Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis.

ConditionEndometriosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-50

SponsorUniversity of Cagliari

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial population

Patients with a clinical and ultrasound diagnosis of endometriosis with an indication for hormonal therapy.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Hormonal Therapy Agent
Other intervention
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.

Treatment groups

247 Participants

are divided into 2 treatment groups

Group A: Group A1 intervention

Group B: Group B1 intervention

Trial outcomes

Primary outcomes

Percentage of patients with endometriosis who are non-responsive to medical therapy after 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).

Time frame

12 months

Secondary outcomes

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

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).

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cagliari

Lead sponsor

Source ClinicalTrials.gov

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