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

NCT ID: NCT06413381

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-19

Study Completion Date

2029-11-28

Brief Summary

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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).

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Focus group

non-responsive patients to medical treatment

No interventions assigned to this group

Control group

responsive patients to medical treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Arena

Role: CONTACT

+390512144385

Facility Contacts

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Alessandro Arena, MD

Role: primary

+390512144385

Other Identifiers

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ENDOFAIL - 01

Identifier Type: -

Identifier Source: org_study_id

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