Vestibulodynia (VBD) From at Least 6 MonthsNCT05156489
Ultrasound Evaluation and Vestibular Perception Thresholds Changes in Women Affected by Vestibulodynia (VBD) After One Cycle of Pixel CO2-Alma Fractionated Laser
A study testing Fractionated Laser (Pixel CO2-Alma) in people with Vestibulodynia (VBD) From at Least 6 Months, run by Dr. Filippo Murina at 1 site in Italy.
Trial summary
Vestibulodynia (VBD), term revised by Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia in 2015, is a vulvar pain of at least 3 months' duration, without clear identifiable cause and localized at vestibuli. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vestibulodynia (VBD) From at Least 6 Months
- What is being tested?
- Fractionated Laser (Pixel CO2-Alma)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2022to Aug 2022
- Phase
- Interventional
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women affected by Vestibulodynia (VBD) from 6 months.
- Women older than 18 years and not yet in menopausa period (12 consecutive months without a menstrual period).
- Vulval pain from moderate to severe (in a Likert scale between 0 =absent and 10 =severe, scored at least 5 after sexual intercourse with penetration).
- Pain localized at vestibuli during sexual intercourse or in activities with pressure on vestibuli (ie bike, horsing).
- Willingness to provide informed consent
- Willing to have sexual intercourse in the study period
Who cannot join
- Hypersensitivity or intolerance to laser.
- Clinically significant findings on physical examination.
- Any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study.
- Pelvic floor hypertonicity (from moderate to severe) evaluated at screening by the Investigator and scored on a Likert scale between 0 = hypertonicity absent and 3 =severe hypertonicity.
- Active vaginal or vulvar infections (e.g., herpes, candida, STIs)
- Uterine prolapse beyond the hymen.
Show all 9Show fewer
- Subject has a history of scarring alteration (ie, keloid formation).
- Unknown past or active history of vaginal bleeding disorders.
- Any condition or behavior indicating to the Investigator that the subject is unlikely to be compliant with study procedures and visits.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale dei Bambini "Vittore Buzzi"
Milan, 20154
Filippo Murina Murina, +390263635420, filippo.murina@asst-fbf-sacco.it
Filippo Murina Murina
About this study
Official title: An Open-Label, Interventional, Not Controlled Pilot Study to Assess Vestibular Mucosa Thickness by Ultrasound Evaluation and Vestibular Perception Thresholds Changes in Women Affected by Vestibulodynia (VBD) After One Cycle of Pixel CO2-Alma Fractionated Laser
Vestibulodynia (VBD), term revised by Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia in 2015, is a vulvar pain of at least 3 months' duration, without clear identifiable cause and localized at vestibuli.
Women affected by this disease report localized hypersensitivity and pain of the vulvar vestibule to the touch (eg, during sexual intercourse or tampon use). This pattern of responses is suggestive of sensory abnormalities in the form of evoked pain (eg, hyperalgesia or allodynia).
Read more
Research biopsy studies have demonstrated increased innervation of the vulvar vestibule and increased subepithelial heparinase activity and cytokines that have been associated with neuroinflammatory processes. In addition, the discomfort inherent in VBD is always associated with pelvic floor muscle overactivity, with the development of myofascial trigger points, resulting in localized or radiating pain and/or severe tenderness.
A rich nerve plexus was identified within the vaginal submucosa, which was only composed of sympathetic and parasympathetic axons, with contributions of smaller sensory fibers. The sensory nerve endings of the vulvar vestibule are dense and shallow, making this region more physiologically sensitive. Several works suggest that a thinner vestibular mucosa is more sensitive to nociception because nerve endings become more superficial, thus altering the transduction of mechanical pressure to facilitate nociception.
The CO2 fractionated laser, has been used to safely and effectively treat symptomatic vaginal atrophy. This tool has also been found to be useful in the treatment of vestibulodynia.
