NCT03744377

Brief Summary

Endometriosis can affect quality of life, including physical, psychological and social aspects. It is important to include quality of life measures in evaluating disease severity and response to any given treatment. The 30-item Endometriosis Health Profile (EHP-30) from in-depth interviews with patients with endometriosis is currently the most reliable questionnaire for the measurement of health-related quality of life in women with endometriosis. It includes specific questions addressing the problems faced by patients with endometriosis. The aim of the present study is to validate the Turkish version of EPH 30, a self reported questionnaiere already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

November 14, 2018

Last Update Submit

November 14, 2018

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Validation of Endometriosis health profile-30 (EHP-30) Turkish version

    internal consistency and construct validity

    baseline

Interventions

The Endometriosis Health Profile EPH-30OTHER

Self-reported questionnaires

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women referred to Obstetrics and Gynecological Department for the treatment of endometriosis.

You may qualify if:

  • Previous surgical and histological diagnosis of endometriosis

You may not qualify if:

  • Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
  • Psychiatric diseases
  • Refusal or inability to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Hospital

Istanbul, 34365, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mehmet Ceyhan, MD

CONTACT

+905426239426mceyhan85@hotmail.com

Mehmet Ceyhan

CONTACT

mceyhan85@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrician and gynecologist

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Study Start

November 15, 2018

Primary Completion

July 15, 2019

Study Completion

December 15, 2019

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

TU(1)