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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01351051
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):

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
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 2011
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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. [ Time Frame: Enrolment visit ]

Secondary Outcome Measures :
  1. Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ]
  2. Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ]
  3. Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women who have undergone a laparoscopy/laparatomy for a benign gynaecological indication excluding pregnancy in the last 3 months.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351051


Locations
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, China
France
Hôpital St Vincent de Paul
Paris, France
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, Russian Federation
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Patrick Cabri, M.D. Ipsen
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01351051     History of Changes
Other Study ID Numbers: A-38-52014-185
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female