Activity of Chronic Inflammation in PCOS

July 28, 2024 updated by: Iwona Magdalena Gawron, Jagiellonian University

Evaluation of the Activity of Chronic Inflammation and Its Impact on Metabolic and Hormonal Parameters in Various PCOS Phenotypes

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study population will be characterized in terms of demographic (age, BMI), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes: A, B, C, D) will be recognized by the Rotterdam criteria. During hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Krakow, Poland, 31-501
        • Jagiellonian University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women aged 18-45, treated at the University Hospital in Krakow, diagnosed with PCOS confirmed by the Rotterdam criteria, phenotypes A, B, C, D, without other metabolic and endocrine diseases.

Description

Inclusion Criteria:

  • age 18-45 years
  • PCOS syndrome confirmed by the Rotterdam criteria

Exclusion Criteria:

  • absence of at least one ovary
  • diagnosed and/or treated other metabolic disease
  • diagnosed and/or treated other endocrine disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PCOS phenotype A
clinical and/or biochemical hyperandrogenism (HA) + ovulatory dysfunction (OD) + polycystic ovarian morphology (PCOM)
Diagnostic test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to determine and compare the above parameters of peripheral blood in the four study arms
Diagnostic test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms
PCOS phenotype B
HA + OD
Diagnostic test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to determine and compare the above parameters of peripheral blood in the four study arms
Diagnostic test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms
PCOS phenotype C
HA + PCOM
Diagnostic test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to determine and compare the above parameters of peripheral blood in the four study arms
Diagnostic test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms
PCOS phenotype D
OD + PCOM
Diagnostic test: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to determine and compare the above parameters of peripheral blood in the four study arms
Diagnostic test: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters
A venous blood sample of approximately 10 ml will be collected in the morning after 8 hours of fasting to test the above correlations in the four study arms

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes
Time Frame: up to 3 months
Measurement and comparison of leukocyte count (n/µL) in peripheral blood in the four PCOS phenotypes
up to 3 months
Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes
Time Frame: up to 3 months
Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in the four PCOS phenotypes
up to 3 months
Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes
Time Frame: up to 3 months
Measurement and comparison of concentrations of IL-1 (pg/ml) in peripheral blood in the four PCOS phenotypes
up to 3 months
Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes
Time Frame: up to 3 months
Measurement and comparison of concentrations of IL-6 (pg/ml) in peripheral blood in the four PCOS phenotypes
up to 3 months
Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes
Time Frame: up to 3 months
Measurement and comparison of concentrations of IL-10 (pg/ml) in peripheral blood in the four PCOS phenotypes
up to 3 months
Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes
Time Frame: up to 3 months
Measurement and comparison of concentrations of TNF-alpha (pg/ml) in peripheral blood in the four PCOS phenotypes
up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: leukocyte count (n/µL)
up to 3 months
Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: CRP (mg/l)
up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the HOMA-IR and inflammatory parameters: il-1 (pg/ml)
up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between HOMA-IR value and inflammatory parameters: il-6 (pg/ml)
up to 3 months
Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the concentration of HOMA-IR and inflammatory parameters: il-10 (pg/ml)
up to 3 months
Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the HOMA-IR value and inflammatory parameters: TNF-alpha (pg/ml)
up to 3 months
Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the BMI value and inflammatory parameters: leukocyte count (n/µL)
up to 3 months
Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the BMI value and inflammatory parameters: CRP (mg/l)
up to 3 months
Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the BMI and inflammatory parameters: il-1 (pg/ml)
up to 3 months
Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between BMI value and inflammatory parameters: il-6 (pg/ml)
up to 3 months
Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between BMI value and inflammatory parameters: il-10 (pg/ml)
up to 3 months
Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between the BMI value and inflammatory parameters: TNF-alpha (pg/ml)
up to 3 months
Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)
up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: CRP (mg/l)
up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-1 (pg/ml)
up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-6 (pg/ml)
up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: il-10 (pg/ml)
up to 3 months
Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AST concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)
up to 3 months
Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: leukocyte count (n/µL)
up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: CRP (mg/l)
up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-1 (pg/ml)
up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-6 (pg/ml)
up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: il-10 (pg/ml)
up to 3 months
Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between ALT concentration (U/l) and inflammatory parameters: TNF-alpha (pg/ml)
up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
up to 3 months
Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total bilirubin concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
up to 3 months
Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between total cholesterol concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: leukocyte count (n/µL)
up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: CRP (mg/l)
up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-1 (pg/ml)
up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-6 (pg/ml)
up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: il-10 (pg/ml)
up to 3 months
Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between triglycerides concentration (mg/dl) and inflammatory parameters: TNF-alpha (pg/ml)
up to 3 months
Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: leukocyte count (n/µL)
up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: CRP (mg/l)
up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-1 (pg/ml)
up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-6 (pg/ml)
up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: il-10 (pg/ml)
up to 3 months
Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes
Time Frame: up to 3 months
Evaluation of the correlation between AMH concentration (pmol/l) and inflammatory parameters: TNF-alpha (pg/ml)
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jagiellonian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Kazimierz Pityński, Prof., Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1072.6120.292.2022-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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