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NCT Number: NCT07446608

MRI-Based Prediction of Dienogest Response in Endometriosis

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.

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Key information

Conditions

Endometriosis, Ovarian Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

19 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Sejong Chungnam National University Hospital

Sejong, Sejong Special Self-Governing City, 30099, South Korea

Location status: Recruiting

Location contact

Sukhwan Hyun, MD, PhD

CONTACT

[email protected]

+82-44-995-4724

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Chungnam National University Sejong Hospital

Other

Registry information

Official study title

Predicting the Efficacy of Dienogest in Patients With Endometriosis Using MRI

Acronym: ESMRIDNG

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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