NCT06413381招募中不适用
Risk Factors for Non-response to Hormonal Medical Therapy in Patients With Endometriosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Rate of patients with endometriosis non-responsive to medical treatment at 12 months
研究概览
简要总结
Determine the proportion of patients with endometriosis unresponsive to medical therapy and to compare the clinical and ultrasonographic characteristics of this group of patients (study group) with the clinical and ultrasonographic characteristics of patients responsive to medical therapy (control group).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 50 years;
- •patients with endometriosis-related pain symptoms (dyspareunia, dyschezia, dysmenorrhea, chronic pelvic pain, dysuria, periovulatory pain, with at least one of these symptoms presenting Numerical Pain Rating Scale intensity > 5);
- •indication for administration of oral hormonal medical treatment for endometriosis;
- •acquisition of informed consent.
排除标准
- •patients with contraindications to oral hormone treatment
- •current or previous pelvic infections
- •history of malignancy or current suspicion of gynecologic malignant lesions
- •previous pelvic surgery (hysterectomy, salpingectomy, ovarian cyst removal, myomectomy, surgery for endometriosis, bowel resections)
- •positive history of other causes of chronic pelvic pain
- •post-menopausal status
结局指标
主要结局
Rate of patients with endometriosis non-responsive to medical treatment at 12 months
时间窗: 12 months
determine the rate of patients with endometriosis who were non-responsive to medical treatment at 12 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients responsive to medical treatment (control group).
次要结局
- Rate of patients with endometriosis non-responsive to medical treatment at 6 months(6 months)
研究者
研究点 (1)
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