ContraceptionPhase 1NCT04682353

A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age

A Phase 1 study testing TV-46046 and Depo-subQ Provera in people with Contraception, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception
What is being tested?: TV-46046 and Depo-subQ Provera
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 3 sitesin 2 countries
Study dates: 14 Dec 2020to 12 Jan 2023
Phase: Phase 1
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 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

has regular menstrual cycle (21 to 35 days)
has a low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using nonhormonal intrauterine device (IUD), or consistently using barrier methods of contraception)
had a normal mammogram within the last year, if 40 years of age or older
NOTE- Additional criteria apply, please contact the investigator for more information.

Who cannot join

has multiple risk factors for cardiovascular disease (eg, smoking, obesity, hypertension, known low HDL, high LDL, or high triglyceride levels)
has current or history of ischemic heart disease
has active thrombophlebitis, current or past history of thromboembolic disorders, cerebral vascular disease or stroke
has systemic lupus erythematosus
has rheumatoid arthritis on immunosuppressive therapy
has unexplained vaginal bleeding

Show all 25Show fewer

has diabetes
has strong family history of breast cancer (defined as one or more first degree relatives with breast cancer, breast cancer occurring before menopause in three or more family members, regardless of degree of relationship, and any male family member with breast cancer)
has current or history of breast cancer, or undiagnosed mass detected by breast exam
has current or history of cervical cancer
has cirrhosis or liver tumors
has known osteoporosis or osteopenia
has history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt, except short-lived situational depression that did not require medication and has not recurred in last five years
used MPA-containing injectable products in the past 12 months
used a combined injectable contraceptive in the past 6 months
used any of the following medications within 1 month prior to enrollment:
any investigational drug
oral contraceptives, contraceptive ring or patch
levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
is participating in another clinical trial
is pregnant
desires to become pregnant in subsequent 24 months
has been pregnant in last 3 months
is currently lactating
NOTE- Additional criteria apply, please contact the investigator for more information.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Teva Investigational Site 14002
Cypress, California, 90630
Teva Investigational Site 14003
San Antonio, Texas, 78209

Other trials in United States

Dominican Republic1 site

Teva Investigational Site 18001
Santo Domingo, 99999

Other trials in Dominican Republic

About this study

Official title: A Randomized, Dose-range Finding Study to Evaluate Pharmacokinetics of Medroxyprogesterone Acetate Following a Single Subcutaneous Administration of TV-46046 in Healthy Women of Reproductive Age

The secondary objectives of the study are to evaluate and compare the safety, local tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants.

The total duration of the study for each participant is expected to be up to 19.5 months.

Conditions: Contraception
Being tested: TV-46046, Depo-subQ Provera
Keywords: Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TV-46046Drug
SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)
Depo-subQ ProveraDrug
SC injection of 104 mg/0.65 mL

Study groups in NCT04682353
Study group	Role	What they receive
Group 1 - 120 mg/0.4 mL	Experimental	Not described Receives: Drug: TV-46046
Group 2 - 180 mg/0.6 mL	Experimental	Not described Receives: Drug: TV-46046
Group 3 - 240 mg/0.8 mL	Experimental	Not described Receives: Drug: TV-46046
Group 4 - 104 mg/0.65 mL	Active comparator	Not described Receives: Drug: Depo-subQ Provera

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)
Measured: Day 0 to Day 365
Time to Reach Cmax (Tmax) of MPA
Measured: Day 0 to Day 365
Serum MPA Concentration at Day 91 (C91)
Measured: Day 91
Serum MPA Concentration at Day 182 (C182)
Measured: Day 182
Serum MPA Concentration at Day 210 (C210)
Measured: Day 210
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
Measured: Day 0 to Day 182
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
Measured: Day 0 to Day 210
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA
Measured: Day 0 to Day 365
Apparent Terminal Half-life (t½) of MPA
Measured: Day 0 to Day 365

