Identifying factors affecting hormonal treatment response in endometriosis patients
Official title: Risk Factors for Non-response to Hormonal Medical Therapy in Patients With Endometriosis
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06413381 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | April 19, 2024 |
| Main results expected | August 31, 2028 |
| Study ends | November 28, 2029 |
| Registry record updated | August 1, 2024 |
| Trial ID | NCT06413381 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 to 50 with endometriosis-related pain symptoms and an indication for hormonal treatment.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola
Bologna, Bo, Italy Recruiting
Study contacts
- Study coordinator: Alessandro Arena
- Email: alessandro.arena6@unibo.it
- Phone: +390512144385
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
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Postoperative Pain Trajectories After Endometriosis Surgery
This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.
-
Imaging endometriosis with a special PET tracer in adult women
This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.
-
Fiber supplement for digestive symptoms in endometriosis
A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.
-
Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy
The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.
-
Atypical Endometriosis: Histology, Immunophenotype and Molecular Features
Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.