NCT03302468

Brief Summary

Endometriosis and adenomyosis can impact on the quality of life including the physical, psychological and social aspects. It is important to include quality of life measurements in evaluating the disease severity and response to any given treatment. The 30-item Endometriosis Health Profile (EHP-30), derived from in-depth interviews of patients with endometriosis, is currently the most reliable questionnaire for health-related quality of life measurement in women with endometriosis. It includes specific questions addressing the problems faced by patients with endometriosis. Unfortunately, this widely accepted tool does not have a traditional Chinese version for the measurement of health-related quality of life of endometriosis in Hong Kong. Furthermore, adenomyosis and endometriosis share similar histological and clinical symptomatology, but application of EHP-30 to adenomyosis has never been studied. The aims of the present study are to translate the EHP-30 English version into traditional Chinese version and to evaluate its psychometric properties in endometriosis and adenomyosis. The hypothesis of this study is that EHP-30 (Hong Kong) traditional Chinese questionnaire has high internal consistency, construct validity, reproducibility as the original English version and can be applicable to Hong Kong Chinese women with endometriosis and adenomyosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

8 years

First QC Date

September 18, 2017

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validation of Endometriosis health profile-30 (EHP-30) traditional Chinese (Hong Kong) version

    internal consistency and construct validity

    Baseline

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Eligible Chinese women attending the Gynaecology clinic of New Territories East Cluster will be invited to join the study.

You may qualify if:

  • Premenopausal
  • Hong Kong Chinese women
  • diagnosed with endometriosis or adenomyosis.

You may not qualify if:

  • uterine fibroid more than 5 cm
  • other premalignant or malignant conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

EndometriosisAdenomyosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wen Ying Fung

    852-35052748

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

September 18, 2017

First Posted

October 5, 2017

Study Start

August 6, 2015

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations