Identifying factors affecting hormonal treatment response in endometriosis patients
Risk Factors for Non-response to Hormonal Medical Therapy in Patients With Endometriosis
This study is trying to find out why some women with endometriosis don’t respond to hormonal treatments by looking at their symptoms and ultrasound results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06413381 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the proportion of patients with endometriosis who do not respond to hormonal medical therapy. It will compare the clinical and ultrasonographic characteristics of patients who are unresponsive to treatment with those who are responsive. By analyzing these characteristics, the study seeks to identify potential risk factors associated with non-response to therapy. The findings could help tailor treatment strategies for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 50 with endometriosis-related pain symptoms and an indication for hormonal treatment.
Not a fit: Patients with contraindications to hormone treatment or those with a history of malignancy or pelvic infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with endometriosis, enhancing their quality of life.
How similar studies have performed: While this study focuses on a specific aspect of endometriosis treatment response, similar studies have shown promise in identifying risk factors for treatment non-response in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, BO
- IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola — Bologna, Bo, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Arena
- Email: alessandro.arena6@unibo.it
- Phone: +390512144385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.