Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenPhase 1NCT06219902
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
A Phase 1 study testing Elinzanetant (BAY3427080) and Zopiclone in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men and Hot Flashes, run by Bayer at 1 site in Canada.
Trial summary
Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes. Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes
- What is being tested?
- Elinzanetant (BAY3427080) and Zopiclone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2024to 15 Apr 2024
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females aged 40 to 65 years, inclusive, at signing of informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and electrocardiogram (ECG).
- Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).
- Participant possesses a valid driver's license and is an active driver. Drives a minimum of 8,000 kilometers per year for the previous 3 years.
Who cannot join
- Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.
- A history within 2 years of, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the participant's sleep.
- Abnormal finding in the physical examination, ECG, blood pressure, pulse rate or clinical laboratory results at Screening, that are considered clinically significant by the investigator.
- Use of any medication of dietary supplement which may affect central nervous system (CNS) function and may confound the pharmacodynamic assessments of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo- and Active-controlled, 4-period, Crossover Study to Investigate Effects of Elinzanetant on Simulated Driving Performance and Cognitive Function in Healthy Women
Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes.
Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.
Read more
The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.
Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.
The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.
For this, researchers will study participants' ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).
In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.
Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.
Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.
This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):
- dose A of elinzanetant and a zopiclone placebo
- dose B of elinzanetant and a zopiclone placebo
- zopiclone 7.5 milligrams (mg) and elinzanetant placebo
- elinzanetant placebo and zopiclone placebo
Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.
Participants will visit the study site:
- once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
- once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
- once, 2 to 3 days after their last treatment so the study doctors and their team can check on their health
During the study, the doctors and their study team will:
- check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
- check the participants' ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
- check the level of the study drugs in participants' blood
- ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment or not.
- Being tested
- Elinzanetant (BAY3427080), Placebo to elinzanetant, Zopiclone, Placebo to zopiclone
- Keywords
- Driving performance,, Cognitive function
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elinzanetant (BAY3427080)Drug
Oral administration of multiple doses of elinzanetant.
Placebo to elinzanetantDrug
Oral administration
ZopicloneDrug
Oral administration
Placebo to zopicloneDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequences A-C-D-B | Experimental | Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo). Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo to elinzanetant; Drug: Zopiclone; Drug: Placebo to zopiclone |
| Treatment sequences B-D-C-A | Experimental | Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo). Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo to elinzanetant; Drug: Zopiclone; Drug: Placebo to zopiclone |
| Treatment sequences C-B-A-D | Experimental | Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo). Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo to elinzanetant; Drug: Zopiclone; Drug: Placebo to zopiclone |
| Treatment sequences D-A-B-C | Experimental | Treatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).). Receives: Drug: Elinzanetant (BAY3427080); Drug: Placebo to elinzanetant; Drug: Zopiclone; Drug: Placebo to zopiclone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulated driving performance as measured by SDLP using CRCDS-MiniSim
SDLP: standard deviation of lateral position. CRCDS-MiniSim: Cognitive Research Corporation's Driving Simulator-MiniSim.
Measured: Approximately 9 hours after last dose
Secondary outcomes (14)
Lane Exceedance: Number of Exceedance.
Measured: Approximately 9 hours after last dose
Lane Exceedance: Maximum Duration of Exceedance.
Measured: Approximately 9 hours after last dose
Lane Exceedance: Area of Exceedance.
Measured: Approximately 9 hours after last dose
Excessive Speed Count
Measured: Approximately 9 hours after last dose
Average Speed and Speed Deviation
Measured: Approximately 9 hours after last dose
Driving safety measures: Total number of excessive Ay (cornering speed threshold-exceeded)
Measured: Approximately 9 hours after last dose
Driving safety measures: Total number of collisions
Measured: Approximately 9 hours after last dose
Divided Attention: Correct responses; Omission Errors; Commission Errors; Reaction Time; Standard Deviation of Reaction Time
Measured: Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Number of Correct responses
CogScreen Symbol Digit Coding test is a computer analogue of the conventional digit symbol-substitution task found in the revised Wechsler intelligence scales.
Measured: Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Response Accuracy (percentage of correct responses)
Measured: Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Standard Deviation of Reaction Time
Measured: Approximately 9 hours after last dose
Karolinska Sleepiness Scale (KSS) Score
The KSS measures an individual's subjective level of sleepiness. Participants indicate their level of alertness versus sleepiness according to a 9-point scale, ranging from "extremely alert" to "extremely sleepy - fighting sleep".
