Analyzing salivary microRNA in endometriosis patients and their response to progestin therapy
Salivary MicroRNA in Endometriosis: Correlation With Progestin Treatment Response: A Prospective Observational Study
This study is testing if analyzing saliva can help identify which women with endometriosis will respond well to a specific hormone treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Udine Academic / other |
| Locations | 1 site (Udine, UD) |
| Trial ID | NCT06414720 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the salivary microRNA profiles of patients diagnosed with endometriosis to determine differences between those who respond to progestin therapy and those who do not. Ninety patients attending the Chronic Pelvic Pain Clinic will provide saliva samples before starting treatment with 2 mg dienogest. After four months of therapy, the researchers will evaluate the treatment response and analyze the salivary miRNA signatures to identify potential biomarkers for therapy response. The goal is to enhance non-invasive diagnostic tools for early identification and treatment of endometriosis.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years of age with a clinical or histological diagnosis of endometriosis who are not currently undergoing progestin therapy.
Not a fit: Patients who are pregnant, pre-menopausal, post-menopausal, or have conditions affecting salivary miRNA measurement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a non-invasive biomarker for predicting treatment response in endometriosis patients.
How similar studies have performed: While there has been progress in identifying biomarkers for endometriosis, this specific approach using salivary miRNA profiles is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * Age \> 18 years * Fertile age * Clinical-ultrasound diagnosis or histological diagnosis of endometriosis * Informed consent EXCLUSION CRITERIA * Pregnancy * Pre-menarcheal or post-menopausal status * Chronic pelvic pain syndrome with or without central sensitization assessed with the Central Sensitization Inventory Test (CSI) * Neoplasia, diabetes, BMI \> 30 kg/m2, coagulopathies, autoimmune diseases, or other conditions that may affect salivary miRNA measurement * Currently undergoing progestin therapy
Where this trial is running
Udine, UD
- University of Udine — Udine, Ud, Italy (Recruiting)
Study contacts
- Study coordinator: Matilde Degano, dr
- Email: matildedegano@rocketmail.com
- Phone: 3206173076
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.