EndometriosisENDOmiRNANCT06414720
Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy
An observational study of Endometriosis, run by University of Udine at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Dienogest 2 MG
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: All the patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who meet the inclusion criteria.
Who may be able to join
- Age > 18 years
- Fertile age
- Clinical-ultrasound diagnosis or histological diagnosis of endometriosis
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Biasioli, dr contact
Italy1 site, 1 recruiting
- Recruiting
University of Udine
Udine, UD, 33100
Matilde Degano, dr, 3206173076 ext. 0039, matildedegano@rocketmail.com
Anna Biasioli, dr, anna.biasioli@asufc.sanita.fvg.it
About this study
Official title: Salivary MicroRNA in Endometriosis: Correlation With Progestin Treatment Response: A Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Endometriosis
- Being tested
- Dienogest 2 MG
- Keywords
- Endometriosis, miRNA, Progesterone resistance
- Medical subject headings
- Endometriosis, Progesterone Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest 2 MGDrug
Also called zafrilla, devicius, endodien, visanne
The patients will be started on progestin therapy after a saliva sample is collected from them for miRNA analysis.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis patients | Patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who have not yet started medical therapy. Receives: Drug: Dienogest 2 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to the progestin therapy
response to 2 mg dienogest therapy evaluated with NRS (numeric rating scale) scale assessed for acyclic pain, dyspareunia, dyschezia, dysmenorrhea, periovulatory pain
Measured: 0 (pre-therapy) - 4 months (after therapy)
changes in quality of life
changes in quality of life assessed with questionnaire SF-36 (Short Form Health Survey 36)
Measured: 0 (pre-therapy) - 4 months (after therapy)
differences in salivary miRNoma
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.
Measured: sample collection at time 0, analysis after time 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start22 Apr 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Vizzielli, University of Udine
- Investigators
- Giuseppe Vizzielli, prof, Study chair, University of Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414720
- Sponsor's protocol ID
- ENDOmiRNA
- Acronym
- ENDOmiRNA
- Status last verified
- Mar 2025
- First submitted
- 5 May 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bendifallah S, Suisse S, Puchar A, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Bouteiller D, Touboul C, Dabi Y, Darai E. Salivary MicroRNA Signature for Diagnosis of Endometriosis. J Clin Med. 2022 Jan 26;11(3):612. doi: 10.3390/jcm11030612.
PubMed 35160066Zhang P, Wang G. Progesterone Resistance in Endometriosis: Current Evidence and Putative Mechanisms. Int J Mol Sci. 2023 Apr 10;24(8):6992. doi: 10.3390/ijms24086992.
PubMed 37108154Hon JX, Wahab NA, Karim AKA, Mokhtar NM, Mokhtar MH. MicroRNAs in Endometriosis: Insights into Inflammation and Progesterone Resistance. Int J Mol Sci. 2023 Oct 9;24(19):15001. doi: 10.3390/ijms241915001.
PubMed 37834449
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary MicroRNA in Endometriosis: Correlation With Progestin Treatment Response: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06414720
- Acronym / sponsor ID
- ENDOmiRNA / ENDOmiRNA
- Conditions
- Endometriosis
- Keywords
- Endometriosis, miRNA, Progesterone resistance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of UdineUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometriosis patients | – | Drug: Dienogest 2 MGPatients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who have not yet started medical therapy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All the patients diagnosed with endometriosis attending the Obstetrics and Gynecology Clinic at the Santa Maria della Misericordia Hospital in Udine, who meet the inclusion criteria.
Key inclusion criteria (4 listed)
- Age > 18 years
- Fertile age
- Clinical-ultrasound diagnosis or histological diagnosis of endometriosis
- Informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dienogest 2 MGAlso: zafrilla, devicius, endodien, visanneThe patients will be started on progestin therapy after a saliva sample is collected from them for miRNA analysis. | Drug | Endometriosis patients |
Primary outcome
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
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 35160066Bendifallah S, Suisse S, Puchar A, Delbos L, Poilblanc M, Descamps P, Golfier F, Jornea L, Bouteiller D, Touboul C, Dabi Y, Darai E. Salivary MicroRNA Signature for Diagnosis of Endometriosis. J Clin Med. 2022 Jan 26;11(3):612. doi: 10.3390/jcm11030612.
- Background: PubMed 37108154Zhang P, Wang G. Progesterone Resistance in Endometriosis: Current Evidence and Putative Mechanisms. Int J Mol Sci. 2023 Apr 10;24(8):6992. doi: 10.3390/ijms24086992.
- Background: PubMed 37834449Hon JX, Wahab NA, Karim AKA, Mokhtar NM, Mokhtar MH. MicroRNAs in Endometriosis: Insights into Inflammation and Progesterone Resistance. Int J Mol Sci. 2023 Oct 9;24(19):15001. doi: 10.3390/ijms241915001.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Biasioli, dr contact
Giuseppe Vizzielli, prof study chair
University of Udine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University of Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matilde Degano, dr (3206173076 ext. 0039, matildedegano@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response to the progestin therapy (time frame: 0 (pre-therapy) - 4 months (after therapy)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06414720, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.