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

• Sponsor: Ipsen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01351051
• Collaborator: (none)
• Enrollment: 1,008
• Locations: 7
• Duration (Months): 23
• Patients Per Site: 144
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis

Study Design

• Study Type: Observational
• Actual Enrollment: 1008 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No endometriosis
Superficial endometriosis
Endometrioma
Deep infiltrating endometriosis

Outcome Measures

Primary Outcome Measures

1. Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire. [Enrolment visit]

Secondary Outcome Measures

1. Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire. [Enrolment visit]

2. Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire. [Enrolment visit]

3. Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire. [Enrolment visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 41 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT01351051
• Other Study ID Numbers: A-38-52014-185
• First Posted: May 10, 2011
• Last Update Posted: Jan 14, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Jan 14, 2019