MRI-Based Prediction of Dienogest Response in Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometriosis, Ovarian. Basic parameters: 19 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predicting the Efficacy of Dienogest in Patients With Endometriosis Using MRI
Overview
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.
Primary outcome measures
- Change in pelvic pain severity assessed by visual analog scale. [Time frame: Baseline to 12 months after initiation of dienogest treatment]
Secondary outcome measures (2)
- Change in quality of life assessed by the Endometriosis Health Profile-30 (EHP-30) [Time frame: Baseline to 12 months]
- Change From Baseline in MRI Characteristics of Endometriotic Lesions [Time frame: Baseline to 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Sejong Chungnam National University Hospital — Sejong
Identifiers
NCT: NCT07446608 · 2025-05-014