, pneumonia, or tuberculosis, f. lung carcinoma, g. pulmonary embolus, h. deep vein thrombosis.
- Vascular: a. claudications or history of peripheral vascular disease, b. abdominal or thoracic aortic aneurysm, or repair of same, c. cerebral aneurysm, vascular malformations, d. hypertension, systolic or diastolic, or strong family history of hypertension.
- Gastrointestinal: a. GI malignancy, b. hepatitis or other liver disease, current, c. splenomegaly from any cause, d. Cholecystitis, e. current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative colitis, Crohn's disease, f. previous gastrointestinal surgery.
Show all 11Show fewer
- Infectious Disease: any ongoing intercurrent infection. Hematologic/Oncologic: a. receiving chemotherapy or radiation therapy, b. any metastatic malignancy, c. anemia (hematocrit < 35), d. thrombocytopenia or thrombocytosis, e. neutropenia, f. hematologic malignancy, g. bleeding dyscrasia.
- Neurologic: a. history of cerebral vascular accident with any neurologic sequels, b. uncontrolled seizures (e.g., more than 1 seizure/year), c. transient ischemic attacks, d. dementia, e. neurologic conditions producing dyscoordination, peripheral neuropathy, or myopathy.
- Endocrine: a. diabetes mellitus, b. any untreated endocrinopathy. Renal: a. chronic renal diseases, b. any history of renal disease or impairment, c. current urinary tract infection.
- Musculoskeletal: a. inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters), b. any history of pathologic fractures, including vertebral compression fractures.
- Pharmacologic: a. any illegal drug use, b. alcohol use greater than an average of 4 oz/day over 30 days, c. coumadin or heparin use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06519
About this study
Gender-identity differences are becoming increasingly diagnosed in the US and treatment with gender-affirming hormone therapy (GAHT) is associated with improved mental health outcomes. However, GAHT has been associated with cardiovascular risk in adult transgender patients, although mechanisms and treatments have not been explored. Understanding the cardiovascular effects and exploring the potential of a lipid sensitive statin as a potential treatment is important to optimizing safe treatment strategies for transgender men in mitigating this modifiable risk factor, and designing and implementing effective interventions.
Read the detailed description
In the US approximately 1.4 million men identify as transgender, a number that is likely to increase with greater recognition of this condition. Gender affirming hormone therapy (GAHT), which attempts to more align the physical appearance with the identified gender, is the primary medical intervention for transgender people and is recognized as medically necessary. GAHT has been associated with increased cardiovascular risk (increased blood pressure, dyslipidemia, and endothelial dysfunction) in transgender men receiving androgens, however little is known about the mechanisms for these changes and few interventions have been proposed. We hypothesize that the altered hormonal milieu is the major driver of increased cardiovascular risk in trans men, and the initiation of testosterone will have effects on lipid profiles, blood pressure and endothelial function. In addition, androgen exposure within the female vascular system is associated with sympathetic nervous system dysregulation. We propose this dysregulation is mediated through rapid dyslipidemia associated with GAHT in trans men receiving androgens. The first aim of this proposal is to test the hypothesis that testosterone treatment in trans men increases sympathetic activation, blood pressure and endothelial dysfunction. Recent studies have demonstrated that vascular endothelial cells are crucial to the pathogenesis of inflammatory disease. Thus, the cholesterol lowering effects of certain statins appear to be mediated, in part, by their action on the endothelium. Important to these studies, HMG-CoA reductase inhibitors (i.e. lipid dependent statins) not only lower LDL-C, but improve both central sympathetic and peripheral microvascular function. Therefore, our second aim is to test the hypothesis that lipid dependent statin therapy will decrease sympathetic activation and improve endothelial function in trans men taking GAHT indicating that the increased sympathetic activity and endothelial dysfunction are mediated by the increased LDL-C with androgens. Trans men undergoing GAHT and cisgender female controls will be examined twice: at baseline, and again following 30 days of treatment with the lipid dependent statin, atorvastatin, in a randomized cross over design. Using microneurography, measures of sympathetic nerve activity (SNA) in response to stressors will be quantified and analyzed within- and between groups and cardiovascular metrics including beat to beat blood pressure and conduit-level endothelial function will be assessed at baseline and with atorvastatin treatment. These novel and innovative studies will illuminate the sympathetic and vascular changes that accompany GAHT, and our atorvastatin intervention will provide insight into the mechanism for these changes as well as provide a method to reduce these risks in trans men undergoing GAHT. This is a critical gap in our knowledge; once these early changes can be identified and quantified, subsequent studies can track these changes over longer trajectories of treatment.
