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临床试验/NCT06510647
NCT06510647招募中不适用

Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis.

University of Cagliari1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2024年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
247
试验地点
1
主要终点
Percentage of patients with endometriosis who are non-responsive to medical therapy after 12 months

研究概览

简要总结

The primary objective of our study is to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 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 who are responsive to medical therapy (control group).

The secondary objective of the study will be to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 6 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients who are responsive to medical therapy (control group).

详细描述

This will be an observational study without the use of medication, multicentric, prospective.

Patients aged between 18 and 50 years, with a clinical and ultrasound diagnosis of endometriosis painful symptoms related to endometriosis (dyspareunia, dyschezia, dysmenorrhea, chronic pelvic pain, dysuria, periovulatory pain, with at least one of these symptoms presenting a Numerical Pain Rating Scale intensity > 5), with an indication for hormonal therapy will be included after the acquisition of informed consent.

On the other hand, patients with contraindications to oral hormonal therapy, those with current or past pelvic infections, with a history of malignancy or current suspicion of malignant gynecological lesions, previous pelvic surgery (hysterectomy, salpingectomy, ovarian cyst removal, myomectomy, surgery for endometriosis, intestinal resections), positive history for other causes of chronic pelvic pain, or women in postmenopausal status will be excluded.

Enrollment will take place among patients who access the specialized endometriosis clinics of the Department of Gynecology and Obstetrics - Prof. Stefano Angioni, and participating centers for an initial visit. During this visit, as per clinical practice, a gynecological examination and a transvaginal gynecological ultrasound will be performed by an expert operator. In the case of an endometriosis diagnosis for which hormonal therapy is indicated and the inclusion and exclusion criteria are met, the patient will be asked to sign the informed consent for participation in the study and consent to the processing of personal data. These patients will be administered scientifically validated questionnaires at the time of the visit (time 0): Endometriosis Health Profile - 30 and the Short Form Health Survey SF - 12 ). The first is a questionnaire widely used in studies analyzing the quality of life of patients with endometriosis as it is specific to the disease, while the second is a generic quality of life questionnaire widely used in literature.

The second evaluation will be conducted 6 months later (time 1) along with a gynecological examination and gynecological ultrasound as per the normal care pathway, and the same questionnaires administered during the enrollment visit will be given again. Patients will be defined as non-responsive to medical therapy if their Endometriosis Health Profile 30 scores are equal to or higher at the "time 1" visit compared to the enrollment visit at "time 0".

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

入选标准

  • Age between 18 and 50 years;
  • Patients with painful symptoms related to endometriosis (dyspareunia, dyschezia, dysmenorrhea, chronic pelvic pain, dysuria, periovulatory pain, with at least one of these symptoms presenting a Numerical Pain Rating Scale intensity > 5);
  • Indication for the administration of oral hormonal medical therapy for endometriosis;
  • Acquisition of informed consent.

排除标准

  • Patients with contraindications to oral hormonal therapy;
  • Current or past pelvic infections;
  • History of malignancy or current suspicion of malignant gynecological lesions;
  • Previous pelvic surgery (hysterectomy, salpingectomy, ovarian cyst removal, myomectomy, surgery for endometriosis, intestinal resections);
  • Positive history for other causes of chronic pelvic pain;
  • Postmenopausal status.

结局指标

主要结局

Percentage of patients with endometriosis who are non-responsive to medical therapy after 12 months

时间窗: 12 months

To determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 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 who are responsive to medical therapy (control group).

次要结局

  • Percentage of patients with endometriosis who are non-responsive to medical therapy after 6 months(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Angioni

Full Professor of Gynecology and Obstetrics

University of Cagliari

研究点 (1)

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