PerimenopauseNCT07619352
Evaluation of the Effects of Lifestyle Medicine and Mindfulness-based Group Medical Visits on Stress, Microbiome, and Quality of Life in Women Experiencing Perimenopause and Menopause
A study testing Navigating Menopause with a Mindfulness-Based Group Medical Visit in people with Perimenopause and Menopause, run by Ohio State University at 1 site in United States.
Trial summary
While perimenopause and menopause are natural biological transitions, women may experience a wide range of physical, emotional, and cognitive symptoms. Although pharmacological options for symptom relief are available, these options may not be acceptable or suitable for all women. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Perimenopause, Menopause
- What is being tested?
- Navigating Menopause with a Mindfulness-Based Group Medical Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Biological female.
- Age 40 to 60.
- Irregular menstruation for 3 months and experiencing perimenopause or menopause as determined by reporting at least one symptom on the Menopause Quality of Life Questionnaire (MENQOL).
- Ability to attend group medical visits monthly, in-person for 8 months, at The Ohio State University Center for Integrative Health as well as the baseline and end of study visit.
- Ability to participate in the Mindfulness in Motion (MIM) study activities.
- Ability and willingness to download MyCap, the smartphone app that securely links participant study responses to the REDCap study project.
- WiFi connectivity or LTE to allow use of MyCap when not at OSU study site
Who cannot join
- Participants with surgically induced menopause, e.g., hysterectomy, oophorectomy.
- Currently receiving or planning to receive hormone therapy for perimenopausal or menopausal symptoms.
- Currently taking or planning to take hormonal contraceptives.
- Currently taking or planning to take hormone altering medications; i.e. Taxol.
- Currently taking probiotics, Siberian rhubarb (Rheum rhaponticum), Black cohosh (Actaea racemosa), Chaste tree berry (Vitex agnus-castus).
- Inability to read and/or understand English (consent and questionnaires in English).
Show all 9Show fewer
- Current severe alcohol or substance abuse disorder.
- Participants with documented cognitive disorder that limits the ability to independently read, understand, and/or complete the survey or biological; i.e. dementia, Alzheimer's or biological tests.
- Participants with major psychiatric disorders not controlled by medication or other psychiatric treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University
Columbus, Ohio, 43210
Beth Steinberg, PhD, RN, 614-406-7067, beth.steinberg@osumc.edu
Maryanna Klatt, PhD, 614-293-3644, maryanna.klatt@osumc.edu
About this study
Official title: A Pilot Study to Evaluate the Effects of Lifestyle Medicine and Mindfulness-based Group Medical Visits on Stress, Microbiome, and Quality of Life in Women Experiencing Perimenopause and Menopause
While perimenopause and menopause are natural biological transitions, women may experience a wide range of physical, emotional, and cognitive symptoms. Although pharmacological options for symptom relief are available, these options may not be acceptable or suitable for all women. Integrative approaches for symptom relief, offered through group medical visits, may complement traditional therapies by increasing access to providers, allowing more time for focused education, and fostering supportive discussions with other women experiencing similar symptoms of perimenopause or menopause.
The purpose of this study is to assess the effectiveness of eight monthly group medical visits that incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Individual outcomes, obtained before the group medical visits begin, at each monthly group medical visit, and four months after the group medical visits are completed, will include measures of participants' perimenopause or menopause symptoms, stress, inflammation, microbiome (good bacteria in the body), height/weight, body mass index (BMI), systolic and diastolic blood pressure, and self-reported perceptions of physical, mental, and social health.
Each 120-minute monthly group medical visit, led by a specially trained nurse practitioner and a mindfulness instructor, will include a brief physical assessment, educational discussions related to menopause and lifestyle medicine, experiential mindfulness practices, and the development of individual health and well-being goals.
Read the detailed description
Group Medical Visits (GMVs), also known as Shared Medical Appointments (SMAs), were introduced in literature in the 1970s, and despite support from organizations such as the American Academy of Family Physicians they have been slow to gain traction in the healthcare field. GMVs provide benefits to patients including increased access and time with the provider, improved quality of care, nonpharmacologic treatment, and the ability to share self-management tools. There is evidence that the GMV experience may impact clinical outcomes in patients with various diseases and conditions such as chronic pain, diabetes, breast cancer, and Multiple Sclerosis. However, the effects of GMVs on clinical and non-clinical outcomes for women - particularly for female-specific conditions like menopause - are not well established.