Secondary outcomes (15)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 0 up to Week 78
Number of Participants With at Least 1 Concomitant Medication Use During Treatment
Concomitant medications included acetic acid derivatives and substances, aminoalkyl ethers, anilides, calcium compounds, other viral vaccines, and propionic acid derivatives etc.
Measured: Day 0 up to Week 78
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs examination included blood pressure, respiration rate, pulse, and body temperature.
Measured: Day 0 to Day 365
Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
Measured: Day 7 and Weeks 13, 26, and 52
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
Number of participants with overall opinion of vaginal bleeding pattern as acceptable or not acceptable has been reported.
Measured: Weeks 13, 26, and 52
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
The PHQ-9 is a participant-rated depressive symptom severity scale to monitor severity over time for newly diagnosed participants or participants in current treatment for depression. Scoring was based on participants' responses to each of the 9 questions, as follows: 0=not at all; 1=several days; 2=more than half the days; and 3=nearly every day. The PHQ-9 total score was calculated as the sum of the 9 individual item scores. The PHQ-9 total score was categorized as follows: 0 = no depression, 1 to 4=minimal depression, 5 to 9=mild depression, 10 to 14=moderate depression, 15 to 19=moderately severe depression; and 20 to 27=severe depression. Higher scores indicate more severe depression.
Measured: Baseline, Weeks 4, 13, 26, and 52
Number of Participants With Clinically Significant Changes in Liver Function Tests
Measured: Day 0 to Day 365
Estradiol Concentrations
Measured: Baseline, Weeks 4, 13, 26, 30, and 52
Number of Participants With No Ovulation in 12 Months
Ovulation was defined as one or more progesterone measurements ≥ 4.7 ng/mL in Weeks 48, 49, 50, 51 or 52.
Measured: 12 months
Number of Participants With 1 or More Injection Site Reactions (ISRs)
The ISRs included erythema, swelling, pruritus, bleeding, tenderness, bruising, hypopigmentation, atrophy, and injection site pain.
Measured: Day 0 to Day 365
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Measured: Weeks 26 and 52
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Measured: Weeks 26 and 52
Number of Participants With Responses to the Acceptability Question (If You Were at Risk for Pregnancy, Would You Use This Method of Contraception Outside of This Study?)
Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Measured: Weeks 26 and 52
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Acceptability questions include likes and dislikes of the method and willingness to use the product in the future.
Measured: Weeks 26 and 52
Progesterone Concentration
Measured: Weeks 48, 49, 50, 51, and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 202012 Jan 2023

First posted23 Dec 2020
Study start14 Dec 2020
Primary completion11 Jul 2022
Study completion12 Jan 2023

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.
Other trials for ContraceptionStudies 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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04682353
Sponsor's protocol ID: TV46046-WH-10159
Status last verified: Jul 2023
First submitted: 4 Dec 2020
Last updated: 26 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Upon primary clinical trial manuscript publication, researchers may request access to underlying study data. Each accepted article must be accompanied by a Data Availability Statement that describes where any primary data, associated metadata, original software, and any additional relevant materials necessary to understand, assess, and replicate the reported study findings in totality can be found. Underlying study data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Please email manuscript primary author to make your request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Dose-range Finding Study to Evaluate Pharmacokinetics of Medroxyprogesterone Acetate Following a Single Subcutaneous Administration of TV-46046 in Healthy Women of Reproductive Age
ClinicalTrials.gov ID: NCT04682353
Acronym / sponsor ID: TV46046-WH-10159
Conditions: Contraception
Keywords: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Collaborators: FHI 360
Study start: 14 Dec 2020 (actual)
Primary completion: 11 Jul 2022 (actual)
Study completion: 12 Jan 2023 (actual)
First posted: 23 Dec 2020 (actual)
Results: Posted 26 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The total duration of the study for each participant is expected to be up to 19.5 months.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1 - 120 mg/0.4 mL	Experimental	Drug: TV-46046
Group 2 - 180 mg/0.6 mL	Experimental	Drug: TV-46046
Group 3 - 240 mg/0.8 mL	Experimental	Drug: TV-46046
Group 4 - 104 mg/0.65 mL	Active comparator	Drug: Depo-subQ Provera

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

has regular menstrual cycle (21 to 35 days)
has a low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, abstinent, in monogamous relationship with vasectomized partner, using nonhormonal intrauterine device (IUD), or consistently using barrier methods of contraception)
had a normal mammogram within the last year, if 40 years of age or older
NOTE- Additional criteria apply, please contact the investigator for more information.

