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

Endometriosis Clinical Trial

— FEELING  

Official title:

A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351051
• Other study ID #: A-38-52014-185
• Status: Completed
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1008
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha
China	Women's Hospital School of Medicine, Zhejiang University	Zhejiang
France	Hôpital St Vincent de Paul	Paris
Russian Federation	Research Institute of Maternity and Childhood named after V.N. Gorodkov	Ivanovo
Russian Federation	Moscow Regional Scientific Research Institute of Obstetrics and Gynaecology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

China,  France,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.		Enrolment visit
Secondary	Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.		Enrolment visit
Secondary	Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.		Enrolment visit
Secondary	Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.		Enrolment visit