NCT03002870

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 years

First QC Date

October 4, 2016

Last Update Submit

September 5, 2024

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Quality of life, pain and fertility

    (QOL) endometriosis health profile (EHP-5)

    every 12 months

Study Arms (1)

Endometriosis

OTHER

Patients whom pathology results post surgery document endometriosis

Other: Questionnaires

Interventions

QuestionnairesOTHER

Patients will receive questionnaires yearly to follow their QOL

Endometriosis

Eligibility Criteria

Age13 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female patients
  • years of age
  • Anyone seen at the Center for Endometriosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Patrick Yeung, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2016

First Posted

December 26, 2016

Study Start

September 1, 2016

Primary Completion

September 4, 2024

Study Completion

September 4, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)