Key exclusion criteria (25 listed)

has multiple risk factors for cardiovascular disease (eg, smoking, obesity, hypertension, known low HDL, high LDL, or high triglyceride levels)
has current or history of ischemic heart disease
has active thrombophlebitis, current or past history of thromboembolic disorders, cerebral vascular disease or stroke
has systemic lupus erythematosus
has rheumatoid arthritis on immunosuppressive therapy

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
TV-46046SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)	Drug	Group 1 - 120 mg/0.4 mL, Group 2 - 180 mg/0.6 mL, Group 3 - 240 mg/0.8 mL
Depo-subQ ProveraSC injection of 104 mg/0.65 mL	Drug	Group 4 - 104 mg/0.65 mL

Primary outcome

Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)
Time frame: Day 0 to Day 365
Time to Reach Cmax (Tmax) of MPA
Time frame: Day 0 to Day 365
Serum MPA Concentration at Day 91 (C91)
Time frame: Day 91
Serum MPA Concentration at Day 182 (C182)
Time frame: Day 182
Serum MPA Concentration at Day 210 (C210)
Time frame: Day 210
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
Time frame: Day 0 to Day 182
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
Time frame: Day 0 to Day 210
Area Under the Serum Drug Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MPA
Time frame: Day 0 to Day 365
Apparent Terminal Half-life (t½) of MPA
Time frame: Day 0 to Day 365

15 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 0 up to Week 78
Number of Participants With at Least 1 Concomitant Medication Use During Treatment
Time frame: Day 0 up to Week 78
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Day 0 to Day 365
Change From Baseline in Body Weight at Day 7 and Weeks 13, 26, and 52
Time frame: Day 7 and Weeks 13, 26, and 52
Number of Participants With Overall Opinion of Vaginal Bleeding Pattern
Time frame: Weeks 13, 26, and 52
Number of Participants With Patient Health Questionnaire (PHQ-9) Mood Scores
Time frame: Baseline, Weeks 4, 13, 26, and 52
Number of Participants With Clinically Significant Changes in Liver Function Tests
Time frame: Day 0 to Day 365
Estradiol Concentrations
Time frame: Baseline, Weeks 4, 13, 26, 30, and 52
Number of Participants With No Ovulation in 12 Months
Time frame: 12 months
Number of Participants With 1 or More Injection Site Reactions (ISRs)
Time frame: Day 0 to Day 365
Number of Participants With Responses to the Acceptability Question (What do You Like About the Method?)
Time frame: Weeks 26 and 52
Number of Participants With Responses to the Acceptability Question (What do You Not Like About the Method?)
Time frame: Weeks 26 and 52
Number of Participants With Responses to the Acceptability Question (If You Were at Risk for Pregnancy, Would You Use This Method of Contraception Outside of This Study?)
Time frame: Weeks 26 and 52
Number of Participants With Responses to the Acceptability Question (If You Had a Choice, Which Injectable Contraceptive Method Would You Prefer?)
Time frame: Weeks 26 and 52
Progesterone Concentration
Time frame: Weeks 48, 49, 50, 51, and 52

Results and safety

Results posted to the registry on 26 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TV46046 Dose A	16	16
TV46046 Dose B	15	13
TV46046 Dose C	14	14
Depo-subQ Provera	15	14

Primary outcome: Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA)

Time frame: Day 0 to Day 365. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms (ng)/ milliliter (mL)

Measure	TV46046 Dose A n = 16	TV46046 Dose B n = 15	TV46046 Dose C n = 14	Depo-subQ Provera n = 14
Value	0.940 (41.187)	1.180 (39.076)	1.750 (41.407)	0.963 (47.672)

TV46046 Dose A vs Depo-subQ Provera: Geometric Mean Ratio: 0.976 (90% CI 0.748 to 1.274)
TV46046 Dose B vs Depo-subQ Provera: Geometric Mean Ratio: 1.226 (90% CI 0.940 to 1.598)
TV46046 Dose C vs Depo-subQ Provera: Geometric Mean Ratio: 1.817 (90% CI 1.380 to 2.392)

Population analysed: Pharmacokinetic (PK) analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen.

