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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:
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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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sejong Chungnam National University Hospital | Recruiting | Sejong | Sejong Special Self-Governing City | 30099 | South Korea |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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 |
| D000091662 | Genital Diseases |