- Conditions
- Hypertension, Hyperlipidemias
- Being tested
- Atorvastatin, placebo
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Subjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first. We will include 30 days of washout between treatments to minimize any potential carryover effects.
placeboOther
Subjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first. We will include 30 days of washout between treatments to minimize any potential
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin | Experimental | We are testing that the lipid sensitive statin, atorvastatin treatment will reduce low density lipoprotein cholesterone, sympathetic nerve activity, increase endothelium-dependent vasodilation and improve autonomic function in trans men, while having little impact on cis women. Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | We are testing that the placebo will have little effect on low density lipoprotein cholesterone, sympathetic nerve activity, endothelium-dependent vasodilation, autonomic function in trans men or cis women. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow mediated vasodilation (FMD)
FMD measures endothelial function, measured in % change from baseline arterial diameter after release following a short period of occlusion occlusion. The % change in diameter reflects the ability of the vessel to dilate in response to sheer stress induced by the flow following the release of occlusion. This reflects the function of the endothelium, or release of nitric oxide.
Measured: 30 minutes
Muscle Sympathetic Nerve activity (MSNA)
measured using microneurography and expressed in bursts/min or bursts/100 heart beats
Measured: 2 hours
Cardiovagal baroreflex sensitivity (BRS)
This is determined as a function of change in R-R interval (from EKG) over systolic blood pressure during rest and regular breathing. Expressed in Units.
Measured: 2 hours
Mental Stress Test
While measuring sympathetic nervous system activity (SNS) with microneurography, we ask the subject to count backwards from 200 by 7. This increases SNS. Measured in bursts/min or burst/100 heart beats
Measured: 10 minutes
Voluntary Breath-Hold
While measuring sympathetic nervous system activity (SNS) with microneurography, we ask the subject to hold breath as long as possible without straining. The subject does this twice, with a break in between. This increases SNS. Measured in bursts/min or burst/100 heart beats
Measured: 10 minutes
Systolic Blood Pressure
SBP, measured in mmHg
Measured: 2 hours
Diastolic Blood Pressure
DBP, measured in mmHg
Measured: 2 hours
serum total cholesterol
Measured in ng/dl. Elevated total cholesterol can indicate dyslipidemia.
Measured: 5 minutes
serum low density lipoprotein (LDL)-C
Measured in ng/dl. Elevated LDL-C can indicate dyslipidemia
Measured: 5 minutes
serum high density lipoprotein (HDL-C)
Measured in ng/dl. Low HDL-C can indicate dyslipidemia
Measured: 5 minutes
plasma endothelin-1, (S[ET-1])
endothelial health, increased ET-1 levels in the blood indicate damage to the endothelium
Measured: 5 minutes
Secondary outcomes (6)
plasma Catecholamines
Measure of norepinephrine in pg/ml is a measure of whole body sympathetic nervous system outflow
Measured: 5 minutes
serum estradiol (S[E2])
estrogen is measured in pg/ml. This should be suppressed in our trans subjects, and low in our cis subjects. In the latter, low estrogen should indicate the early follicular phase of the menstrual cycle.
Measured: 5 minutes
serum progesterone (S[P4])
progesterone is measured in pg/ml. This should be suppressed in our trans subjects, and low in our cis subjects. In the latter, low progesterone should indicate the early follicular or ovulatory phases of the menstrual cycle.
Measured: 5 minutes
serum sex hormone binding globulin (P[SHBG])
measured in pg/ml. This provides us with an indication of how much testosterone is free versus bound in the serum, and thus is available for biological function.
Measured: 5 minutes
serum testosterone
measured in pg/ml. This indicates the level of testosterone in our trans men showing they are receiving treatment. It should be high in our trans men and low in our cis women subjects.
