Genitourinary Syndrome of MenopauseLASER_2022NCT05305209
Laser Therapy for Treatment of Genitourinary Syndrome of Menopause (GSM) in Postmenopausal Women
A study testing Intervention group in people with Genitourinary Syndrome of Menopause, run by University of Malaga at 1 site in Spain.
Trial summary
This is a prospective, multi-centre, double blinded, randomized controlled trial, which will be conducted under a common protocol. The aim of this study is to evaluate the efficacy of vaginal laser for treatment of GSM (Genitourinary Syndrome of Menopause) compared to the sham procedure in postmenopausal women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Intervention group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 15 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of any age with established menopause of 5 years or more who report genitourinary discomfort, dyspareunia, sequelae, genital atrophy, voiding discomfort, voiding urgency or urinary incontinence. Postmenopausal status is defined if patients have at least 12 continuous months of amenorrhea for no other apparent reason or permanently elevated follicle-stimulating hormone (FSH) blood levels (≥30 mIU/mL).
- Patients who have had cancer treatment already completed and in the process of remission.
- Sexually active
- Nulliparous or who have had vaginal deliveries or caesarean section
- That they do not receive hormone replacement therapy in any of its routes of administration. If you received HRT, 4 months must have elapsed since stopping treatment before starting the trial protocol.
- Motivated and committed to complete the trial
Who cannot join
- According to the pelvic organ prolapse quantification system [POP-Q], POP>Stage 2, , severe urinary or fecal incontinence (FI) or any disease that could influence the study protocol. In addition, patients will be advised to refrain from vaginal practices for three days prior to each biopsy (one at the beginning and one at the end of treatment).
- Women who are not sexually active, do not have coital relationships, either with a partner or alone
- Women with recurrent cystitis or candidiasis
- Women with little motivation to participate in the trial
- Minors
- Patients who do not have the ability to comprehend or understand what participation in a clinical trial entail
Show all 11Show fewer
- Patients with severe psychiatric pathology (depression, anxiety)
- Patients with degenerative neurological pathology: either cognitive impairment or ALS, MS, diabetic neuropathy, etc.
- Patients with neuropathic genital pain (neuralgia or pudendal nerve entrapment)
- Vulvodynia, hyperalgesia, or genital allodynia
- Post-pelvic surgery of less than 3 months
Trial locations and contacts
1 site in 1 country.
Rocío Martín-Valero, PhD contact
About this study
Official title: Efficacy of K-laser as a Therapeutic Treatment of the Symptoms of Genitourinary Syndrome of Menopause (SGM) in Postmenopausal Women: a Randomized Clinical Trial
This is a prospective, multi-centre, double blinded, randomized controlled trial, which will be conducted under a common protocol.
The aim of this study is to evaluate the efficacy of vaginal laser for treatment of GSM (Genitourinary Syndrome of Menopause) compared to the sham procedure in postmenopausal women.
The study population is female subjects > 18 years old with symptoms of genitourinary syndrome of menopause (GSM) who have not menstruated for at least 5 years.
Read the detailed description
The clinical data will be analysed by comparing post-treatment data with the baseline data (clinical history, compliance with selection, inclusion and exclusion requirements, assessment of the muscle and pH, and questionnaires). The follow-up is for 6 weeks after the procedure, a physical examination will be passed again to assess whether the effects on the tissue are maintained once the treatment is finished (coloration, hydration, and mobility of the tissue). Two biopsies will be taken, once at the beginning of treatment and another at the end.
The symptoms of SGM worsen as the age of the subject advances, which is why a treatment is required that improves the symptoms in the long term and maintains them once the treatment is finished. For this reason, the objective is to carry out a randomized control study with a new K-Laser Cube device that minimizes the possible risks of conventional vaginal laser therapy.
The hypothesis is that women who will undergo vaginal K-Laser treatment will report an improvement not only in SGM, but also in pelvic floor dysfunctions. The objective in this pilot study will be to evaluate the effects of K-laser treatment on pelvic floor dysfunctions using validated and commonly used questionnaires.
Changes in vaginal pH measured by FSFI (Female Sexual Function Index) questionnaire and changes in the deep musculature with the PERFECT protocol and the OXFORD scale will be the primary endpoints of the study. The secondary endpoints include quality of life changes with the SF-12 (Short Form) health questionnaire and Cervantes Scale, CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire, PFDI-20 (Pelvic Floor Distress Inventory) questionnaire and the Menopause Rating Scale (MSR).
