RISK FACTORS FOR NON-RESPONSE TO HORMONAL MEDICAL THERAPY IN PATIENTS WITH ENDOMETRIOSIS

Endometriosis Clinical Trial

Official title:

RISK FACTORS FOR NON-RESPONSE TO HORMONAL MEDICAL THERAPY IN PATIENTS WITH ENDOMETRIOSIS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06413381
• Other study ID #: ENDOFAIL - 01
• Status: Recruiting
• Start date: April 19, 2024
• Est. completion date: November 28, 2029

Study information

• Verified date: March 2024
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Alessandro Arena
• Phone: +390512144385
• Email: alessandro.arena6[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 28, 2029
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with endometriosis non-responsive to medical treatment at 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).	12 months
Secondary	Rate of patients with endometriosis non-responsive to medical treatment at 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).	6 months