In this open pilot study, 30 female subjects aged more 18 years old at inclusion, having symptoms of VBD from at least 6 months, have given her informed consent and meet all the eligibility criteria, will be enrolled. The subjects will be treated with CO2 Fractionated Laser into vestibule, for 3 sessions at monthly intervals with a follow up of 4 months. Subjects will come to a total of 6 visits over a period of 3 months.
The primary objectives of the study are to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser in women affected by VBD by the assessment of vestibular mucosa thickness by ultrasound evaluation and vestibular perception thresholds changes at day 84 and 120 and by searching the adverse event during all the study. The secondary objectives are the assessment of VAS for burning/pain, and dyspareunia, evaluation of pain and hypersensitivity to the touch by Swab test, Female Sexual Function Index (FSFI) and by Vulval Pain Functional Questionnaire (VQ) at the visits.
- Being tested
- Fractionated Laser (Pixel CO2-Alma)
- Keywords
- Vestibulodynia (VBD), Fractionated Laser, Vaginal dryness.
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated Laser (Pixel CO2-Alma)Device
The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28±4) and at visit 4 (day 56±4) into vestibule, following the IFU of the device.
| Study group | Role | What they receive |
|---|---|---|
| Fractionated Laser | Experimental | Not described Receives: Device: Fractionated Laser (Pixel CO2-Alma) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vestibular mucosa thickness measured in µm by B-scan ultrasonography (DermaScan C, Cortex Technology, Denmark)
The Investigator will use B-scan ultrasonography with a 20-MHz validated system. The changing was evaluated from baseline to day 84 (visit 5), and 120 (final visit).
Measured: 120 days
Vestibular perception thresholds measured with values from 1 to 25 by Neurometer CPT (Neurotron, Inc, Baltimore, MD)
In Vestibular perception thresholds (VPT) a value ranging from 6 to 13 is classified as normal, while a value ranging from 1 to 5 show hyperesthesia. A value between 14 and 25 shows hypoesthesia.
The changing was evaluated from baseline to day 84 (visit 5), and 120 (final visit).
Measured: 120 days
Secondary outcomes (7)
Dyspareunia by Visual Analogue Scale
The changing will be measured by Visual Analogue Scale (VAS) mean value from baseline to day 84 (visit 5), and 120 (final visit). The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms.
Measured: 120 days
Burning/pain by Visual Analogue Scale
The changing will be measured by Visual Analogue Scale (VAS) mean value from baseline to day 84 (visit 5), and 120 (final visit). The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms.
Measured: 120 days
Pain/hypersensitivity to the touch at Swab test measured by Visual Analogue Scale.
The changing from baseline to day 84 (visit 5), and 120 (final visit) will be reported in a Visual Analogue Scale (VAS). The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms.
Measured: 120 days
Sexual Function by Female Sexual Function Index
Sexual function will be evaluated at baseline and after 84 and 120 days by the Italian validated translation of the Female Sexual Function Index (FSFI), a self-report instrument consisting of 19 items that assess sexual function over the past 4 weeks in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. Mean value in each group separately and in the two groups in comparison will be analyzed.
Measured: 120 days
Vulval pain by Vulval Pain Functional Questionnaire (VQ)
In the Vulval Pain Functional Questionnaire (VQ) a numerical value is assigned to each response. The higher the score the greater the functional limitation. A diminishing score represents improvement.
Measured: 120 days
Vestibular trophism by the Vestibular Health Score
Vestibular Health Score (VHS) will be used by the Investigator evaluating 5 parameters (Petechiae, Pallor, Fragility, Dryness, Erythema) which lead to obtain a final score defining the degree of atrophy. Each item is scored on a Likert scale between 0 =absent and 3 =severe. Total scores range from 0 to 15.
