A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis (FEELING)

Ipsen

Status: Completed

Conditions: Endometriosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01351051

A-38-52014-185

Details and patient eligibility

About

This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.

Enrollment: 1,008 patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject is a female aged between 18 and 41 years
• The subject has undergone a laparoscopy or laparotomy for a benign gynecological indication excluding pregnancy, in the last 3 months
• The subject's surgery showed either no visible endometriosis lesions or histologically confirmed endometriosis lesions: superficial endometriosis, endometrioma or deep infiltrating endometriosis
• The subject has given a written informed consent prior to any study-related procedures

Exclusion criteria

• The subject is pregnant
• The subject's surgery results showed evidence of malignancy
• The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or with evidence of an uncooperative attitude

Trial design

1,008 participants in 4 patient groups

No endometriosis

Superficial endometriosis

Endometrioma

Deep infiltrating endometriosis