There is a clear demand for innovative and accessible care models like GMVs to address gaps in menopause care for women. More recently, a number of women are opting out of hormone therapy for menopause and exploring more integrative, holistic approaches to healthcare. Alternative approaches may include Lifestyle Medicine (LM) and mindfulness-based practices. Studies have demonstrated that mindfulness strategies, like meditation or yoga, can be a beneficial component to GMVs. Lifestyle Medicine, as defined by American College of Lifestyle Medicine (ACLM) is a "medical specialty that uses therapeutic lifestyle interventions as a primary modality to treat chronic conditions including, but not limited to, cardiovascular diseases, type 2 diabetes, and obesity". When applied intensively, Lifestyle Medicine has even been shown to reverse chronic conditions. Furthermore, Lifestyle Medicine interventions based on diet, physical activity and sleep hygiene have been shown to improve cardiometabolic outcomes. These types of choices for menopause interventions need support from knowledgeable providers of integrative techniques.
In addition to lifestyle and mindfulness-based interventions, investigating physiological factors in stress such as the microbiome offers a more comprehensive view of health during menopause. The gut microbiome, which consists of the ecosystem of microorganisms inhabiting the gastrointestinal tract, is known to undergo significant changes with aging and menopause. As the gut microbiome plays a key role in psychological stress and overall health, a better understanding of the changes taking place in the microbiome during menopause will help identify areas for improvement and potential interventions for women during this transition.
The aim of this pilot study is to investigate the measurable effects of Lifestyle Medicine GMVs and mindfulness on stress, microbiome, and quality of life in women experiencing perimenopause and menopause. It is anticipated that the GMVs and mindfulness techniques will provide beneficial outcomes for those participating in the study, including a reduction of stress, inflammation, BMI, blood pressure and an increase in resilience. Additionally, the investigators anticipate positive trends in self-reported perceptions of health such as physical, mental, and social quality of life. Potential challenges, risks or pitfalls of the study include recruiting a diverse patient population, self-reported data are subject to bias, and the billing structure for GMVs.
This research is significant to women experiencing peri- and post-menopause as it will provide data for future studies to implement more effective, engaging models for managing their health and well-being. Provider-patient contact time has decreased over the years, which can lead to poor health outcomes for patients. GMVs facilitate group healthcare without sacrificing personalization, patient education, and clinical components such as measuring vitals. The implications on a societal level are potential outcomes such as increased access to patient-centered, integrative healthcare, as well as customized non-pharmacological treatment for menopausal women. GMVs provide, or augment, solutions for women who elect not to take hormonal therapy for menopause symptoms. This GMV for the menopausal population will be called Navigating Menopause with a Mindfulness-Based Group Medical Visit.
- Conditions
- Perimenopause, Menopause
- Being tested
- Navigating Menopause with a Mindfulness-Based Group Medical Visit
- Keywords
- perimenopause, menopause, stress, microbiome, quality of life, women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigating Menopause with a Mindfulness-Based Group Medical VisitOther
Over the course of eight months, the group medical visits will incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Each group medical visit will be 120 minutes in length and will include:
- Check-in/physical assessment/self-report surveys (15 min)
- Education/Lifestyle Medicine session (30-45 min)
- Mindfulness in Motion (MIM) (30 min)
- Goals/Questions and 1:1 visits as needed (30 min)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Research subjects will participate in eight monthly group medical visits that incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Each group medical visit will be 120 minutes in length. Receives: Other: Navigating Menopause with a Mindfulness-Based Group Medical Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure is the force exerted by circulating blood against the walls of blood vessels due to heart's pumping action. It is measured in mmHg. The upper number is the measurement during the heartbeat (systolic) and the lower number is while the heart is at rest (diastolic).
Measured: From enrollment to the end of the 12-month study period.
Body Mass Index
An indirect measure of body fat derived by dividing weight in kilograms by height in meters, squared.
Measured: From enrollment to the end of the 12-month study period
Secondary outcomes (7)
Salivary Alpha Amylase
Salivary α-amylase is a surrogate marker of sympathetic nervous system activity.
Measured: From enrollment to the end of the 12-month study period.
High sensitivity C-Reactive Protein (hs-CRP)
A measure of a protein produced in the liver in response to inflammation, injury or infection.
Measured: From enrollment to the end of the 12-month study period.
Perceived Stress Scale
The Perceived Stress Scale-10 (PSS-10) is a 10-item self-report measure of perceived stress. It is a measure of the degree to which situations in one's life are appraised as stressful over the past month. The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: From enrollment to the end of the 12-month study period.
PROMIS-29 V2.0
The PROMIS - 29 V2.0 is a comprehensive health assessment tool that used to assess functioning and well-being. It assesses seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social activity and sleep disturbance plus a pain intensity rating). Each domain has 4 items with the responses using a Likert-type scale of 1 through 5 with responses related to frequency or severity of symptoms and pain intensity on scale of 0-10. Scores around 50 represent the general population average. Worse than average: Scores above 55 generally indicate higher symptom burdens (Anxiety, Depression, Fatigue, Sleep, Pain Interference).Better than average: Scores below 45 indicate better functionality (Physical Function, Social Roles).