Measured: 120 days
Incidence of Treatment-Emergent Adverse Events/ Adverse Device Events/ Serious Adverse Events/ Serious Adverse Device Events [Safety and Tolerability]
The incidence will be calculated by searching for Adverse Event (AE), Adverse Device Event ADE, Serious Adverse Event (SAE), Serious Adverse Device Event (SADE) at each visit
Measured: up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start30 Jan 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Vestibulodynia (VBD) From at Least 6 MonthsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot open not comparative
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Filippo Murina
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor-investigator, Dr. Filippo Murina, ASST Fatebenefratelli Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156489
- Sponsor's protocol ID
- SDSV-2020-03.1
- Status last verified
- Dec 2021
- First submitted
- 26 Oct 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bornstein J, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, Coady D; consensus vulvar pain terminology committee of the International Society for the Study of Vulvovaginal Disease (ISSVD); International Society for the Study of Women's Sexual Health (ISSWSH); International Pelvic Pain Society (IPPS). 2015 ISSVD, ISSWSH, and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia. J Sex Med. 2016 Apr;13(4):607-12. doi: 10.1016/j.jsxm.2016.02.167. Epub 2016 Mar 25.
PubMed 27045260Goldstein AT, Pukall CF, Brown C, Bergeron S, Stein A, Kellogg-Spadt S. Vulvodynia: Assessment and Treatment. J Sex Med. 2016 Apr;13(4):572-90. doi: 10.1016/j.jsxm.2016.01.020. Epub 2016 Mar 25.
PubMed 27045258Wesselmann U, Bonham A, Foster D. Vulvodynia: Current state of the biological science. Pain. 2014 Sep;155(9):1696-1701. doi: 10.1016/j.pain.2014.05.010. Epub 2014 May 22. No abstract available.
PubMed 24858303Morin M, Binik YM, Bourbonnais D, Khalife S, Ouellet S, Bergeron S. Heightened Pelvic Floor Muscle Tone and Altered Contractility in Women With Provoked Vestibulodynia. J Sex Med. 2017 Apr;14(4):592-600. doi: 10.1016/j.jsxm.2017.02.012.
PubMed 28364981Farmer MA. What is special about the vulvar vestibule? Pain. 2015 Mar;156(3):359-360. doi: 10.1097/j.pain.0000000000000094.
PubMed 25687538Murina F, Barbieri S, Lubrano C, Cetin I. Vestibular Mucosa Thickness Measured by Ultrasound in Patients Affected by Vestibulodynia: A Case-Control Study. Sex Med. 2021 Apr;9(2):100320. doi: 10.1016/j.esxm.2020.100320. Epub 2021 Feb 13.
PubMed 33588370Salvatore S, Athanasiou S, Candiani M. The use of pulsed CO2 lasers for the treatment of vulvovaginal atrophy. Curr Opin Obstet Gynecol. 2015 Dec;27(6):504-8. doi: 10.1097/GCO.0000000000000230.
PubMed 26536212Murina F, Karram M, Salvatore S, Felice R. Fractional CO2 Laser Treatment of the Vestibule for Patients with Vestibulodynia and Genitourinary Syndrome of Menopause: A Pilot Study. J Sex Med. 2016 Dec;13(12):1915-1917. doi: 10.1016/j.jsxm.2016.10.006. Epub 2016 Nov 15.
PubMed 27864031
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Interventional, Not Controlled Pilot Study to Assess Vestibular Mucosa Thickness by Ultrasound Evaluation and Vestibular Perception Thresholds Changes in Women Affected by Vestibulodynia (VBD) After One Cycle of Pixel CO2-Alma Fractionated Laser
- ClinicalTrials.gov ID
- NCT05156489
- Acronym / sponsor ID
- SDSV-2020-03.1
- Keywords
- Vestibulodynia (VBD), Fractionated Laser, Vaginal dryness.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dr. Filippo MurinaUniversity, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 30 Jan 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 14 Dec 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.
Vestibulodynia (VBD), term revised by Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia in 2015, is a vulvar pain of at least 3 months' duration, without clear identifiable cause and localized at vestibuli.
