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Impact on Quality of Life of "Endo-App" (ELEA)

NCT04883073 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-02-06

No results posted yet for this study

Summary

monocentric randomized controlled trial enrolment of endometriosis patients from certified endometriosis centers. Randomization to control group (no Endo App use) vs intervention group (Endo App use) 12 weeks use / no use of Endo App. Evaluation of quality of life at onset, at 4, 8 and 12 weeks by using endometriosis health profile (EHP) 5 as a global index. Statistical analysis of global index at the end minus global index at onset between control and intervention group.

Conditions

  • Endometriosis
  • Endometriosis-related Pain
  • Quality of Life

Interventions

DEVICE

Use of Endo App

Use of Endo App

Sponsors & Collaborators

  • Endo Health GmbH

    collaborator INDUSTRY

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Sebastian D Schäfer, MD PhD · University Hospital Münster, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2023-09-01
Completion
2023-09-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04883073 on ClinicalTrials.gov