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

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: Recruiting
• Conditions: Endometriosis, Ovarian

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

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: Sukhwan Hyun, MD, PhD; Phone Number: +82-44-995-4724; Email: neo1714@cnuh.co.kr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pelvic pain severity assessed by visual analog scale.	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

Outcome Measure	Measure Description	Time Frame
Change in quality of life assessed by the Endometriosis Health Profile-30 (EHP-30)	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	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

• Sponsor: Chungnam National University Sejong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: MRI; Observational study; dienogest
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID 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