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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06413381

Enrollment

250

Registered

2024-05-14

Start date

2024-04-19

Completion date

2029-11-28

Last updated

2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

pelvic pain, endometriosis, hormone therapy, therapeutic non-response, risk factors, reproduction, infertility

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Secondary

Measure	Time frame	Description
Rate of patients with endometriosis non-responsive to medical treatment at 6 months	6 months	determine the rate of patients with endometriosis who were non-responsive to medical treatment at 6 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).

Countries

Italy

Contacts

Primary ContactAlessandro Arena

alessandro.arena6@unibo.it+390512144385

Outcome results