Measured: 5 minutes
plasma creatinine
This is a measure of kidney function. Important for blood pressure regulation
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start30 Sep 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Baseline testing, then each condition (group) will receive atorvastatin or placebo, followed by washout. Then receive the other condition.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Stachenfeld, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922424
- Sponsor's protocol ID
- 2000030176
- Status last verified
- Oct 2022
- First submitted
- 4 Jun 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
- ClinicalTrials.gov ID
- NCT04922424
- Acronym / sponsor ID
- 2000030176
- Conditions
- Hypertension, Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gender-identity differences are becoming increasingly diagnosed in the US and treatment with gender-affirming hormone therapy (GAHT) is associated with improved mental health outcomes. However, GAHT has been associated with cardiovascular risk in adult transgender patients, although mechanisms and treatments have not been explored. Understanding the cardiovascular effects and exploring the potential of a lipid sensitive statin as a potential treatment is important to optimizing safe treatment strategies for transgender men in mitigating this modifiable risk factor, and designing and implementing effective interventions.
Detailed description
In the US approximately 1.4 million men identify as transgender, a number that is likely to increase with greater recognition of this condition. Gender affirming hormone therapy (GAHT), which attempts to more align the physical appearance with the identified gender, is the primary medical intervention for transgender people and is recognized as medically necessary. GAHT has been associated with increased cardiovascular risk (increased blood pressure, dyslipidemia, and endothelial dysfunction) in transgender men receiving androgens, however little is known about the mechanisms for these changes and few interventions have been proposed. We hypothesize that the altered hormonal milieu is the major driver of increased cardiovascular risk in trans men, and the initiation of testosterone will have effects on lipid profiles, blood pressure and endothelial function. In addition, androgen exposure within the female vascular system is associated with sympathetic nervous system dysregulation. We propose this dysregulation is mediated through rapid dyslipidemia associated with GAHT in trans men receiving androgens. The first aim of this proposal is to test the hypothesis that testosterone treatment in trans men increases sympathetic activation, blood pressure and endothelial dysfunction. Recent studies have demonstrated that vascular endothelial cells are crucial to the pathogenesis of inflammatory disease. Thus, the cholesterol lowering effects of certain statins appear to be mediated, in part, by their action on the endothelium. Important to these studies, HMG-CoA reductase inhibitors (i.e. lipid dependent statins) not only lower LDL-C, but improve both central sympathetic and peripheral microvascular function. Therefore, our second aim is to test the hypothesis that lipid dependent statin therapy will decrease sympathetic activation and improve endothelial function in trans men taking GAHT indicating that the increased sympathetic activity and endothelial dysfunction are mediated by the increased LDL-C with androgens. Trans men undergoing GAHT and cisgender female controls will be examined twice: at baseline, and again following 30 days of treatment with the lipid dependent statin, atorvastatin, in a randomized cross over design. Using microneurography, measures of sympathetic nerve activity (SNA) in response to stressors will be quantified and analyzed within- and between groups and cardiovascular metrics including beat to beat blood pressure and conduit-level endothelial function will be assessed at baseline and with atorvastatin treatment. These novel and innovative studies will illuminate the sympathetic and vascular changes that accompany GAHT, and our atorvastatin intervention will provide insight into the mechanism for these changes as well as provide a method to reduce these risks in trans men undergoing GAHT. This is a critical gap in our knowledge; once these early changes can be identified and quantified, subsequent studies can track these changes over longer trajectories of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Baseline testing, then each condition (group) will receive atorvastatin or placebo, followed by washout. Then receive the other condition.
| Arm | Type | Receives |
|---|---|---|
| atorvastatin | Experimental | Drug: AtorvastatinWe are testing that the lipid sensitive statin, atorvastatin treatment will reduce low density lipoprotein cholesterone, sympathetic nerve activity, increase endothelium-dependent vasodilation and improve autonomic function in trans men, while having little impact on cis women. |
| Placebo | Placebo comparator | Other: placeboWe are testing that the placebo will have little effect on low density lipoprotein cholesterone, sympathetic nerve activity, endothelium-dependent vasodilation, autonomic function in trans men or cis women. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Two groups (n=10 each) of subjects will be recruited to complete this study: 1) trans men between 18 and 35 years; 2) cisgender women between 18 and 35 years (Controls). They will have a body mass index (BMI) 18-30 kg·m-2. Our subjects will be matched on BMI and IR, using hemoglobin A1c and Homeostatic Model Assessment of Insulin Resistance technique (HOMA-IR) in order to isolate testosterone effects from other co-morbidities that may impact BP, sympathetic activity or endothelial function. Subjects will have HbA1c of 4-5.9% and a HOMA-IR of 0.5-1.4 to be included in the study. Subjects who smoke, have diabetes, or BP>140/90 will be excluded. Subjects will not be taking medications during the study, including any insulin sensitizing or CV medications.