Measured: From enrollment to the end of the 12-month study period.
The Menopause-specific Quality of Life Questionnaire
The MENQOL is a 29-item self-report tool that assesses the impact of menopausal symptoms over the past month on health-related quality of life in the immediate post-menopausal period. Items are grouped into four domains of menopausal symptoms that include vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Responses to each item are first rated as "present" or "not present", and if present, a Likert scale is used to describe perceptions of how bothersome symptoms are ranging from zero (not bothersome) to six (extremely bothersome); possible scores on each item ranges from one to eight. Means are then computed for each subscale.
Measured: From enrollment to the end of the 12-month study period.
The Menstrual Distress Questionnaire
The Menstrual Distress Questionnaire (MEDI-Q) is a validated tool designed to comprehensively assess menstrual-related distress. It includes 25 items covering symptoms such as pain, cognitive changes, and gastrointestinal issues, evaluating their impact on functioning, quality of life, and frequency, and provides four overall indices for a complete assessment.A Total Score (MEDI-Q Total) represents overall menstrual distress burden and is derived from responses across all items. A total score >20 indicates clinical relevant menstrual distress.
Measured: From enrollment to the end of the 12-month study period.
Physical Activity Vital Sign
A self-report two question assessment designed to gage physical activity over past week (question 1) and over a typical week (questions 2). Activity is reported in minutes for both questions.
Measured: From enrollment to the end of the 12-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Steinberg, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619352
- Sponsor's protocol ID
- 20260389
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effects of Lifestyle Medicine and Mindfulness-based Group Medical Visits on Stress, Microbiome, and Quality of Life in Women Experiencing Perimenopause and Menopause
- ClinicalTrials.gov ID
- NCT07619352
- Acronym / sponsor ID
- 20260389
- Conditions
- Perimenopause, Menopause
- Keywords
- perimenopause, menopause, stress, microbiome, quality of life, women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 2 Jun 2026 (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.
While perimenopause and menopause are natural biological transitions, women may experience a wide range of physical, emotional, and cognitive symptoms. Although pharmacological options for symptom relief are available, these options may not be acceptable or suitable for all women. Integrative approaches for symptom relief, offered through group medical visits, may complement traditional therapies by increasing access to providers, allowing more time for focused education, and fostering supportive discussions with other women experiencing similar symptoms of perimenopause or menopause.
The purpose of this study is to assess the effectiveness of eight monthly group medical visits that incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Individual outcomes, obtained before the group medical visits begin, at each monthly group medical visit, and four months after the group medical visits are completed, will include measures of participants' perimenopause or menopause symptoms, stress, inflammation, microbiome (good bacteria in the body), height/weight, body mass index (BMI), systolic and diastolic blood pressure, and self-reported perceptions of physical, mental, and social health.
Each 120-minute monthly group medical visit, led by a specially trained nurse practitioner and a mindfulness instructor, will include a brief physical assessment, educational discussions related to menopause and lifestyle medicine, experiential mindfulness practices, and the development of individual health and well-being goals.
Detailed description
Group Medical Visits (GMVs), also known as Shared Medical Appointments (SMAs), were introduced in literature in the 1970s, and despite support from organizations such as the American Academy of Family Physicians they have been slow to gain traction in the healthcare field. GMVs provide benefits to patients including increased access and time with the provider, improved quality of care, nonpharmacologic treatment, and the ability to share self-management tools. There is evidence that the GMV experience may impact clinical outcomes in patients with various diseases and conditions such as chronic pain, diabetes, breast cancer, and Multiple Sclerosis. However, the effects of GMVs on clinical and non-clinical outcomes for women - particularly for female-specific conditions like menopause - are not well established.
There is a clear demand for innovative and accessible care models like GMVs to address gaps in menopause care for women. More recently, a number of women are opting out of hormone therapy for menopause and exploring more integrative, holistic approaches to healthcare. Alternative approaches may include Lifestyle Medicine (LM) and mindfulness-based practices. Studies have demonstrated that mindfulness strategies, like meditation or yoga, can be a beneficial component to GMVs. Lifestyle Medicine, as defined by American College of Lifestyle Medicine (ACLM) is a "medical specialty that uses therapeutic lifestyle interventions as a primary modality to treat chronic conditions including, but not limited to, cardiovascular diseases, type 2 diabetes, and obesity". When applied intensively, Lifestyle Medicine has even been shown to reverse chronic conditions. Furthermore, Lifestyle Medicine interventions based on diet, physical activity and sleep hygiene have been shown to improve cardiometabolic outcomes. These types of choices for menopause interventions need support from knowledgeable providers of integrative techniques.