Women affected by this disease report localized hypersensitivity and pain of the vulvar vestibule to the touch (eg, during sexual intercourse or tampon use). This pattern of responses is suggestive of sensory abnormalities in the form of evoked pain (eg, hyperalgesia or allodynia).
Research biopsy studies have demonstrated increased innervation of the vulvar vestibule and increased subepithelial heparinase activity and cytokines that have been associated with neuroinflammatory processes. In addition, the discomfort inherent in VBD is always associated with pelvic floor muscle overactivity, with the development of myofascial trigger points, resulting in localized or radiating pain and/or severe tenderness.
A rich nerve plexus was identified within the vaginal submucosa, which was only composed of sympathetic and parasympathetic axons, with contributions of smaller sensory fibers. The sensory nerve endings of the vulvar vestibule are dense and shallow, making this region more physiologically sensitive. Several works suggest that a thinner vestibular mucosa is more sensitive to nociception because nerve endings become more superficial, thus altering the transduction of mechanical pressure to facilitate nociception.
The CO2 fractionated laser, has been used to safely and effectively treat symptomatic vaginal atrophy. This tool has also been found to be useful in the treatment of vestibulodynia.
In this open pilot study, 30 female subjects aged more 18 years old at inclusion, having symptoms of VBD from at least 6 months, have given her informed consent and meet all the eligibility criteria, will be enrolled. The subjects will be treated with CO2 Fractionated Laser into vestibule, for 3 sessions at monthly intervals with a follow up of 4 months. Subjects will come to a total of 6 visits over a period of 3 months.
The primary objectives of the study are to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser in women affected by VBD by the assessment of vestibular mucosa thickness by ultrasound evaluation and vestibular perception thresholds changes at day 84 and 120 and by searching the adverse event during all the study. The secondary objectives are the assessment of VAS for burning/pain, and dyspareunia, evaluation of pain and hypersensitivity to the touch by Swab test, Female Sexual Function Index (FSFI) and by Vulval Pain Functional Questionnaire (VQ) at the visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot open not comparative
| Arm | Type | Receives |
|---|---|---|
| Fractionated Laser | Experimental | Device: Fractionated Laser (Pixel CO2-Alma) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women affected by Vestibulodynia (VBD) from 6 months.
- Women older than 18 years and not yet in menopausa period (12 consecutive months without a menstrual period).
- Vulval pain from moderate to severe (in a Likert scale between 0 =absent and 10 =severe, scored at least 5 after sexual intercourse with penetration).
- Pain localized at vestibuli during sexual intercourse or in activities with pressure on vestibuli (ie bike, horsing).
- Willingness to provide informed consent
Key exclusion criteria (9 listed)
- Hypersensitivity or intolerance to laser.
- Clinically significant findings on physical examination.
- Any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study.
- Pelvic floor hypertonicity (from moderate to severe) evaluated at screening by the Investigator and scored on a Likert scale between 0 = hypertonicity absent and 3 =severe hypertonicity.
- Active vaginal or vulvar infections (e.g., herpes, candida, STIs)
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 |
|---|---|---|
| Fractionated Laser (Pixel CO2-Alma)The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28±4) and at visit 4 (day 56±4) into vestibule, following the IFU of the device. | Device | Fractionated Laser |
Primary outcome
Vestibular mucosa thickness measured in µm by B-scan ultrasonography (DermaScan C, Cortex Technology, Denmark)
Time frame: 120 days
The Investigator will use B-scan ultrasonography with a 20-MHz validated system. The changing was evaluated from baseline to day 84 (visit 5), and 120 (final visit).
Vestibular perception thresholds measured with values from 1 to 25 by Neurometer CPT (Neurotron, Inc, Baltimore, MD)
Time frame: 120 days
In Vestibular perception thresholds (VPT) a value ranging from 6 to 13 is classified as normal, while a value ranging from 1 to 5 show hyperesthesia. A value between 14 and 25 shows hypoesthesia. The changing was evaluated from baseline to day 84 (visit 5), and 120 (final visit).
