Recruiting NCT06413381
Risk Factors for Non-response to Hormonal Medical Therapy in Patients With Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Primary outcome measures
- Rate of patients with endometriosis non-responsive to medical treatment at 12 months [Time frame: 12 months]
Secondary outcome measures (1)
- Rate of patients with endometriosis non-responsive to medical treatment at 6 months [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola — Bologna
Identifiers
NCT: NCT06413381 · ENDOFAIL - 01