Trial record 11 of 196 for:    endometriosis

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01351051
First received: April 8, 2011
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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
Endometriosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ] [ Designated as safety issue: No ]
  • Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ] [ Designated as safety issue: No ]
  • Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire. [ Time Frame: Enrolment visit ] [ Designated as safety issue: No ]

Enrollment: 1008
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No endometriosis
Superficial endometriosis
Endometrioma
Deep infiltrating endometriosis

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01351051     History of Changes
Other Study ID Numbers: A-38-52014-185
Study First Received: April 8, 2011
Last Updated: May 29, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés
Russia: Ethics Committee
China: Ethics Committee

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014