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Intervention group, Control Group
- Keywords
- GSM (genitourinary syndrome of menopause), laser treatment, postmenopausal condition, urinary incontinence, vulvovaginal atrophy
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
The patients will receive 12 minutes of intravaginal application with an average power of 1 watios and total applied energy of 720J and an extracavitary application for 4 minutes with an average power of 3 watios and a total dose of 720J with all effects at 200%, twice a week for 6 weeks.
Control GroupOther
The patients will receive 12 minutes of intravaginal application and 4 minutes of extracavitary application, twice a week for 6 weeks. The difference compared to the intervention of group 1 is that the device will be off and therefore will not emit energy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | They will receive the k-laser treatment with the k-laser Cube Plus 30 device Receives: Other: Intervention group |
| Control Group | Placebo comparator | They will receive a sham treatment with the k-laser Cube Plus 30 device turned off Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Vaginal pH
During the physical examination a sample of the mucosa will be extracted to check the acidity of the pH. This is a marker of the health of the vaginal flora and abnormalities in pH values will be determined by hormonal imbalances of oestrogens. A pH> 4.5 refers to a decrease in local vaginal defenses which predisposes to infections or inflammatory processes. The pH analysis is a valid tool to diagnose menopause equivalent to an analysis of the levels of the follicle-stimulating molecule (FSH) non-invasive and inexpensive.
Measured: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Change from Baseline in the deep musculature with the PERFECT protocol
Digital evaluation is essential during the examination of the pelvic floor muscles. For this, digital palpation and a pressure gauge will be used. Digital assessment is performed by inserting the index and middle fingers into the distal 3 centimetres of the vagina in a frontal plane.
The PERFECT protocol is described as an acronym for evaluating the main components of pelvic floor muscle contractility. The components are: P (power, score muscle strength according to the OXFORD scale), E (endurance, time the maximum contraction is maintained without loss of strength), R (repetitions, number of contractions with intervals of 4 to 10 seconds), F (number of fast contractions followed after a rest of 1 minute), ECT (every contraction timed: each contraction measured) that consists in evaluating each contraction before the beginning of the treatment, which allows individualizing the program.
Measured: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Analysis of the impact on QoL (Quality of life) with the FSFI (Female Sexual Function Index) questionnaire.
FSFI questionnaire assesses sexual function in women with pelvic floor dysfunction. It consists of 6 domains and 19 items (Cronbach's alpha coefficient =0.85). The maximum score is 36.0 (high level of sexual functional) and minimum score is 2.0 (low level of sexual functional). The domains are: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), pain (3 items).
Measured: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Secondary outcomes (5)
Analysis of the impact on QoL (Quality of life) with the SF-12 (Short Form) health questionnaire.
This questionnaire is the reduced Spanish version of the SF-36 general health questionnaire, which has 35 items divided into 8 dimensions (physical function, physical role, emotional role, social function, mental health, general health, body pain and vitality). The SF-12 questionnaire has 12 items distributed in 2 health components: physical (CSF) with a Cronbach's alpha coefficient of 0.85 and mental (CSM) with a Cronbach's alpha coefficient of 0.78. It is one of the most widely used generic instruments for evaluating health-related quality of life.
Measured: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Analysis of the impact on QoL (Quality of life) with Cervantes Scale
The Cervantes scale is a questionnaire to measure health-related quality of life. It is a tool specifically designed and validated for menopause in Spanish women, original in Spanish and adapted to our environment. The definitive scale consists of 31 items and 2 dimensions: menopause and health. 15 items are related to vasomotor symptomatology, health and aging; 4 items with sexuality; 3 items with the couple relationship and 9 items with psychic domain. The global Cronbach's alpha coefficient is 0.909 and that of the different subscales between 0.79 and 0.85. It is a short scale and easy and quick to apply, approximately 7 minutes. The bases fluctuate between 0 (best quality of life) and 155 (worst quality of life). Its age of application is the Spanish female population between 45 and 64 years old and it has scales to compare the results with younger women or of the same age.
Measured: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Assessment of pain with the CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire
This questionnaire consists of 7 questions and is a screening tool to identify patients and include them in treatment programs, it allows the evaluation of results for treatments and clinical trials, as well as evaluating the prevalence of chronic pelvic pain in epidemiological studies. For the preparation of the CPPQ-Mohedo questionnaire, the NIH-CPSI (questionnaire for the evaluation of chronic prostatitis, male sex) was used and to test the ability to discriminate between healthy and unhealthy individuals, women and men, a paired study was carried out: 40 unhealthy men with 40 unhealthy women, each of whom was matched with six healthy controls for age and sex (480 total). Finally, CPPQ-Mohedo showed a similar discriminant capacity between men and women. The dimensions involved (pain and quality of life) showed internal consistency, with Cronbach's alpha coefficient being 0.75.
