MRI-Based Prediction of Dienogest Response in Endometriosis (ESMRIDNG)

February 25, 2026 updated by: Sukhwan Hyun, Chungnam National University Sejong Hospital

Predicting the Efficacy of Dienogest in Patients With Endometriosis Using MRI

The goal of this prospective observational study is to learn whether magnetic resonance imaging (MRI) findings can help predict treatment response to dienogest in women with endometriosis. Endometriosis is a common gynecologic condition that can cause chronic pelvic pain and negatively affect quality of life. Although dienogest is widely used as a standard medical treatment, individual responses to treatment vary.

The main questions this study aims to answer are:

  • Whether baseline MRI characteristics of endometriotic lesions are associated with improvement in pelvic pain after dienogest treatment.
  • Whether MRI findings can help identify patients who are more likely to benefit from dienogest therapy.

Participants diagnosed with endometriosis who are prescribed dienogest as part of their routine clinical care will be enrolled. This study does not assign any investigational intervention. Participants will undergo standard clinical follow-up, including pelvic pain assessment using visual analog scale (VAS) scores, quality of life questionnaires, and routine MRI examinations. Clinical and imaging data will be collected prospectively and analyzed to explore imaging predictors of treatment response.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
48

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

  • South Korea
    • Sejong Special Self-Governing City
      • Sejong, Sejong Special Self-Governing City, South Korea, 30099
        • Recruiting
        • Sejong Chungnam National University Hospital
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

This study will include women aged 19 to 45 years who have been clinically diagnosed with endometriosis by an obstetrician-gynecologist. Eligible participants are those who have not received hormonal treatment within the previous 3 months and have never been treated with dienogest. All participants must provide written informed consent prior to enrollment. Patients with contraindications to dienogest, inability to undergo MRI, current or planned pregnancy within 6 months, or poor general medical condition will be excluded.

Description

Inclusion Criteria:

  • Female participants who have received a full explanation of the study and have provided written informed consent
  • Women aged 19 to 45 years who have been diagnosed with endometriosis by a board-certified obstetrician-gynecologist
  • Patients who have not received any hormonal treatment within the previous 3 months
  • Patients who have never been treated with dienogest

Exclusion Criteria:

  • Patients with a history of treatment with dienogest
  • Patients with contraindications to dienogest
  • Patients who are unable to undergo magnetic resonance imaging (MRI) (e.g., presence of metallic implants)
  • Patients who are currently pregnant or planning pregnancy within the next 6 months
  • Patients with poor general medical condition, as judged by the investigator

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

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
Change in pelvic pain severity assessed by visual analog scale.
Time Frame: Baseline to 12 months after initiation of dienogest treatment

Pelvic pain severity will be measured using the Visual Analog Scale , ranging from 0 to 10, where higher scores indicate more severe pelvic pain.

The primary outcome is the change in Visual Analog Scale score from baseline to 12 months after initiation of dienogest treatment.
Baseline to 12 months after initiation of dienogest treatment

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
Change in quality of life assessed by the Endometriosis Health Profile-30 (EHP-30)
Time Frame: Baseline to 12 months

Quality of life will be assessed using the Endometriosis Health Profile-30 (EHP-30), a validated patient-reported outcome questionnaire specific to endometriosis.

The Endometriosis Health Profile(EHP-30) core questionnaire scores range from 0 to 100, with higher scores indicating worse health-related quality of life.

The secondary outcome measure is the change in Endometriosis Health Profile(EHP-30) total score from baseline to follow-up during dienogest treatment.
Baseline to 12 months
Change From Baseline in MRI Characteristics of Endometriotic Lesions
Time Frame: Baseline to 12 months
The secondary outcome is the change from baseline in the size of endometriotic lesions measured on magnetic resonance imaging (MRI). Lesion size will be defined as the maximum diameter of the target lesion measured in millimeters on MRI at baseline and after 12 months of dienogest treatment. A reduction in lesion size indicates improvement.
Baseline to 12 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.
Chungnam National University Sejong Hospital

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.
October 14, 2025

Primary Completion (Estimated)

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.
March 1, 2027

Study Completion (Estimated)

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.
March 1, 2027

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).
February 19, 2026

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.
February 25, 2026

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 3, 2026

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.
March 3, 2026

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.
February 25, 2026

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.
January 1, 2026

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.
  • 2025-05-014

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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