7 secondary outcomes
Dyspareunia by Visual Analogue Scale
Time frame: 120 days
Burning/pain by Visual Analogue Scale
Time frame: 120 days
Pain/hypersensitivity to the touch at Swab test measured by Visual Analogue Scale.
Time frame: 120 days
Sexual Function by Female Sexual Function Index
Time frame: 120 days
Vulval pain by Vulval Pain Functional Questionnaire (VQ)
Time frame: 120 days
Vestibular trophism by the Vestibular Health Score
Time frame: 120 days
Incidence of Treatment-Emergent Adverse Events/ Adverse Device Events/ Serious Adverse Events/ Serious Adverse Device Events [Safety and Tolerability]
Time frame: up to 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Background: PubMed 27045260Bornstein J, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, Coady D; consensus vulvar pain terminology committee of the International Society for the Study of Vulvovaginal Disease (ISSVD); International Society for the Study of Women's Sexual Health (ISSWSH); International Pelvic Pain Society (IPPS). 2015 ISSVD, ISSWSH, and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia. J Sex Med. 2016 Apr;13(4):607-12. doi: 10.1016/j.jsxm.2016.02.167. Epub 2016 Mar 25.
- Background: PubMed 27045258Goldstein AT, Pukall CF, Brown C, Bergeron S, Stein A, Kellogg-Spadt S. Vulvodynia: Assessment and Treatment. J Sex Med. 2016 Apr;13(4):572-90. doi: 10.1016/j.jsxm.2016.01.020. Epub 2016 Mar 25.
- Background: PubMed 24858303Wesselmann U, Bonham A, Foster D. Vulvodynia: Current state of the biological science. Pain. 2014 Sep;155(9):1696-1701. doi: 10.1016/j.pain.2014.05.010. Epub 2014 May 22. No abstract available.
- Background: PubMed 28364981Morin M, Binik YM, Bourbonnais D, Khalife S, Ouellet S, Bergeron S. Heightened Pelvic Floor Muscle Tone and Altered Contractility in Women With Provoked Vestibulodynia. J Sex Med. 2017 Apr;14(4):592-600. doi: 10.1016/j.jsxm.2017.02.012.
- Background: PubMed 25687538Farmer MA. What is special about the vulvar vestibule? Pain. 2015 Mar;156(3):359-360. doi: 10.1097/j.pain.0000000000000094.
- Background: PubMed 33588370Murina F, Barbieri S, Lubrano C, Cetin I. Vestibular Mucosa Thickness Measured by Ultrasound in Patients Affected by Vestibulodynia: A Case-Control Study. Sex Med. 2021 Apr;9(2):100320. doi: 10.1016/j.esxm.2020.100320. Epub 2021 Feb 13.
- Background: PubMed 26536212Salvatore S, Athanasiou S, Candiani M. The use of pulsed CO2 lasers for the treatment of vulvovaginal atrophy. Curr Opin Obstet Gynecol. 2015 Dec;27(6):504-8. doi: 10.1097/GCO.0000000000000230.
- Background: PubMed 27864031Murina F, Karram M, Salvatore S, Felice R. Fractional CO2 Laser Treatment of the Vestibule for Patients with Vestibulodynia and Genitourinary Syndrome of Menopause: A Pilot Study. J Sex Med. 2016 Dec;13(12):1915-1917. doi: 10.1016/j.jsxm.2016.10.006. Epub 2016 Nov 15.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Laser (Pixel CO2-Alma) in people with Vestibulodynia (VBD) From at Least 6 Months, run by Dr. Filippo Murina at 1 site in Italy.
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 9 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: status not confirmed, as of the sponsor's last update on 14 Dec 2021. 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 Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filippo Murina, MD (+390263635420, filippo.murina@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vestibular mucosa thickness measured in µm by B-scan ultrasonography (DermaScan C, Cortex Technology, Denmark) (time frame: 120 days). The study lists 2 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 NCT05156489, which also lists 8 linked publications.
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 14 Dec 2021.