Measured: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Evaluation of the impact of pelvic floor dysfunction symptoms with the PFDI-20 (Pelvic Floor Distress Inventory) questionnaire
This questionnaire is the validated Spanish version of the Pelvic Floor Distress Inventory Short Form (PFDI-20). It is a reliable and valid instrument to assess symptoms and quality of life in Spanish women with pelvic floor dysfunction. The Spanish version achieved good semantic, conceptual, idiomatic, and content equivalence, with Cronbach's alpha coefficient being 0.837. This questionnaire has 20 items grouped into 3 components: Genital Prolapse Symptom Impact Questionnaire (POPDI, Cronbach's alpha= 0.787) with 6 items that assess symptoms of genital prolapse; Colorectal-Anal Symptom Impact Questionnaire (CRADI, Cronbach's alpha= 0.630) with 8 items that assess colorectal-anal symptoms; Urinary Symptom Impact Questionnaire (UDI, Cronbach's alpha= 0.699) with 6 items that assess urinary symptoms.
Measured: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Assesment of menopausal symptoms with the Menopause Rating Scale (MSR).
The Menopause Rating Scale (MRS) is a tool to assess the health-related quality of life of menopausal women. It is a standardized scale that meets psychometric standards, versioned in 9 languages. The scale was designed and standardized as a self-administered scale to (a) assess symptoms, (b) to assess the severity of symptoms over time, and (c) to measure changes before and after replacement therapy. menopause. It consists of 11 items (symptoms and complaints) evaluated from 0 (no complaint) to 4 (severe symptom). The degree of internal consistency (Cronbach's alpha coefficient) varies by country, ranging between 0.6 and 0.9.
Measured: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Antonia Maria Ruiz Moreno, María Dolores Martínez Colmena, María del Carmen Iniesta Moreno, María Lydia Serra Llosa
- Responsible party
- Principal investigator, Rocío Martín Valero, University of Malaga
- Investigators
- Rocío Martín-Valero, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305209
- Sponsor's protocol ID
- UMA _SGM_2022
- Acronym
- LASER_2022
- Status last verified
- May 2022
- First submitted
- 15 Mar 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of K-laser as a Therapeutic Treatment of the Symptoms of Genitourinary Syndrome of Menopause (SGM) in Postmenopausal Women: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05305209
- Acronym / sponsor ID
- LASER_2022 / UMA _SGM_2022
- Conditions
- Genitourinary Syndrome of Menopause
- Keywords
- GSM (genitourinary syndrome of menopause), laser treatment, postmenopausal condition, urinary incontinence, vulvovaginal atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Antonia Maria Ruiz Moreno, María Dolores Martínez Colmena, María del Carmen Iniesta Moreno, María Lydia Serra Llosa
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 31 Mar 2022 (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.
This is a prospective, multi-centre, double blinded, randomized controlled trial, which will be conducted under a common protocol.
The aim of this study is to evaluate the efficacy of vaginal laser for treatment of GSM (Genitourinary Syndrome of Menopause) compared to the sham procedure in postmenopausal women.
The study population is female subjects > 18 years old with symptoms of genitourinary syndrome of menopause (GSM) who have not menstruated for at least 5 years.
Detailed description
The clinical data will be analysed by comparing post-treatment data with the baseline data (clinical history, compliance with selection, inclusion and exclusion requirements, assessment of the muscle and pH, and questionnaires). The follow-up is for 6 weeks after the procedure, a physical examination will be passed again to assess whether the effects on the tissue are maintained once the treatment is finished (coloration, hydration, and mobility of the tissue). Two biopsies will be taken, once at the beginning of treatment and another at the end.
The symptoms of SGM worsen as the age of the subject advances, which is why a treatment is required that improves the symptoms in the long term and maintains them once the treatment is finished. For this reason, the objective is to carry out a randomized control study with a new K-Laser Cube device that minimizes the possible risks of conventional vaginal laser therapy.
The hypothesis is that women who will undergo vaginal K-Laser treatment will report an improvement not only in SGM, but also in pelvic floor dysfunctions. The objective in this pilot study will be to evaluate the effects of K-laser treatment on pelvic floor dysfunctions using validated and commonly used questionnaires.
