## Protocol Section
### Identification Module
**NCT ID:** NCT06413381

**Brief Title:** RISK FACTORS FOR NON-RESPONSE TO HORMONAL MEDICAL THERAPY IN PATIENTS WITH ENDOMETRIOSIS

**Official Title:** RISK FACTORS FOR NON-RESPONSE TO HORMONAL MEDICAL THERAPY IN PATIENTS WITH ENDOMETRIOSIS

#### Organization Study ID Info
**ID:** ENDOFAIL - 01
#### Organization
**Class:** OTHER
**Full Name:** IRCCS Azienda Ospedaliero-Universitaria di Bologna
### Status Module
#### Completion Date
**Date:** 2029-11-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-19

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** IRCCS Azienda Ospedaliero-Universitaria di Bologna

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Endometriosis

**Keywords:**

- pelvic pain

- endometriosis

- hormone therapy

- therapeutic non-response

- risk factors

- reproduction

- infertility

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 250

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** non-responsive patients to medical treatment

**Label:** Focus group

#### Arm Group 2

**Description:** responsive patients to medical treatment

**Label:** Control group

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Rate of patients with endometriosis non-responsive to medical treatment at 12 months

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** 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).

**Measure:** Rate of patients with endometriosis non-responsive to medical treatment at 6 months

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Patients with clinical and ultrasound diagnosis of endometriosis with indication for administration of hormone therapy

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alessandro.arena6@unibo.it

**Name:** Alessandro Arena

**Phone:** +390512144385

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bologna

**Contacts:**

***Contact 1:***

- **Email:** alessandro.arena6@unibo.it

- **Name:** Alessandro Arena, MD

- **Phone:** +390512144385

- **Role:** CONTACT

***Contact 2:***

- **Name:** Renato Seracchioli, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Alessandro Arena, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Italy

**Facility:** IRCCS Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola

**State:** BO

**Status:** RECRUITING

**Zip:** 40138

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M19918

- Name: Pelvic Pain

- Relevance: LOW

- As Found: Unknown

- ID: M7877

- Name: Endometriosis

- Relevance: HIGH

- As Found: Endometriosis

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004715

- Term: Endometriosis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