Key exclusion criteria (11 listed)
- Subjects with the following histories or conditions will be excluded from the study:
- Gynecologic: a. current or past estrogen-dependent neoplasia, b. unexplained vaginal bleeding, c. history of uterine fibroids, d. current pregnancy, e. known or suspected breast or uterine cancer, f. partial or complete hysterectomy.
- Cardiac: a. myocardial infarction, ventricular tachycardia or fibrillation, b. angina, c. valvular disease (mitral insufficiency or stenosis, aortic insufficiency or stenosis), d. congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea, e. current arrhythmias, f. prosthetic valves.
- Pulmonary: a. current cigarette smokers, or pipe or cigar smokers, b. chronic obstructive pulmonary disease, c. adult asthma, d. dyspnea on exertion, e. current bronchitis, pneumonia, or tuberculosis, f. lung carcinoma, g. pulmonary embolus, h. deep vein thrombosis.
- Vascular: a. claudications or history of peripheral vascular disease, b. abdominal or thoracic aortic aneurysm, or repair of same, c. cerebral aneurysm, vascular malformations, d. hypertension, systolic or diastolic, or strong family history of hypertension.
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 |
|---|---|---|
| AtorvastatinSubjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first. We will include 30 days of washout between treatments to minimize any potential carryover effects. | Drug | atorvastatin |
| placeboSubjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first. We will include 30 days of washout between treatments to minimize any potential | Other | Placebo |
Primary outcome
flow mediated vasodilation (FMD)
Time frame: 30 minutes
FMD measures endothelial function, measured in % change from baseline arterial diameter after release following a short period of occlusion occlusion. The % change in diameter reflects the ability of the vessel to dilate in response to sheer stress induced by the flow following the release of occlusion. This reflects the function of the endothelium, or release of nitric oxide.
Muscle Sympathetic Nerve activity (MSNA)
Time frame: 2 hours
measured using microneurography and expressed in bursts/min or bursts/100 heart beats
Cardiovagal baroreflex sensitivity (BRS)
Time frame: 2 hours
This is determined as a function of change in R-R interval (from EKG) over systolic blood pressure during rest and regular breathing. Expressed in Units.
Mental Stress Test
Time frame: 10 minutes
While measuring sympathetic nervous system activity (SNS) with microneurography, we ask the subject to count backwards from 200 by 7. This increases SNS. Measured in bursts/min or burst/100 heart beats
Voluntary Breath-Hold
Time frame: 10 minutes
While measuring sympathetic nervous system activity (SNS) with microneurography, we ask the subject to hold breath as long as possible without straining. The subject does this twice, with a break in between. This increases SNS. Measured in bursts/min or burst/100 heart beats
Systolic Blood Pressure
Time frame: 2 hours
SBP, measured in mmHg
Diastolic Blood Pressure
Time frame: 2 hours
DBP, measured in mmHg
serum total cholesterol
Time frame: 5 minutes
Measured in ng/dl. Elevated total cholesterol can indicate dyslipidemia.
serum low density lipoprotein (LDL)-C
Time frame: 5 minutes
Measured in ng/dl. Elevated LDL-C can indicate dyslipidemia
serum high density lipoprotein (HDL-C)
Time frame: 5 minutes
Measured in ng/dl. Low HDL-C can indicate dyslipidemia
plasma endothelin-1, (S[ET-1])
Time frame: 5 minutes
endothelial health, increased ET-1 levels in the blood indicate damage to the endothelium
6 secondary outcomes
plasma Catecholamines
Time frame: 5 minutes
serum estradiol (S[E2])
Time frame: 5 minutes
serum progesterone (S[P4])
Time frame: 5 minutes
serum sex hormone binding globulin (P[SHBG])
Time frame: 5 minutes
serum testosterone
Time frame: 5 minutes
plasma creatinine
Time frame: 5 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
Nina Stachenfeld principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin in people with Hypertension and Hyperlipidemias, run by Yale University at 1 site 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 11 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: withdrawn, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
flow mediated vasodilation (FMD) (time frame: 30 minutes). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2022.