In addition to lifestyle and mindfulness-based interventions, investigating physiological factors in stress such as the microbiome offers a more comprehensive view of health during menopause. The gut microbiome, which consists of the ecosystem of microorganisms inhabiting the gastrointestinal tract, is known to undergo significant changes with aging and menopause. As the gut microbiome plays a key role in psychological stress and overall health, a better understanding of the changes taking place in the microbiome during menopause will help identify areas for improvement and potential interventions for women during this transition.
The aim of this pilot study is to investigate the measurable effects of Lifestyle Medicine GMVs and mindfulness on stress, microbiome, and quality of life in women experiencing perimenopause and menopause. It is anticipated that the GMVs and mindfulness techniques will provide beneficial outcomes for those participating in the study, including a reduction of stress, inflammation, BMI, blood pressure and an increase in resilience. Additionally, the investigators anticipate positive trends in self-reported perceptions of health such as physical, mental, and social quality of life. Potential challenges, risks or pitfalls of the study include recruiting a diverse patient population, self-reported data are subject to bias, and the billing structure for GMVs.
This research is significant to women experiencing peri- and post-menopause as it will provide data for future studies to implement more effective, engaging models for managing their health and well-being. Provider-patient contact time has decreased over the years, which can lead to poor health outcomes for patients. GMVs facilitate group healthcare without sacrificing personalization, patient education, and clinical components such as measuring vitals. The implications on a societal level are potential outcomes such as increased access to patient-centered, integrative healthcare, as well as customized non-pharmacological treatment for menopausal women. GMVs provide, or augment, solutions for women who elect not to take hormonal therapy for menopause symptoms. This GMV for the menopausal population will be called Navigating Menopause with a Mindfulness-Based Group Medical Visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Navigating Menopause with a Mindfulness-Based Group Medical VisitResearch subjects will participate in eight monthly group medical visits that incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Each group medical visit will be 120 minutes in length. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Biological female.
- Age 40 to 60.
- Irregular menstruation for 3 months and experiencing perimenopause or menopause as determined by reporting at least one symptom on the Menopause Quality of Life Questionnaire (MENQOL).
- Ability to attend group medical visits monthly, in-person for 8 months, at The Ohio State University Center for Integrative Health as well as the baseline and end of study visit.
- Ability to participate in the Mindfulness in Motion (MIM) study activities.
Key exclusion criteria (9 listed)
- Participants with surgically induced menopause, e.g., hysterectomy, oophorectomy.
- Currently receiving or planning to receive hormone therapy for perimenopausal or menopausal symptoms.
- Currently taking or planning to take hormonal contraceptives.
- Currently taking or planning to take hormone altering medications; i.e. Taxol.
- Currently taking probiotics, Siberian rhubarb (Rheum rhaponticum), Black cohosh (Actaea racemosa), Chaste tree berry (Vitex agnus-castus).
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 |
|---|---|---|
| Navigating Menopause with a Mindfulness-Based Group Medical VisitOver the course of eight months, the group medical visits will incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Each group medical visit will be 120 minutes in length and will include: 1. Check-in/physical assessment/self-report surveys (15 min) 2. Education/Lifestyle Medicine session (30-45 min) 3. Mindfulness in Motion (MIM) (30 min) 4. Goals/Questions and 1:1 visits as needed (30 min) | Other | Intervention Group |
Primary outcome
Blood Pressure
Time frame: From enrollment to the end of the 12-month study period.
Blood pressure is the force exerted by circulating blood against the walls of blood vessels due to heart's pumping action. It is measured in mmHg. The upper number is the measurement during the heartbeat (systolic) and the lower number is while the heart is at rest (diastolic).
Body Mass Index
Time frame: From enrollment to the end of the 12-month study period
An indirect measure of body fat derived by dividing weight in kilograms by height in meters, squared.
7 secondary outcomes
Salivary Alpha Amylase
Time frame: From enrollment to the end of the 12-month study period.
High sensitivity C-Reactive Protein (hs-CRP)
Time frame: From enrollment to the end of the 12-month study period.
Perceived Stress Scale
Time frame: From enrollment to the end of the 12-month study period.
PROMIS-29 V2.0
Time frame: From enrollment to the end of the 12-month study period.
The Menopause-specific Quality of Life Questionnaire
Time frame: From enrollment to the end of the 12-month study period.
The Menstrual Distress Questionnaire
Time frame: From enrollment to the end of the 12-month study period.
Physical Activity Vital Sign
Time frame: From enrollment to the end of the 12-month study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigating Menopause with a Mindfulness-Based Group Medical Visit in people with Perimenopause and Menopause, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth A Steinberg, PhD, RN (614-406-7067, beth.steinberg@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: From enrollment to the end of the 12-month study period.). 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?
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 16 Oct 2026.