Risk Factors for Non-response to Hormonal Medical Therapy in Patients With Endometriosis

Recruiting

• Conditions: Endometriosis

• Registration Number: NCT06413381
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-04-19
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-14
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2028-08-31
• Study Completion: 2029-11-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of patients with endometriosis non-responsive to medical treatment at 12 months	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).

Secondary Outcome Measures

Name	Time	Method
Rate of patients with endometriosis non-responsive to medical treatment at 6 months	6 months	determine the rate of patients with endometriosis who were non-responsive to medical treatment at 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 responsive to medical treatment (control group).

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola; 🇮🇹 Bologna, BO, Italy