Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510647
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Risk Factors for Hormonal Therapy Failure in Patients With Endometriosis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDOFAIL-01
Brief Summary:
The primary objective of our study is to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 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 who are responsive to medical therapy control group
The secondary objective of the study will be to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 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 who are responsive to medical therapy control group
The secondary objective of the study will be to determine the percentage of patients with endometriosis who are non-responsive to medical therapy after 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 who are responsive to medical therapy control group
Detailed Description:
This will be an observational study without the use of medication multicentric prospective
Patients aged between 18 and 50 years with a clinical and ultrasound diagnosis of endometriosis painful symptoms related to endometriosis dyspareunia dyschezia dysmenorrhea chronic pelvic pain dysuria periovulatory pain with at least one of these symptoms presenting a Numerical Pain Rating Scale intensity 5 with an indication for hormonal therapy will be included after the acquisition of informed consent
On the other hand patients with contraindications to oral hormonal therapy those with current or past pelvic infections with a history of malignancy or current suspicion of malignant gynecological lesions previous pelvic surgery hysterectomy salpingectomy ovarian cyst removal myomectomy surgery for endometriosis intestinal resections positive history for other causes of chronic pelvic pain or women in postmenopausal status will be excluded
Enrollment will take place among patients who access the specialized endometriosis clinics of the Department of Gynecology and Obstetrics - Prof Stefano Angioni and participating centers for an initial visit During this visit as per clinical practice a gynecological examination and a transvaginal gynecological ultrasound will be performed by an expert operator In the case of an endometriosis diagnosis for which hormonal therapy is indicated and the inclusion and exclusion criteria are met the patient will be asked to sign the informed consent for participation in the study and consent to the processing of personal data These patients will be administered scientifically validated questionnaires at the time of the visit time 0 Endometriosis Health Profile - 30 and the Short Form Health Survey SF - 12 The first is a questionnaire widely used in studies analyzing the quality of life of patients with endometriosis as it is specific to the disease while the second is a generic quality of life questionnaire widely used in literature
The second evaluation will be conducted 6 months later time 1 along with a gynecological examination and gynecological ultrasound as per the normal care pathway and the same questionnaires administered during the enrollment visit will be given again Patients will be defined as non-responsive to medical therapy if their Endometriosis Health Profile 30 scores are equal to or higher at the time 1 visit compared to the enrollment visit at time 0
Patients will then be re-evaluated as per normal clinical practice 12 months time 2 after the first visit again through a gynecological examination and gynecological ultrasound and the two aforementioned questionnaires will be administered once more Similarly patients with EHP-30 scores equal to or higher than the previous control at time 1 will be defined as non-responsive to medical therapy
The study will be discontinued for patients who at the first follow-up visit show EHP-30 scores lower than the previous control therefore considered responsive but who request to discontinue or switch therapy due to side effects deemed disabling These patients will only be included in the analysis related to the 6-month outcome objective their characteristics will be examined through descriptive analysis and an attrition analysis with logistic regression will be conducted to identify variables potentially associated with dropping out of the study
At Times 0 1 and 2 the following parameters will be recorded
Age BMI parity comorbidities pain symptoms endometriosis-related pain score characteristics of bowel habits and urination locations and characteristics of endometriotic lesions type of hormonal therapy
Results of the administered questionnaires
The total duration of the study will be 5 years and 7 months divided as follows
Enrollment 52 months
Minimum follow-up 12 months
Data analysis 3 months
Patients aged between 18 and 50 years with a clinical and ultrasound diagnosis of endometriosis painful symptoms related to endometriosis dyspareunia dyschezia dysmenorrhea chronic pelvic pain dysuria periovulatory pain with at least one of these symptoms presenting a Numerical Pain Rating Scale intensity 5 with an indication for hormonal therapy will be included after the acquisition of informed consent
On the other hand patients with contraindications to oral hormonal therapy those with current or past pelvic infections with a history of malignancy or current suspicion of malignant gynecological lesions previous pelvic surgery hysterectomy salpingectomy ovarian cyst removal myomectomy surgery for endometriosis intestinal resections positive history for other causes of chronic pelvic pain or women in postmenopausal status will be excluded
Enrollment will take place among patients who access the specialized endometriosis clinics of the Department of Gynecology and Obstetrics - Prof Stefano Angioni and participating centers for an initial visit During this visit as per clinical practice a gynecological examination and a transvaginal gynecological ultrasound will be performed by an expert operator In the case of an endometriosis diagnosis for which hormonal therapy is indicated and the inclusion and exclusion criteria are met the patient will be asked to sign the informed consent for participation in the study and consent to the processing of personal data These patients will be administered scientifically validated questionnaires at the time of the visit time 0 Endometriosis Health Profile - 30 and the Short Form Health Survey SF - 12 The first is a questionnaire widely used in studies analyzing the quality of life of patients with endometriosis as it is specific to the disease while the second is a generic quality of life questionnaire widely used in literature
The second evaluation will be conducted 6 months later time 1 along with a gynecological examination and gynecological ultrasound as per the normal care pathway and the same questionnaires administered during the enrollment visit will be given again Patients will be defined as non-responsive to medical therapy if their Endometriosis Health Profile 30 scores are equal to or higher at the time 1 visit compared to the enrollment visit at time 0
Patients will then be re-evaluated as per normal clinical practice 12 months time 2 after the first visit again through a gynecological examination and gynecological ultrasound and the two aforementioned questionnaires will be administered once more Similarly patients with EHP-30 scores equal to or higher than the previous control at time 1 will be defined as non-responsive to medical therapy
The study will be discontinued for patients who at the first follow-up visit show EHP-30 scores lower than the previous control therefore considered responsive but who request to discontinue or switch therapy due to side effects deemed disabling These patients will only be included in the analysis related to the 6-month outcome objective their characteristics will be examined through descriptive analysis and an attrition analysis with logistic regression will be conducted to identify variables potentially associated with dropping out of the study
At Times 0 1 and 2 the following parameters will be recorded
Age BMI parity comorbidities pain symptoms endometriosis-related pain score characteristics of bowel habits and urination locations and characteristics of endometriotic lesions type of hormonal therapy
Results of the administered questionnaires
The total duration of the study will be 5 years and 7 months divided as follows
Enrollment 52 months
Minimum follow-up 12 months
Data analysis 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None