Primary outcome: Time to Reach Cmax (Tmax) of MPA

Time frame: Day 0 to Day 365. Median (Full Range). Unit: days

Measure	TV46046 Dose A n = 16	TV46046 Dose B n = 15	TV46046 Dose C n = 14	Depo-subQ Provera n = 14
Value	17.0 (1.0 to 105.0)	28.0 (1.0 to 71.0)	6.0 (2.0 to 336.0)	31.5 (1.0 to 105.0)

Population analysed: PK analysis set included all randomized participants who received an injection of study drug, excluding any participants who had a baseline MPA concentration that exceeded 5% of their individual Cmax, had an important protocol deviation that may affect interpretation of their MPA data, or failed to provide at least 1 evaluable post-treatment MPA specimen.

Primary outcome: Serum MPA Concentration at Day 91 (C91)

Time frame: Day 91. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	TV46046 Dose A n = 16	TV46046 Dose B n = 15	TV46046 Dose C n = 14	Depo-subQ Provera n = 14
Value	0.570 (36.802)	0.660 (49.360)	1.090 (40.151)	0.474 (37.765)

TV46046 Dose A vs Depo-subQ Provera: Geometric Mean Ratio: 1.202 (90% CI 0.960 to 1.506)
TV46046 Dose B vs Depo-subQ Provera: Geometric Mean Ratio: 1.393 (90% CI 1.070 to 1.815)
TV46046 Dose C vs Depo-subQ Provera: Geometric Mean Ratio: 2.301 (90% CI 1.806 to 2.933)

Primary outcome: Serum MPA Concentration at Day 182 (C182)

Time frame: Day 182. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	TV46046 Dose A n = 16	TV46046 Dose B n = 13	TV46046 Dose C n = 13	Depo-subQ Provera n = 12
Value	0.201 (69.429)	0.279 (65.793)	0.443 (60.531)	0.118 (150.789)

TV46046 Dose A vs Depo-subQ Provera: Geometric Mean Ratio: 1.699 (90% CI 0.921 to 3.135)
TV46046 Dose B vs Depo-subQ Provera: Geometric Mean Ratio: 2.364 (90% CI 1.273 to 4.390)
TV46046 Dose C vs Depo-subQ Provera: Geometric Mean Ratio: 3.748 (90% CI 2.033 to 6.908)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 up to Week 78. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TV46046 Dose A	0 of 16 (0%)	11 of 16 (68.8%)	0 of 16
TV46046 Dose B	0 of 15 (0%)	10 of 15 (66.7%)	0 of 15
TV46046 Dose C	0 of 14 (0%)	8 of 14 (57.1%)	0 of 14
Depo-subQ Provera	1 of 15 (6.7%)	12 of 15 (80%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Upon primary clinical trial manuscript publication, researchers may request access to underlying study data. Each accepted article must be accompanied by a Data Availability Statement that describes where any primary data, associated metadata, original software, and any additional relevant materials necessary to understand, assess, and replicate the reported study findings in totality can be found. Underlying study data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Please email manuscript primary author to make your request.

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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.

Teva Medical Expert, MD study director

Teva Branded Pharmaceutical Products R&D, Inc.

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TV-46046 and Depo-subQ Provera in people with Contraception, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 sites in 2 countries.

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 4 inclusion and 25 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Dominican Republic. 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 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?

Yes. Results are posted in the registry (first posted 26 Feb 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?

Maximum Observed Serum Concentration (Cmax) of Medroxyprogesterone Acetate (MPA) (time frame: Day 0 to Day 365). The study lists 9 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 NCT04682353.

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 26 Feb 2024.