Endometriosis, Ovarian
Conditions
Keywords
dienogest, MRI, Observational study
Brief summary
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.
Interventions
None listed
Sponsors
Chungnam National University Sejong Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pelvic pain severity assessed by visual analog scale. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life assessed by the Endometriosis Health Profile-30 (EHP-30) | 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. |
| Change From Baseline in MRI Characteristics of Endometriotic Lesions | 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. |
Countries
South Korea
Outcome results
None listed