Changes in vaginal pH measured by FSFI (Female Sexual Function Index) questionnaire and changes in the deep musculature with the PERFECT protocol and the OXFORD scale will be the primary endpoints of the study. The secondary endpoints include quality of life changes with the SF-12 (Short Form) health questionnaire and Cervantes Scale, CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire, PFDI-20 (Pelvic Floor Distress Inventory) questionnaire and the Menopause Rating Scale (MSR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupThey will receive the k-laser treatment with the k-laser Cube Plus 30 device |
| Control Group | Placebo comparator | Other: Control GroupThey will receive a sham treatment with the k-laser Cube Plus 30 device turned off |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women of any age with established menopause of 5 years or more who report genitourinary discomfort, dyspareunia, sequelae, genital atrophy, voiding discomfort, voiding urgency or urinary incontinence. Postmenopausal status is defined if patients have at least 12 continuous months of amenorrhea for no other apparent reason or permanently elevated follicle-stimulating hormone (FSH) blood levels (≥30 mIU/mL).
- Patients who have had cancer treatment already completed and in the process of remission.
- Sexually active
- Nulliparous or who have had vaginal deliveries or caesarean section
- That they do not receive hormone replacement therapy in any of its routes of administration. If you received HRT, 4 months must have elapsed since stopping treatment before starting the trial protocol.
Key exclusion criteria (11 listed)
- According to the pelvic organ prolapse quantification system [POP-Q], POP>Stage 2, , severe urinary or fecal incontinence (FI) or any disease that could influence the study protocol. In addition, patients will be advised to refrain from vaginal practices for three days prior to each biopsy (one at the beginning and one at the end of treatment).
- Women who are not sexually active, do not have coital relationships, either with a partner or alone
- Women with recurrent cystitis or candidiasis
- Women with little motivation to participate in the trial
- Minors
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 |
|---|---|---|
| Intervention groupThe patients will receive 12 minutes of intravaginal application with an average power of 1 watios and total applied energy of 720J and an extracavitary application for 4 minutes with an average power of 3 watios and a total dose of 720J with all effects at 200%, twice a week for 6 weeks. | Other | Intervention group |
| Control GroupThe patients will receive 12 minutes of intravaginal application and 4 minutes of extracavitary application, twice a week for 6 weeks. The difference compared to the intervention of group 1 is that the device will be off and therefore will not emit energy. | Other | Control Group |
Primary outcome
Change from Baseline in Vaginal pH
Time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
During the physical examination a sample of the mucosa will be extracted to check the acidity of the pH. This is a marker of the health of the vaginal flora and abnormalities in pH values will be determined by hormonal imbalances of oestrogens. A pH> 4.5 refers to a decrease in local vaginal defenses which predisposes to infections or inflammatory processes. The pH analysis is a valid tool to diagnose menopause equivalent to an analysis of the levels of the follicle-stimulating molecule (FSH) non-invasive and inexpensive.
Change from Baseline in the deep musculature with the PERFECT protocol
Time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Digital evaluation is essential during the examination of the pelvic floor muscles. For this, digital palpation and a pressure gauge will be used. Digital assessment is performed by inserting the index and middle fingers into the distal 3 centimetres of the vagina in a frontal plane. The PERFECT protocol is described as an acronym for evaluating the main components of pelvic floor muscle contractility. The components are: P (power, score muscle strength according to the OXFORD scale), E (endurance, time the maximum contraction is maintained without loss of strength), R (repetitions, number of contractions with intervals of 4 to 10 seconds), F (number of fast contractions followed after a rest of 1 minute), ECT (every contraction timed: each contraction measured) that consists in evaluating each contraction before the beginning of the treatment, which allows individualizing the program.
Analysis of the impact on QoL (Quality of life) with the FSFI (Female Sexual Function Index) questionnaire.
Time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
FSFI questionnaire assesses sexual function in women with pelvic floor dysfunction. It consists of 6 domains and 19 items (Cronbach's alpha coefficient =0.85). The maximum score is 36.0 (high level of sexual functional) and minimum score is 2.0 (low level of sexual functional). The domains are: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), pain (3 items).
5 secondary outcomes
Analysis of the impact on QoL (Quality of life) with the SF-12 (Short Form) health questionnaire.
Time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Analysis of the impact on QoL (Quality of life) with Cervantes Scale
Time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Assessment of pain with the CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire
Time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Evaluation of the impact of pelvic floor dysfunction symptoms with the PFDI-20 (Pelvic Floor Distress Inventory) questionnaire
Time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Assesment of menopausal symptoms with the Menopause Rating Scale (MSR).
Time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocío Martín-Valero, PhD contact
Rocío Martín-Valero, PhD principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Genitourinary Syndrome of Menopause, run by University of Malaga at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 18 May 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 Spain. 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.
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 Rocío Martín-Valero, PhD (34 951 952 858, rovalemas@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Vaginal pH (time frame: The evaluation will be done at baseline before treatment and 6 weeks post treatment). The study lists 3 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 18 May 2022.