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NCT Number: NCT06414720

Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Progesterone Resistance Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Udine

Udine, UD, 33100, Italy

Location status: Recruiting

Location contact

Anna Biasioli, dr

CONTACT

[email protected]

Daniela Cesselli, prof

SUB_INVESTIGATOR

Matilde Degano, dr

CONTACT

[email protected]

3206173076 ext. 0039

Michela Bulfoni, dr

SUB_INVESTIGATOR

About this study

In recent years, scientific literature has focused on the search for new non-invasive diagnostic tools that can identify patients with endometriosis early and easily, thereby reducing diagnostic delay and enabling the immediate initiation of appropriate treatment. Among these, microRNA (miRNA) is emerging as a promising option. Despite recent progress in this field, a predictive biomarker of response to medical therapy or vice versa, resistance to progesterone in endometriosis, has not yet been identified, including among miRNAs. This study aims, therefore, to identify salivary miRNA signatures specific to endometriosis and differentially expressed between responder and non-responder patients to 2 mg dienogest medical therapy. 90 patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine will be enrolled. The investigators will ask them for a salivary sample before starting the progestin therapy. After 4 months from the beginning, the response will be evaluated. The researchers will evaluate the differences between salivary miRNA of the responders vs non-responders.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dienogest 2 MG

Drug

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

Other names: zafrilla, devicius, endodien, visanne

Primary outcomes

  1. response to the progestin therapy

    Time frame: 0 (pre-therapy) - 4 months (after therapy)

    response to 2 mg dienogest therapy evaluated with NRS (numeric rating scale) scale assessed for acyclic pain, dyspareunia, dyschezia, dysmenorrhea, periovulatory pain

  2. changes in quality of life

    Time frame: 0 (pre-therapy) - 4 months (after therapy)

    changes in quality of life assessed with questionnaire SF-36 (Short Form Health Survey 36)

  3. differences in salivary miRNoma

    Time frame: sample collection at time 0, analysis after time 4

    Once it is established which patients are responders and which are non-responders, differential salivary miRNAs between the two groups will be identified via sequencing. The miRNA reverse transcription reaction will be performed using the reverse transcription kit TaqMan MicroRNA (Applied Biosystems). The reverse transcription product will be used for Real-time PCR. The small nucleolar RNA RNU6 will be used as an endogenous control. The protocol of Amplification will be carried out using the LightCycler 480 instrument (Roche). For each miRNA, qPCR will be performed in duplicate. The relative expression levels of miRNAs will be calculated using the 2-ΔΔCt method.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Biasioli, dr

CONTACT

[email protected]

Matilde Degano, dr

CONTACT

[email protected]

3206173076 ext. 0039

Sponsors and collaborators

Lead sponsor

University of Udine

Other

Registry information

Official study title

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

Acronym: ENDOmiRNA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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