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Clinical Trials in Italy / NCT06413381
Recruiting Observational

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

NCT06413381 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2024-04-19
Last updated
2024-08-01

Condition(s) studied

Endometriosis

Study 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

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of patients with endometriosis non-responsive to medical treatment at 12 months — 12 months
    determine the rate of patients with endometriosis who were non-responsive to medical treatment at 12 months and to compare the clinical and ultrasound characteristics of this group of patients (study group) with the clinical and ultrasound characteristics of patients responsive to medical treatment (control group).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Bologna BO Recruiting

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Other trials for the same condition

Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis Recruiting
AAGL 2021 Classification and Surgical Complications in Women With Endometriosis Starting soon
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF Recruiting
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery Starting soon
Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06413381 on ClinicalTrials.gov ↗ ← All trials in Italy