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

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

Endometriosis

Study type

Observational

Funder types

Other

Identifiers

NCT06413381
ENDOFAIL - 01

Details and patient eligibility

About

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).

Enrollment

250 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No 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

Trial design

250 participants in 2 patient groups

Focus group
Description:
non-responsive patients to medical treatment
Control group
Description:
responsive patients to medical treatment

Trial contacts and locations

1

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Central trial contact

Alessandro Arena

Data sourced from clinicaltrials.gov

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