Predicting the Efficacy of Dienogest in Patients With Endometriosis Using MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in pelvic pain severity assessed by visual analog scale.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in pelvic pain severity assessed by visual analog scale.
时间窗: 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.
次要结局
- Change in quality of life assessed by the Endometriosis Health Profile-30 (EHP-30)(Baseline to 12 months)
- Change From Baseline in MRI Characteristics of Endometriotic Lesions(Baseline to 12 months)
研究者
Sukhwan Hyun
Assistant Clinical Professor, Department of Obstetrics and Gynecology
Chungnam National University Sejong Hospital