Measured: Approximately 9 hours after last dose
Participant's self-reported Readiness to Drive
Prior to driving, the participant will be asked a simple question as to whether they feel safe to drive ("Right now do you feel safe to drive?"). Participant will answer "yes" or "no".
Measured: Approximately 9 hours after last dose
Self-report of motivation and appraisal of driving performance using VAS
Participants will record their response to each question by drawing a vertical line on a 100-mm horizontal, linear VAS printed on paper.
For the self-assessment of driving performance, one end of the line is marked "Not Satisfactory" and the other end of the line is marked "Satisfactory".
For the motivation item, 1 end of the line is marked "Not Motivated" and the other end is marked "Motivated".
Scores on the 100-mm linear scale will be measured to the nearest millimeter from the left with a ruler.
Measured: Approximately 9 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start8 Jan 2024
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219902
- Sponsor's protocol ID
- 22653
- Status last verified
- May 2024
- First submitted
- 21 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Francke K, Klein S, Burke J, Schultze-Mosgau MH, Kay G. The Effects of Elinzanetant on Simulated Driving Performance in Healthy Women: A Randomized Phase I Study. Clin Transl Sci. 2025 Jul;18(7):e70282. doi: 10.1111/cts.70282.
PubMed 40569207
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo- and Active-controlled, 4-period, Crossover Study to Investigate Effects of Elinzanetant on Simulated Driving Performance and Cognitive Function in Healthy Women
- ClinicalTrials.gov ID
- NCT06219902
- Acronym / sponsor ID
- 22653
- Keywords
- Driving performance,, Cognitive function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 23 Jan 2024 (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.
Researchers are looking for a better way to treat vasomotor symptoms (VMS), also known as hot flashes.
Hot flashes are intense and sudden feelings of heat along with sweating and reddening of the skin. These are common for women going through the menopause but can also occur in men. Such symptoms are called VMS and are caused by changes in sex hormone levels.
The study treatment, elinzanetant, is being tested for the treatment of VMS in both men and women. It works by blocking the activity of a substance called neurokinin, which is thought to play a role in starting hot flashes.
Elinzanetant may cause lasting effects like sleepiness and tiredness. Such effects may make driving unsafe.
The main purpose of this study is to learn how elinzanetant affects the ability to drive the next day in healthy women.
For this, researchers will study participants' ability to keep a stable position within their lane while driving on a straight road on a computer-based driving test (also known as a driving simulator).
In this study, participants will take 2 different doses of elinzanetant, another drug called zopiclone, and matching placebos to these drugs.
Zopiclone helps treat sleeping problems. A placebo looks like a study drug but does not have any medicine in it.
Participants will take elinzanetant, zopiclone, and their matching placebos by mouth.
This study will have 4 treatment periods with each period lasting 6 days. In each period, participants will receive one of the following treatments in an order assigned to them randomly (by chance):
- dose A of elinzanetant and a zopiclone placebo
- dose B of elinzanetant and a zopiclone placebo
- zopiclone 7.5 milligrams (mg) and elinzanetant placebo
- elinzanetant placebo and zopiclone placebo
Each participant will be in the study for around 15 weeks with up to 6 visits to the study site.
Participants will visit the study site:
- once before the treatment starts, so the study doctors and their team can check on their health and confirm if the participant can join the study
- once in each of the 4 treatment periods for a 6-day stay at the study site with a gap of 14 days between each period. During each stay, they will take the assigned treatment from Days 1 to 5 and the driving test on Days 2 and 6
- once, 2 to 3 days after their last treatment so the study doctors and their team can check on their health
During the study, the doctors and their study team will:
- check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
- check the participants' ability to drive and their brain function and level of sleepiness using different tests including a driving simulator test
- check the level of the study drugs in participants' blood
- ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment or not.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment sequences A-C-D-B | Experimental | Drug: Elinzanetant (BAY3427080), Drug: Placebo to elinzanetant, Drug: Zopiclone, Drug: Placebo to zopicloneTreatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo). |
| Treatment sequences B-D-C-A | Experimental | Drug: Elinzanetant (BAY3427080), Drug: Placebo to elinzanetant, Drug: Zopiclone, Drug: Placebo to zopicloneTreatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo). |
| Treatment sequences C-B-A-D | Experimental | Drug: Elinzanetant (BAY3427080), Drug: Placebo to elinzanetant, Drug: Zopiclone, Drug: Placebo to zopicloneTreatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo). |
| Treatment sequences D-A-B-C | Experimental | Drug: Elinzanetant (BAY3427080), Drug: Placebo to elinzanetant, Drug: Zopiclone, Drug: Placebo to zopicloneTreatment A (elinzanetant dose A). Treatment B (elinzanetant dose B). Treatment C (zopiclone 7.5 mg). Treatment D (placebo).). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females aged 40 to 65 years, inclusive, at signing of informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and electrocardiogram (ECG).
- Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).
- Participant possesses a valid driver's license and is an active driver. Drives a minimum of 8,000 kilometers per year for the previous 3 years.
Key exclusion criteria (4 listed)
- Relevant diseases within the last 4 weeks prior to the first administration of study intervention, including febrile illness.
- A history within 2 years of, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the participant's sleep.
- Abnormal finding in the physical examination, ECG, blood pressure, pulse rate or clinical laboratory results at Screening, that are considered clinically significant by the investigator.
- Use of any medication of dietary supplement which may affect central nervous system (CNS) function and may confound the pharmacodynamic assessments of the study.
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 |
|---|---|---|
| Elinzanetant (BAY3427080)Oral administration of multiple doses of elinzanetant. | Drug | Treatment sequences A-C-D-B, Treatment sequences B-D-C-A, Treatment sequences C-B-A-D, Treatment sequences D-A-B-C |
| Placebo to elinzanetantOral administration | Drug | Treatment sequences A-C-D-B, Treatment sequences B-D-C-A, Treatment sequences C-B-A-D, Treatment sequences D-A-B-C |
| ZopicloneOral administration | Drug | Treatment sequences A-C-D-B, Treatment sequences B-D-C-A, Treatment sequences C-B-A-D, Treatment sequences D-A-B-C |
| Placebo to zopicloneOral administration | Drug | Treatment sequences A-C-D-B, Treatment sequences B-D-C-A, Treatment sequences C-B-A-D, Treatment sequences D-A-B-C |
Primary outcome
Simulated driving performance as measured by SDLP using CRCDS-MiniSim
Time frame: Approximately 9 hours after last dose
SDLP: standard deviation of lateral position. CRCDS-MiniSim: Cognitive Research Corporation's Driving Simulator-MiniSim.
14 secondary outcomes
Lane Exceedance: Number of Exceedance.
Time frame: Approximately 9 hours after last dose
Lane Exceedance: Maximum Duration of Exceedance.
Time frame: Approximately 9 hours after last dose
Lane Exceedance: Area of Exceedance.
Time frame: Approximately 9 hours after last dose
Excessive Speed Count
Time frame: Approximately 9 hours after last dose
Average Speed and Speed Deviation
Time frame: Approximately 9 hours after last dose
Driving safety measures: Total number of excessive Ay (cornering speed threshold-exceeded)
Time frame: Approximately 9 hours after last dose
Driving safety measures: Total number of collisions
Time frame: Approximately 9 hours after last dose
Divided Attention: Correct responses; Omission Errors; Commission Errors; Reaction Time; Standard Deviation of Reaction Time
Time frame: Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Number of Correct responses
Time frame: Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Response Accuracy (percentage of correct responses)
Time frame: Approximately 9 hours after last dose
CogScreen Symbol Digit Coding Test: Standard Deviation of Reaction Time
Time frame: Approximately 9 hours after last dose
Karolinska Sleepiness Scale (KSS) Score
Time frame: Approximately 9 hours after last dose
Participant's self-reported Readiness to Drive
Time frame: Approximately 9 hours after last dose
Self-report of motivation and appraisal of driving performance using VAS
Time frame: Approximately 9 hours after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 40569207Francke K, Klein S, Burke J, Schultze-Mosgau MH, Kay G. The Effects of Elinzanetant on Simulated Driving Performance in Healthy Women: A Randomized Phase I Study. Clin Transl Sci. 2025 Jul;18(7):e70282. doi: 10.1111/cts.70282.
- Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Elinzanetant (BAY3427080) and Zopiclone in people with Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men and Hot Flashes, run by Bayer at 1 site in Canada.
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 4 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 8 May 2024. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Simulated driving performance as measured by SDLP using CRCDS-MiniSim (time frame: Approximately 9 hours after last dose). 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 NCT06219902, 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 8 May 2024.