Clinical trial

Salivary MicroRNA in Endometriosis: Correlation With Progestin Treatment Response: A Prospective Observational Study

Name

ENDOmiRNA

Description

This study aims to analyze the salivary miRNA specific for patients diagnosed with endometriosis, specifically evaluating the miRNA profile of patients who respond versus those who do not respond to progestin therapy. Ninety patients attending the Chronic Pelvic Pain Clinic will be recruited, and they will be asked to provide a saliva sample before starting medical therapy. The response to the therapy will be evaluated after 4 months from the beginning of the therapy itself.

Trial arms

Trial start

2024-04-22

Estimated PCD

2025-01-01

Trial end

2025-05-01

Status

Recruiting

Treatment

Dienogest 2 MG

The patients will be started on progestin therapy after a saliva sample is collected from them for miRNA analysis.

Arms:

Endometriosis patients

Other names:

zafrilla, devicius, endodien, visanne

Size

Primary endpoint

response to the progestin therapy

0 (pre-therapy) - 4 months (after therapy)

changes in quality of life

0 (pre-therapy) - 4 months (after therapy)

differences in salivary miRNoma

sample collection at time 0, analysis after time 4

Eligibility 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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'salivary specimen'}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2024-05-16

1 organization

1 product

1 indication

Organization

University of Udine

Product

Dienogest

Indication

Endometriosis