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

Ipsen7 sites in 3 countries1,008 target enrollmentMay 2011

ConditionsEndometriosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endometriosis
Sponsor: Ipsen
Enrollment: 1008
Locations: 7
Primary Endpoint: Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

April 2013

Last Updated

7 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire.

Time Frame: Enrolment visit

Secondary Outcomes

Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire.(Enrolment visit)
Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire.(Enrolment visit)
Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire.(Enrolment visit)