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NCT03002870 Clinical Trial

Characteristics of Patient Population With Endometriosis

Endometriosis Clinical Trial

— 20900  

Official title:
Characteristics of Patient Population With Endometriosis - A Prospective Database and BioBank

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03002870
Other study ID # 20900
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date September 2025

Study information
Verified date August 2023
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to collect and analyze data on the characteristics of women who are seeking treatment for endometriosis, suspected endometriosis, pain and/or infertility as part of their standard medical care. Data collected will contribute to the development of guidelines for the surgical management of endometriosis. In addition, specimens will be collected for future testing regarding diagnosing, and/or staging of endometriosis, or suspected endometriosis, pain and infertility.

Description:

Patients seen at Saint Louis University Center for Endometriosis (which has offices locations at St. Mary's, St. Luke's and the SLU-UMG clinic - all of which are in the SLU Epic system), and operated on for endometriosis, suspected endometriosis, pain and/or infertility at St. Mary's hospital (only). A preoperative questionnaire will be provided to the subject. Questions from the survey include information on baseline demographics, severity and type of pain, and previous medical and surgical history. Operative data will also be collected and analyzed. A post-operative questionnaire will be administered to the participants at 6 months, and then at regular yearly intervals after the surgery by a secure on-line process using the RedCap software. Improvement in quality of life and pain scores will be analyzed. Specimens will also be collected and stored for future testing regarding diagnosing, and/or staging of endometriosis, suspected endometriosis, pain and infertility.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 55 Years
Eligibility Inclusion Criteria: - Female patients - 13-55 years of age - Anyone seen at the Center for Endometriosis Exclusion Criteria: - Prior bilateral salpingo-oophorectomy - post natural menopause - Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaires
Patients will receive questionnaires yearly to follow their QOL

Locations
Country Name City State
United States Saint Louis University Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life, pain and fertility (QOL) endometriosis health profile (EHP-5) every 12 months
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