MedTrace Logo

Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis.

NCT06510647 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 247

Last updated 2024-07-19

No results posted yet for this study

Summary

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).

Conditions

  • Endometriosis

Interventions

OTHER

Hormonal Therapy Agent

With an endometriosis diagnosis in which hormonal therapy is indicated, patients who satisfy inclusion and exclusion criteria 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 second evaluation will be conducted 6 months later (time 1) along with a gynecological examination and gynecological ultrasound, and the same two questionnaires will be administered. 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". Patients will then be re-evaluated 12 months (time 2) after the first visit with the same criteria, and the two questionnaires will be administered once more. Similarly, patients with EHP-30 scores equal to or higher than the previous control at time 1 will be defined as non-responsive to medical therapy.

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2025-07-01
Completion
2026-05-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510647 on ClinicalTrials.gov