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Recruiting NCT06413381

NCT06413381 Risk Factors for Non-response to Hormonal Medical Therapy in Patients With Endometriosis

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Clinical Trial Summary
NCT ID NCT06413381
Status Recruiting
Phase
Sponsor IRCCS Azienda Ospedaliero-Universitaria di Bologna
Condition Endometriosis
Study Type OBSERVATIONAL
Enrollment 250 participants
Start Date 2024-04-19
Primary Completion 2028-08-31

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 50 Years
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 250 participants in total. It began in 2024-04-19 with a primary completion date of 2028-08-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Determine the proportion of patients with endometriosis unresponsive to medical therapy and to compare the clinical and ultrasonographic characteristics of this group of patients (study group) with the clinical and ultrasonographic characteristics of patients responsive to medical therapy (control group).

Eligibility 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

Contact & Investigator

Central Contact

Alessandro Arena

✉ alessandro.arena6@unibo.it

📞 +390512144385

Frequently Asked Questions

Who can join the NCT06413381 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06413381 currently recruiting?

Yes, NCT06413381 is actively recruiting participants. Contact the research team at alessandro.arena6@unibo.it for enrollment information.

Where is the NCT06413381 trial being conducted?

This trial is being conducted at Bologna, Italy.

Who is sponsoring the NCT06413381 clinical trial?

NCT06413381 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 250 participants.

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