- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04440397
Relationship Between Endoplasmic Reticulum Stress and Pain in Patients With Endometriosis
August 5, 2020 updated by: Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
Endoplasmic Reticulum Stress and Endometriosis Releated Pain
The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis.
For this, xbp-1 (x box binding protein-1) level was measured in patients.
XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain pathogenesis.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and ultrasound, without known rheumatological or metabolic diseases were included in the study.
Most of the patients are composed of newly diagnosed patients.
Study Type
Observational
Enrollment (Actual)
86
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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İ̇stanbul
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Istanbul, İ̇stanbul, Turkey, 34000
- Pinar Yalcin Bahat
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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
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Women between the ages of 18-50 who were diagnosed with endometriosis by ultrasound or surgery and who did not have any rheumatological and metaboli disease were included in the study.
women with drug use indicated in the last 3 months were excluded from the study.
Description
Inclusion Criteria:
- diagnosed endometriosis with ultrasound or surgery
- no metabolic diseases
- no rheumatological diseases
Exclusion Criteria:
- Immune modulator, hormonal, anti-inflammatory use history in the last 3 months
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis.
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum XBP-1levels in patients wit endometriosis
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 17, 2020
Primary Completion (ACTUAL)
August 1, 2020
Study Completion (ACTUAL)
August 4, 2020
Study Registration Dates
First Submitted
June 17, 2020
First Submitted That Met QC Criteria
June 17, 2020
First Posted (ACTUAL)
June 19, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 7, 2020
Last Update Submitted That Met QC Criteria
August 5, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- xbpendo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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